NCT05980949

Brief Summary

This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
800

participants targeted

Target at P75+ for phase_3

Timeline
15mo left

Started Jul 2023

Typical duration for phase_3

Geographic Reach
31 countries

426 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jul 2023Sep 2027

Study Start

First participant enrolled

July 11, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 31, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2027

Last Updated

June 2, 2026

Status Verified

June 1, 2026

Enrollment Period

4.2 years

First QC Date

July 31, 2023

Last Update Submit

June 1, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of treatment-emergent adverse events (TEAEs)

    The number and percentage of participants with TEAEs will be determined

    From initial dose through 14 days after the final dose (up to 54 weeks)

Secondary Outcomes (2)

  • Incidence of serious TEAEs

    From initial dose through 14 days after the final dose (up to 54 weeks)

  • Incidence of TEAEs leading to withdrawal

    From initial dose through 14 days after the final dose (up to 54 weeks)

Study Arms (1)

KarXT

EXPERIMENTAL

Xanomeline and Trospium Chloride Capsules

Drug: KarXT

Interventions

KarXTDRUG

KarXT 20/2 mg TID (total daily dose \[TDD\] 60/6 mg) KarXT 30/3 mg TID (TDD 90/9 mg) KarXT 40/4 mg TID (TDD 120/12 mg) KarXT 50/5 mg TID (TDD 150/15 mg) KarXT 66.7/6.67 mg TID (TDD 200/20 mg)

KarXT

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have completed study CN012-0026, CN012-0027 or CN012-0056.
  • Subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent CN012-0026, CN012-0027 or CN012-0056 study.
  • Can understand the nature of the study and protocol requirements and provide a signed informed consent or, if deemed not competent to provide informed consent, the subject's legally acceptable representative must provide informed consent, and the subject must provide informed assent before any study assessments are performed.
  • At entry into this study, or any time during the study, if a subject needs to relocate from home or residential assisted-living facility to a nursing home facility, the Sponsor/Medical Monitor must approve the subject's participation in the study.
  • Have an identified or proxy caregiver (spends approximately 10 hours/week with the subject).

You may not qualify if:

  • Significant or severe medical conditions that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results.
  • Clinically significant abnormalities, including any finding(s) from the ECG, laboratory tests, physical examination, or vital signs, at the EOT visit of Study CN012-0026, CN012-0027 or CN012-0056 that the Investigator, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject.
  • Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of CN012-0028.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (426)

Local Institution - 1029

Homewood, Alabama, 35209-6809, United States

WITHDRAWN

Local Institution - 1-13H98LK9

Chandler, Arizona, 85224-6231, United States

WITHDRAWN

Local Institution - 1227

Chandler, Arizona, 85224, United States

WITHDRAWN

Local Institution - 1116

Chandler, Arizona, 85286, United States

WITHDRAWN

Local Institution - 1247

Gilbert, Arizona, 85297, United States

NOT YET RECRUITING

Local Institution - 1217

Phoenix, Arizona, 85006-2528, United States

NOT YET RECRUITING

Local Institution - 1044

Phoenix, Arizona, 85012-2836, United States

WITHDRAWN

Local Institution - 1220

Scottsdale, Arizona, 85260-6742, United States

WITHDRAWN

Advanced Research Center, Inc.

Anaheim, California, 92805-5854, United States

RECRUITING

Local Institution - 1-141NO1DG

Chino, California, 91710, United States

NOT YET RECRUITING

Local Institution - 1001

Costa Mesa, California, 92626, United States

WITHDRAWN

Local Institution - 1151

Encino, California, 91316, United States

WITHDRAWN

Local Institution - 1033

Encino, California, 91436-2201, United States

WITHDRAWN

Local Institution - 1031

Irvine, California, 92612-1246, United States

WITHDRAWN

Local Institution - 1230

Lakewood, California, 90805-4549, United States

NOT YET RECRUITING

Local Institution - 1142

Lancaster, California, 93534-2839, United States

WITHDRAWN

Local Institution - 1117

Los Alamitos, California, 90720-6506, United States

WITHDRAWN

USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)

Los Angeles, California, 90033-5313, United States

RECRUITING

Local Institution - 1228

Orange, California, 92868-2847, United States

NOT YET RECRUITING

SC3 Research - Pasadena - 960 E. Green St

Pasadena, California, 91106, United States

RECRUITING

Local Institution - 1213

Rancho Cucamonga, California, 91730, United States

NOT YET RECRUITING

Local Institution - 1103

Sherman Oaks, California, 91403-2131, United States

COMPLETED

Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS

Walnut Creek, California, 94596, United States

RECRUITING

Local Institution - 1014

Colorado Springs, Colorado, 80907-5302, United States

WITHDRAWN

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

RECRUITING

Local Institution - 1013

Stamford, Connecticut, 06905-1206, United States

WITHDRAWN

Local Institution - 1225

Atlantis, Florida, 33462, United States

WITHDRAWN

Local Institution - 1011

Boca Raton, Florida, 33487-2768, United States

WITHDRAWN

Envision Trials LLC

Bonita Springs, Florida, 34134, United States

RECRUITING

Local Institution - 1015

Bradenton, Florida, 34209-4687, United States

WITHDRAWN

Local Institution - 1156

Clermont, Florida, 34711-5190, United States

WITHDRAWN

K2 Medical Research - Winter Garden

Clermont, Florida, 34711-5933, United States

RECRUITING

JY Research Institute Inc

Cutler Bay, Florida, 33189-1230, United States

RECRUITING

Arrow Clinical Trials

Daytona Beach, Florida, 32117-5532, United States

RECRUITING

Local Institution - 1224

Deerfield Beach, Florida, 33442, United States

WITHDRAWN

Local Institution - 1162

Delray Beach, Florida, 33445-2581, United States

WITHDRAWN

Integrity Clinical Research LLC - 21st Street

Doral, Florida, 33122-1620, United States

RECRUITING

Betancourt Research Services

Doral, Florida, 33172-2638, United States

RECRUITING

Local Institution - 1165

Fort Myers, Florida, 33912-4302, United States

WITHDRAWN

Local Institution - 1155

Hialeah, Florida, 33012-3158, United States

COMPLETED

Direct Helpers Research Center

Hialeah, Florida, 33012-3618, United States

RECRUITING

New Life Medical Research Center -3750 W 16th Ave

Hialeah, Florida, 33012-4648, United States

RECRUITING

Local Institution - 1046

Hialeah, Florida, 33012-5826, United States

NOT YET RECRUITING

Las Mercedes Medical Research - 4440 West 16th Ave

Hialeah, Florida, 33012, United States

RECRUITING

Local Institution - 1-13JED81K

Hialeah, Florida, 33013, United States

WITHDRAWN

Local Institution - 1237

Hialeah, Florida, 33013, United States

WITHDRAWN

Galiz Research

Hialeah, Florida, 33016-1814, United States

RECRUITING

Nexus Clinical Research Center- NRC

Homestead, Florida, 33030, United States

RECRUITING

Local Institution - 1145

Homestead, Florida, 33032-8187, United States

WITHDRAWN

Coral Clinic Research

Homestead, Florida, 33032, United States

RECRUITING

Homestead Associates in Research Inc-30328 Old Dixie Hwy

Homestead, Florida, 33033, United States

RECRUITING

Local Institution - 1127

Largo, Florida, 33777-1359, United States

WITHDRAWN

K2 Medical Research - Maitland

Maitland, Florida, 32751-5669, United States

RECRUITING

Local Institution - 1146

Maitland, Florida, 32751-6138, United States

WITHDRAWN

Premier Clinical Research Institute

Miami, Florida, 33122-1335, United States

RECRUITING

Angels Clinical Research Institute - Miami

Miami, Florida, 33122-1721, United States

RECRUITING

Local Institution - 1005

Miami, Florida, 33125-3724, United States

NOT YET RECRUITING

CCM Clinical Research Group

Miami, Florida, 33133-4231, United States

RECRUITING

Wellness Research Center Inc - Miami

Miami, Florida, 33135-1601, United States

RECRUITING

A & D Doctor Center

Miami, Florida, 33135-2968, United States

RECRUITING

Floridian Neuroscience Institute-1901 SW 1 St

Miami, Florida, 33135, United States

RECRUITING

Local Institution - 1010

Miami, Florida, 33137, United States

WITHDRAWN

MedOne Clinical Research LLC

Miami, Florida, 33145-2455, United States

RECRUITING

Allied Biomedical Research Institute

Miami, Florida, 33155-4630, United States

RECRUITING

My Community Research Center, Inc - 7480 Bird Rd

Miami, Florida, 33155-6630, United States

RECRUITING

Future Care Solution LLC

Miami, Florida, 33165-3947, United States

RECRUITING

Reliant Medical Research

Miami, Florida, 33165, United States

RECRUITING

South Florida Research Phase I-IV, Inc. - Miami

Miami, Florida, 33166, United States

RECRUITING

Novel Clinical Research Center, LLC -7000 SW 97th Ave

Miami, Florida, 33173-1474, United States

RECRUITING

Dade Research Center - Miami FL - 7600 SW 87th Ave

Miami, Florida, 33173, United States

RECRUITING

Florida Research Center, Inc.

Miami, Florida, 33174-2950, United States

RECRUITING

Local Institution - 1158

Miami, Florida, 33175, United States

COMPLETED

Serenity Research Center

Miami, Florida, 33176-1451, United States

RECRUITING

IMIC LLC- 9380 SW 150th Str

Miami, Florida, 33176-7947, United States

RECRUITING

New Gen Health

Miami, Florida, 33176, United States

RECRUITING

Local Institution - 1105

Miami, Florida, 33179-2537, United States

COMPLETED

High Quality Research

Miami, Florida, 33184-1412, United States

RECRUITING

Coral Research Clinic & Coral Diagnostic Center

Miami, Florida, 33186-4643, United States

RECRUITING

ONHEALTH Research Center

Miami, Florida, 33186-5882, United States

RECRUITING

New Med Research

Miami Gardens, Florida, 33056-4000, United States

RECRUITING

San Marcus Research Clinic Inc

Miami Lakes, Florida, 33014-5602, United States

RECRUITING

Meridian International Research

Miami Lakes, Florida, 33014-6435, United States

RECRUITING

Local Institution - 1209

Miami Lakes, Florida, 33014, United States

WITHDRAWN

Ocean Blue Medical Research Center Inc

Miami Springs, Florida, 33166-5260, United States

RECRUITING

Local Institution - 1246

Naples, Florida, 34105, United States

NOT YET RECRUITING

Local Institution - 1212

Ocoee, Florida, 34761-2964, United States

NOT YET RECRUITING

Local Institution - 1101

Okeechobee, Florida, 34972-2568, United States

WITHDRAWN

Nova Psychiatry

Orlando, Florida, 32803, United States

RECRUITING

Local Institution - 1136

Orlando, Florida, 32806-1041, United States

WITHDRAWN

Combined Research Orlando Phase I-IV LLC

Orlando, Florida, 32807-3555, United States

RECRUITING

Neurology Associates of Ormond Beach

Ormond Beach, Florida, 32174-3101, United States

RECRUITING

Local Institution - 1012

Pensacola, Florida, 32504-8608, United States

WITHDRAWN

Local Institution - 1137

Port Orange, Florida, 32127-2914, United States

WITHDRAWN

Local Institution - 1205

Port Orange, Florida, 32127, United States

WITHDRAWN

Local Institution - 1008

St. Petersburg, Florida, 33713-8844, United States

WITHDRAWN

Local Institution - 1133

Sweetwater, Florida, 33182, United States

COMPLETED

Local Institution - 1041

Tampa, Florida, 33607-4629, United States

NOT YET RECRUITING

Angels Clinical Research Institute Tampa - Palm Springs - PPDS

Tampa, Florida, 33614-2869, United States

RECRUITING

Guardian Angel Research

Tampa, Florida, 33614, United States

RECRUITING

Interventional Psychiatry of Tampa Bay

Tampa, Florida, 33629-5837, United States

RECRUITING

Local Institution - 1040

The Villages, Florida, 32159-8955, United States

NOT YET RECRUITING

Local Institution - 1131

Viera, Florida, 32940, United States

WITHDRAWN

Premiere Research Institute at Palm Beach Neurology, PA

West Palm Beach, Florida, 33407-3209, United States

RECRUITING

Agile Clinical Research Trials, LLC

Atlanta, Georgia, 30328-5532, United States

RECRUITING

Local Institution - 1161

Decatur, Georgia, 30030, United States

WITHDRAWN

Local Institution - 1037

Berwyn, Illinois, 60402-2173, United States

WITHDRAWN

Local Institution - 1148

Elgin, Illinois, 60123-9215, United States

WITHDRAWN

Local Institution - 1114

Marrero, Louisiana, 70072-3083, United States

WITHDRAWN

Local Institution - 1223

Belmont, Massachusetts, 02478-1064, United States

NOT YET RECRUITING

Local Institution - 1245

Boston, Massachusetts, 02111-1552, United States

NOT YET RECRUITING

Local Institution - 1243

North Dartmouth, Massachusetts, 02747-2612, United States

NOT YET RECRUITING

Local Institution - 1239

Springfield, Massachusetts, 01103, United States

NOT YET RECRUITING

Local Institution - 1-146Y4PVY

Bloomfield Township, Michigan, 48302-1909, United States

WITHDRAWN

Local Institution - 1248

Bloomfield Township, Michigan, 48302-1909, United States

NOT YET RECRUITING

Local Institution - 1139

Rochester Hills, Michigan, 48307-2760, United States

WITHDRAWN

Precise Research Centers

Flowood, Mississippi, 39232, United States

RECRUITING

Local Institution - 1255

St Louis, Missouri, 63128, United States

NOT YET RECRUITING

Local Institution - 1202

Toms River, New Jersey, 08755, United States

NOT YET RECRUITING

Local Institution - 1232

Toms River, New Jersey, 08755, United States

WITHDRAWN

Local Institution - 1018

Manhasset, New York, 11030-3816, United States

WITHDRAWN

Local Institution - 1017

New York, New York, 10032, United States

WITHDRAWN

Local Institution - 1034

Stony Brook, New York, 11794-0001, United States

WITHDRAWN

Local Institution - 1231

Syracuse, New York, 13203, United States

WITHDRAWN

Local Institution - 1240

Syracuse, New York, 13210-1718, United States

NOT YET RECRUITING

Five Towns Neurology PC -Woodmere - 923 Broadway

Woodmere, New York, 11598-1739, United States

RECRUITING

Local Institution - 1221

Greensboro, North Carolina, 27410-3311, United States

NOT YET RECRUITING

AMC Research, LLC - Flourish - PPDS

Matthews, North Carolina, 28105-8336, United States

RECRUITING

Local Institution - 1215

Morehead City, North Carolina, 28557, United States

NOT YET RECRUITING

Local Institution - 1252

Shelby, North Carolina, 28150-3803, United States

NOT YET RECRUITING

Local Institution - 1201

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

Local Institution - 1122

Dayton, Ohio, 45459-4248, United States

WITHDRAWN

Local Institution - 1249

Shaker Heights, Ohio, 44122-5288, United States

NOT YET RECRUITING

Local Institution - 1016

Oklahoma City, Oklahoma, 73112, United States

NOT YET RECRUITING

Local Institution - 1218

Providence, Rhode Island, 02903, United States

WITHDRAWN

Local Institution - 1035

Charleston, South Carolina, 29425-8900, United States

WITHDRAWN

Local Institution - 1211

Nashville, Tennessee, 37212-3133, United States

NOT YET RECRUITING

Horizon Clinical Research: Gill Neuroscience

Cypress, Texas, 77429-6070, United States

RECRUITING

Local Institution - 1121

DeSoto, Texas, 75115-2043, United States

NOT YET RECRUITING

Local Institution - 1208

El Paso, Texas, 79912-1743, United States

NOT YET RECRUITING

Local Institution - 1022

Flower Mound, Texas, 75028-2011, United States

WITHDRAWN

Local Institution - 1036

Frisco, Texas, 75034-6262, United States

WITHDRAWN

Clinical Trial Network - 7080 Southwest Fwy

Houston, Texas, 77074-2085, United States

RECRUITING

Local Institution - 1238

Plano, Texas, 75093-8225, United States

NOT YET RECRUITING

Local Institution - 1210

San Antonio, Texas, 78229-3901, United States

NOT YET RECRUITING

Local Institution - 1134

Stafford, Texas, 77477-3929, United States

WITHDRAWN

Local Institution - 1241

Arlington, Virginia, 22205, United States

NOT YET RECRUITING

Local Institution - 1254

Kirkland, Washington, 98034-3030, United States

NOT YET RECRUITING

Local Institution - 5004

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1056, Argentina

NOT YET RECRUITING

Local Institution - 5009

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1012AAR, Argentina

NOT YET RECRUITING

Local Institution - 5005

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1058AAJ, Argentina

NOT YET RECRUITING

Local Institution - 5001

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1107, Argentina

NOT YET RECRUITING

Local Institution - 5008

Rosario, Santa Fe Province, S2000DEJ, Argentina

NOT YET RECRUITING

Local Institution - 5002

Buenos Aires, 1199, Argentina

NOT YET RECRUITING

Local Institution - 5006

Buenos Aires, C1428AQK, Argentina

NOT YET RECRUITING

Local Institution - 5007

Córdoba, 5000, Argentina

NOT YET RECRUITING

Local Institution - 5003

Córdoba, 5004, Argentina

NOT YET RECRUITING

Local Institution - 2806

Jette, Brussels Capital, 1090, Belgium

NOT YET RECRUITING

Local Institution - 2801

Hasselt, Limburg, 3500, Belgium

WITHDRAWN

Local Institution - 2802

Leuven, Vlaams Brabant, 3000, Belgium

WITHDRAWN

Local Institution - 2803

Roeselare, West-Vlaanderen, 8800, Belgium

NOT YET RECRUITING

ANIMA Research Center - PPDS

Alken, 3570, Belgium

RECRUITING

Local Institution - 1-13JED87R

Alken, 3570, Belgium

WITHDRAWN

Local Institution - 2805

Kortrijk, 8500, Belgium

NOT YET RECRUITING

Local Institution - 1-13J38ZST

Brasília, Federal District, 70200-730, Brazil

WITHDRAWN

Local Institution - 6201

Brasília, Federal District, 70200-730, Brazil

NOT YET RECRUITING

CPQuali Pesquisa Clínica Sao Paulo

São Paulo, São Paulo, 01228-000, Brazil

RECRUITING

Local Institution - 1-13J38ZS5

São Paulo, São Paulo, 01228-000, Brazil

WITHDRAWN

BR Trials - Pesquisa Clínica

São Paulo, São Paulo, 01236-030, Brazil

RECRUITING

Local Institution - 1-13J38ZTW

São Paulo, São Paulo, 01236-030, Brazil

WITHDRAWN

Local Institution - 6207

São Paulo, São Paulo, 01327-001, Brazil

NOT YET RECRUITING

Local Institution - 1-13J38ZSH

São Paulo, São Paulo, 05403-010, Brazil

WITHDRAWN

Local Institution - 1-13J38ZRS

São Paulo, São Paulo, 87013-250, Brazil

WITHDRAWN

Local Institution - 6203

São Paulo, São Paulo, 87013-250, Brazil

NOT YET RECRUITING

Local Institution - 1-13J338E3

Rio de Janeiro, 22270060, Brazil

WITHDRAWN

Ruschel Medicina

Rio de Janeiro, 22270060, Brazil

RECRUITING

Instituto de Psiquiatria HC FMUSP

São Paulo, 05403-010, Brazil

RECRUITING

Medical Center Sveti Naum EOOD

Sofia, Sofia-Grad, 1113, Bulgaria

RECRUITING

Local Institution - 4505

Sofia, Sofia-Grad, 1431, Bulgaria

WITHDRAWN

Local Institution - 4502

Sofia, Sofia-Grad, 1510, Bulgaria

WITHDRAWN

Local Institution - 4506

Sofia, Sofia-Grad, 1680, Bulgaria

NOT YET RECRUITING

Medical Center Medconsult Pleven OOD

Pleven, 5800, Bulgaria

RECRUITING

University Multiprofile Hospital for Active Treatment Sveti Georgi EAD-66 Peshtersko Shosse blvd

Plovdiv, 4001, Bulgaria

RECRUITING

University Multiprofile Hospital For Active Treatment Kanev AD

Rousse, 7002, Bulgaria

RECRUITING

Local Institution - 4509

Sofia, 1164, Bulgaria

NOT YET RECRUITING

Local Institution - 1-12IRCCNP

Calgary, Alberta, T2N 1N4, Canada

WITHDRAWN

Local Institution - 1603

Hamilton, Ontario, ON L8M 1W9, Canada

WITHDRAWN

Local Institution - 1604

Whitby, Ontario, L1N 5S9, Canada

WITHDRAWN

Local Institution - 1-12IYJCH7

Montreal, Quebec, H4H 1R3, Canada

WITHDRAWN

Local Institution - 1601

Verdun, Quebec, H4H 1R3, Canada

WITHDRAWN

Biomedica Research Group

Providencia, Santiago Metropolitan, 7500000, Chile

RECRUITING

Psicomed Estudios Medicos

Antofagasta, 1270244, Chile

RECRUITING

Especialidades Medicas L Y S

Las Condes, 7550000, Chile

RECRUITING

Local Institution - 7007

Hefei, Anhui, 230022, China

WITHDRAWN

Local Institution - 7004

Beijing, Beijing Municipality, 100025, China

WITHDRAWN

Beijing Anding Hospital Capital Medical University

Beijing, Beijing Municipality, 100088, China

RECRUITING

Local Institution - 7025

Beijing, Beijing Municipality, 100730, China

NOT YET RECRUITING

Local Institution - 7015

Chongqing, Chongqing Municipality, 400016, China

WITHDRAWN

The Affiliated Brain Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 0, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

Local Institution - 7009

Guangzhou, Guangdong, 510260, China

WITHDRAWN

Shenzhen Kangning Hospital

Shenzhen, Guangdong, 518118, China

RECRUITING

Local Institution - 7014

Nanjing, Jiangsu, 210009, China

WITHDRAWN

The Second Affiliated Hospital of Nanjing Medical University - Main Campus

Nanjing, Jiangsu, 210011, China

RECRUITING

Local Institution - 7024

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

Local Institution - 7023

Zhenjiang, Jiangsu, 212001, China

NOT YET RECRUITING

Local Institution - 7012

Nanchang, Jiangxi, 330008, China

WITHDRAWN

Shanghai Mental Health Center - PPDS

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Local Institution - 7028

Shanghai, Shanghai Municipality, 200065, China

NOT YET RECRUITING

Local Institution - 7011

Shanghai, Shanghai Municipality, 200080, China

WITHDRAWN

Local Institution - 7026

Shanghai, Shanghai Municipality, 200233, China

NOT YET RECRUITING

West China Hospital Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

Tianjin Anding Hospital(Tianjin mental Health Center)

Tianjin, Tianjin Municipality, 300222, China

RECRUITING

Local Institution - 7017

Hangzhou, Zhejiang, 310003, China

WITHDRAWN

Local Institution - 7010

Hangzhou, Zhejiang, 310013, China

WITHDRAWN

Local Institution - 7021

Hangzhou, Zhejiang, 310013, China

NOT YET RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

RECRUITING

Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qingchun Campus

Hangzhou, Zhejiang, 310016, China

RECRUITING

Local Institution - 7018

Wenzhou, Zhejiang, 325000, China

WITHDRAWN

Local Institution - 7027

Changsha, 410008, China

NOT YET RECRUITING

Local Institution - 7022

Kunming, 650032, China

NOT YET RECRUITING

Klinicki Bolnicki Centar Zagreb

Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

Local Institution - 1-140R4546

Zagreb, City of Zagreb, 10000, Croatia

WITHDRAWN

Local Institution - 4102

Zagreb, City of Zagreb, 10000, Croatia

NOT YET RECRUITING

Local Institution - 4103

Zagreb, City of Zagreb, 10000, Croatia

WITHDRAWN

Local Institution - 4106

Zagreb, City of Zagreb, 10000, Croatia

NOT YET RECRUITING

Klinika za psihijatriju Vrapce

Zagreb, City of Zagreb, 10090, Croatia

RECRUITING

Local Institution - 4104

Zagreb, City of Zagreb, 10090, Croatia

NOT YET RECRUITING

CLINTRIAL s.r.o.

Prague, Praha, Hlavní Mesto, 100 00, Czechia

RECRUITING

Neuroterapie KH, s.r.o Psychiatricka ambulance

Kutná Hora, 284 01, Czechia

RECRUITING

A-SHINE s.r.o.

Pilsen, 301 00, Czechia

RECRUITING

Local Institution - 4004

Prague, 140 00, Czechia

WITHDRAWN

Local Institution - 4006

Rychnov nad Kněžnou, 516 01, Czechia

NOT YET RECRUITING

Local Institution - 2510

Nice, Alpes-Maritimes, 06100, France

WITHDRAWN

Local Institution - 2511

Tours, Indre-et-Loire, 37044, France

NOT YET RECRUITING

Local Institution - 2501

Reims, Marne, 51100, France

WITHDRAWN

Centre Hospitalier Universitaire Hopitaux de Rouen-1 Rue de Germont

Rouen, Seine-Maritime, 76031, France

RECRUITING

Local Institution - 2513

Toulouse, 31059, France

NOT YET RECRUITING

Local Institution - 2401

Böblingen, Baden-Wurttemberg, 71034, Germany

WITHDRAWN

Local Institution - 2407

Böblingen, Baden-Wurttemberg, 71034, Germany

NOT YET RECRUITING

Local Institution - 2403

Bayreuth, Bavaria, 95445, Germany

WITHDRAWN

Local Institution - 1-13JED8BL

Erbach im Odenwald, Hesse, 64711, Germany

WITHDRAWN

Local Institution - 2402

Homburg, Saarland, 66424, Germany

WITHDRAWN

Local Institution - 2404

Erbach im Odenwald, 64711, Germany

NOT YET RECRUITING

Local Institution - 1-13JED842

Frankfurt am Main, 60528, Germany

WITHDRAWN

Local Institution - 2405

Frankfurt am Main, 60528, Germany

NOT YET RECRUITING

Local Institution - 4805

Athens, Attica, 115 21, Greece

WITHDRAWN

Local Institution - 4803

Athens, Attica, 115 26, Greece

NOT YET RECRUITING

Local Institution - 4802

Chaidari, Athens, Attica, 12462, Greece

WITHDRAWN

Local Institution - 4810

Kalyftaki-N. Kifissia, Attica, 145 64, Greece

NOT YET RECRUITING

Local Institution - 4806

Marousi, Attica, 151 23, Greece

WITHDRAWN

Local Institution - 4801

Heraklion, 71110, Greece

NOT YET RECRUITING

Local Institution - 4811

Thessaloniki, 546 36, Greece

NOT YET RECRUITING

Local Institution - 4601

Pécs, Baranya, 7633, Hungary

NOT YET RECRUITING

Local Institution - 1-13JED893

Szeged, Csongrád megye, 6720, Hungary

WITHDRAWN

Local Institution - 4610

Szeged, Csongrád megye, 6720, Hungary

WITHDRAWN

Local Institution - 4602

Budapest, 1083, Hungary

NOT YET RECRUITING

Local Institution - 4612

Budapest, 1123, Hungary

NOT YET RECRUITING

Local Institution - 1-13JED8D1

Gyöngyös, 3200, Hungary

WITHDRAWN

Local Institution - 4611

Gyöngyös, 3200, Hungary

NOT YET RECRUITING

Local Institution - 4603

Miskolc, 3526, Hungary

WITHDRAWN

Local Institution - 7401

Nagpur, Maharashtra, 440010, India

NOT YET RECRUITING

Local Institution - 7405

Chandigarh, Punjab, 160012, India

NOT YET RECRUITING

Local Institution - 7406

Ajmer, Rajasthan, 305001, India

NOT YET RECRUITING

Local Institution - 7403

Hyderabad, 500034, India

NOT YET RECRUITING

Local Institution - 7404

Kolkata, 700017, India

NOT YET RECRUITING

Local Institution - 7402

Varanasi, 211 005, India

NOT YET RECRUITING

Local Institution - 3101

Jerusalem, Jerusalem, 90000, Israel

NOT YET RECRUITING

Local Institution - 3103

Ashkelon, Tel Aviv, 7830604, Israel

NOT YET RECRUITING

Local Institution - 3102

Petah Tikva, 49100, Israel

NOT YET RECRUITING

Local Institution - 3104

Ramat Gan, 5265601, Israel

NOT YET RECRUITING

Local Institution - 1-140JNJT7

Salerno, Campania, 84131, Italy

WITHDRAWN

Local Institution - 1-13JED80W

Rome, Lazio, 00161, Italy

WITHDRAWN

Local Institution - 2322

Rome, Lazio, 00161, Italy

NOT YET RECRUITING

Local Institution - 1-13JED82O

Rome, Lazio, 00166, Italy

WITHDRAWN

Local Institution - 2320

Rome, Lazio, 00166, Italy

WITHDRAWN

Local Institution - 2301

Rome, Lazio, 00179, Italy

WITHDRAWN

Local Institution - 1-13JED83E

Brescia, Lombardy, 25125, Italy

WITHDRAWN

Local Institution - 2324

Brescia, Lombardy, 25125, Italy

NOT YET RECRUITING

Local Institution - 2304

Milan, Lombardy, 20122, Italy

WITHDRAWN

Local Institution - 2323

Milan, Lombardy, 20149, Italy

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena

Baggiovara, Modena, 41126, Italy

RECRUITING

Local Institution - 2307

Ponderano (Biella), Piedmont, 13875, Italy

NOT YET RECRUITING

Local Institution - 2321

Rome, Roma, 00186, Italy

WITHDRAWN

Local Institution - 2308

Florence, Tuscany, 50139, Italy

WITHDRAWN

Local Institution - 2305

Monza, 20900, Italy

WITHDRAWN

Local Institution - 2302

Pisa, 56126, Italy

WITHDRAWN

Local Institution - 2303

Roma, 00168, Italy

NOT YET RECRUITING

Local Institution - 2309

Roma, 00189, Italy

NOT YET RECRUITING

Local Institution - 1-13H98LYW

Iizuka, Fukuoka, 820-0014, Japan

WITHDRAWN

Local Institution - 7503

Iizuka, Fukuoka, 820-0014, Japan

WITHDRAWN

Local Institution - 7525

Kōriyama, Fukushima, 963-8052, Japan

NOT YET RECRUITING

Local Institution - 7522

Sapporo, Hokkaido, 006-8555, Japan

NOT YET RECRUITING

Local Institution - 7526

Himeji-Shi, Hyōgo, 672-8044, Japan

NOT YET RECRUITING

Local Institution - 1-13H98LIT

Toride-shi, Ibaraki, 302-0004, Japan

WITHDRAWN

Memory Clinic Toride

Toride-shi, Ibaraki, 302-0004, Japan

RECRUITING

Local Institution - 7514

Takamatsu, Kagawa-ken, 760-0065, Japan

NOT YET RECRUITING

Local Institution - 7505

Hadano, Kanagawa, 257-0003, Japan

NOT YET RECRUITING

Local Institution - 7507

Kawasaki-Shi, Kanagawa, 210-0852, Japan

NOT YET RECRUITING

Local Institution - 7520

Yokohama, Kanagawa, 230-0074, Japan

NOT YET RECRUITING

Yokohama City Minato Red Cross Hospital

Yokohama, Kanagawa, 2310801, Japan

RECRUITING

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004, Japan

RECRUITING

National Hospital Organization Utano National Hospital

Kyoto, Kyoto, 616-8255, Japan

RECRUITING

Local Institution - 7506

Tsu, Mie-ken, 514-1101, Japan

NOT YET RECRUITING

Asakayama General Hospital

Sakai, Osaka, 590-0018, Japan

RECRUITING

Local Institution - 7501

Takatsuki, Osaka, 569-1041, Japan

NOT YET RECRUITING

Local Institution - 7512

Yoshinogawa, Tokushima, 776-8585, Japan

NOT YET RECRUITING

Local Institution - 7518

Hachiōji, Tokyo, 193-0811, Japan

NOT YET RECRUITING

Local Institution - 7521

Setagaya-Ku, Tokyo, 154-0004, Japan

NOT YET RECRUITING

Kurumi Clinic

Setagaya-Ku, Tokyo, 156-0041, Japan

RECRUITING

Local Institution - 7528

Setagaya-Ku, Tokyo, 156-0057, Japan

NOT YET RECRUITING

Local Institution - 7527

tabashi City, Tokyo, 173-0015, Japan

NOT YET RECRUITING

Funairi nou clinic

Hiroshima, 730-0844, Japan

RECRUITING

Local Institution - 1-13H98LTZ

Kumamoto, 861-8002, Japan

NOT YET RECRUITING

Local Institution - 7524

Kumamoto, 861-8002, Japan

NOT YET RECRUITING

Local Institution - 7523

Tatebayashi, 374-0037, Japan

NOT YET RECRUITING

Hospital Universitario de Saltillo Dr Gonzalo Valdes Valdes

Saltillo Centro, Coahuila, 25000, Mexico

RECRUITING

Local Institution - 1504

Zona Urbana Río Tijuana, Estado de Baja California, 22010, Mexico

WITHDRAWN

Local Institution - 1507

Zapopan, Jalisco, 45170, Mexico

WITHDRAWN

Hospital Universitario Dr. Jose Eleuterio González

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Local Institution - 1505

Monterrey, Nuevo León, 64620, Mexico

WITHDRAWN

Neurociencias Estudios Clinicos S.C.

Culiacán, Sinaloa, 80020, Mexico

RECRUITING

Local Institution - 1506

México, 03100, Mexico

WITHDRAWN

Local Institution - 6102

Miraflores, Lima region, 15046, Peru

WITHDRAWN

Local Institution - 6101

Callao, Callao 2, Peru

WITHDRAWN

Centrum Medyczne HCP Szpital im. Jana Pawla II

Poznan, Greater Poland Voivodeship, 61-485, Poland

RECRUITING

Osrodek Badan Klinicznych Appletreeclinics

Lódz, Lódzkie, 90-349, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17

Gdansk, Pomeranian Voivodeship, 80-214, Poland

RECRUITING

Local Institution - 1-13JAX170

Gdansk, Pomeranian Voivodeship, 80-952, Poland

WITHDRAWN

Local Institution - 4215

Iława, Warmian-Masurian Voivodeship, 14-200, Poland

NOT YET RECRUITING

Local Institution - 4204

Bydgoszcz, 85-080, Poland

WITHDRAWN

Local Institution - 4208

Katowice, 40-156, Poland

WITHDRAWN

Local Institution - 4205

Katowice, 40-282, Poland

WITHDRAWN

Local Institution - 4213

Kielce, 25-411, Poland

WITHDRAWN

Medycyna Milorzab sp. z o.o.

Lodz, 90-227, Poland

RECRUITING

Pro Salus Sp. z o.o.,sp. k.

Lodz, 91-743, Poland

RECRUITING

NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska -Lublin

Lublin, 20-064, Poland

RECRUITING

Local Institution - 4209

Siemianowice Śląskie, 41-100, Poland

WITHDRAWN

Local Institution - 4216

Sochaczew, 96-500, Poland

NOT YET RECRUITING

Osrodek Badawczo Naukowo Dydaktyczny Chorób Otepiennych im Ksiedza Henryka Kardynala Gulbinowicza

Ścinawa, 59-330, Poland

RECRUITING

Local Institution - 4211

Wroclaw, 50-981, Poland

NOT YET RECRUITING

Local Institution - 2701

Guimarães, Braga District, 4835-044, Portugal

NOT YET RECRUITING

Local Institution - 2704

Lisbon, Lisbon District, 1349-019, Portugal

WITHDRAWN

Local Institution - 2702

Torres Vedras, Lisbon District, 2560-280, Portugal

NOT YET RECRUITING

Local Institution - 2703

Matosinhos Municipality, Porto District, 4454-509, Portugal

NOT YET RECRUITING

Local Institution - 2705

Lisbon, 1649-035, Portugal

NOT YET RECRUITING

Local Institution - 2706

Lisbon, 1998-018, Portugal

WITHDRAWN

Local Institution - 1303

Bayamón, 00961-6910, Puerto Rico

NOT YET RECRUITING

Local Institution - 1301

Bayamón, 961, Puerto Rico

WITHDRAWN

Local Institution - 1305

Carolina, 983, Puerto Rico

WITHDRAWN

Local Institution - 1302

San Juan, 00918-4502, Puerto Rico

NOT YET RECRUITING

Barbara Diaz Hernandez MD Research Inc

San Juan, 00926-3160, Puerto Rico

RECRUITING

CMI Dr. Buhas Ramocea Elena Daniela - Cabinet Medical de Psihiarie

Oradea, Bihor County, 410027, Romania

RECRUITING

Prof Dr Alexandru Obregia Clinical Psychiatric Hospital- Centrul de Sanatate Mintala

Bucharest, 40874, Romania

RECRUITING

Local Institution - 4902

Constanța, 90123, Romania

NOT YET RECRUITING

Local Institution - 4903

Craiova, 200157, Romania

NOT YET RECRUITING

S.C. Carpe Diem SRL

Sibiu, 550281, Romania

RECRUITING

Local Institution - 4307

Belgrade, Belgrade, 101403, Serbia

WITHDRAWN

Local Institution - 4302

Belgrade, Belgrade, 11000, Serbia

NOT YET RECRUITING

Clinical Hospital Center Dragisa Misovic Dedinje

Belgrade, 11000, Serbia

RECRUITING

Local Institution - 4308

Belgrade, 11000, Serbia

NOT YET RECRUITING

Military Medical Academy

Belgrade, 11000, Serbia

RECRUITING

Local Institution - 1-13JAX17Q

Gornja Toponica, 705631, Serbia

WITHDRAWN

Special Hospital for Psychiatric Diseases "Gornja Toponica"

Gornja Toponica, 705631, Serbia

RECRUITING

Special Hospital for Psychiatric Diseases Kovin

Kovin, 26220, Serbia

RECRUITING

Local Institution - 4301

Kragujevac, 34000, Serbia

NOT YET RECRUITING

Local Institution - 4310

Kragujevac, 34000, Serbia

NOT YET RECRUITING

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

RECRUITING

Local Institution - 4309

Novi Sad, 21000, Serbia

NOT YET RECRUITING

Local Institution - 4311

Vršac, 26300, Serbia

WITHDRAWN

Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43

Košice, Košice Region, 041 90, Slovakia

RECRUITING

MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.

Banská Bystrica, 974 04, Slovakia

RECRUITING

KONZILIUM s.r.o

Dubnica nad Váhom, 018 41, Slovakia

RECRUITING

EPAMED s.r.o

Košice, 040 01, Slovakia

RECRUITING

Local Institution - 1-13JED85D

Pezinok, 902 18, Slovakia

WITHDRAWN

Local Institution - 4407

Pezinok, 902 18, Slovakia

COMPLETED

Crystal Comfort, s.r.o.

Vranov nad Topľou, 093 01, Slovakia

RECRUITING

Local Institution - 7208

Buk-gu, Daegu Gwang'yeogsi, 41404, South Korea

WITHDRAWN

Local Institution - 7214

Ansan-si, Gyeonggido, 15355, South Korea

NOT YET RECRUITING

Local Institution - 7207

Seongnam-si, Gyeonggido, 13496, South Korea

WITHDRAWN

Local Institution - 7216

Yongin-si, Gyeonggido, 16995, South Korea

NOT YET RECRUITING

Local Institution - 7205

Incheon, Incheon Gwang'yeogsi, 21565, South Korea

WITHDRAWN

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 03080, South Korea

RECRUITING

Local Institution - 7217

Seoul, Seoul Teugbyeolsi, 06591, South Korea

NOT YET RECRUITING

Local Institution - 7213

Seoul, Seoul Teugbyeolsi, 07804, South Korea

NOT YET RECRUITING

Ewha Womans University Mokdong Hospital

Seoul, Seoul Teugbyeolsi, 7985, South Korea

RECRUITING

The Catholic University of Korea, Yeouido St. Mary's Hospital

Yeongdeungpo-gu, Seoul Teugbyeolsi, 07345, South Korea

RECRUITING

Hallym University Chuncheon Sacred Heart Hospital

Gangwon-do, 200-704, South Korea

RECRUITING

Local Institution - 7202

Seongnam-si, 0, South Korea

WITHDRAWN

Local Institution - 7219

Seoul, 06273, South Korea

NOT YET RECRUITING

Local Institution - 7203

Seoul, 07071, South Korea

WITHDRAWN

Local Institution - 7201

Seoul, 143-729, South Korea

WITHDRAWN

Hanyang University Seoul Hospital

Seoul, 4763, South Korea

RECRUITING

Local Institution - 7210

Seoul, 6351, South Korea

NOT YET RECRUITING

Local Institution - 2211

Majadahonda, Madrid, 28222, Spain

NOT YET RECRUITING

Local Institution - 2213

Málaga, Málaga, 29004, Spain

NOT YET RECRUITING

Local Institution - 2205

Barcelona, 8028, Spain

WITHDRAWN

Local Institution - 2212

Lleida, 25198, Spain

WITHDRAWN

Local Institution - 2207

Madrid, 28006, Spain

WITHDRAWN

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Complejo Asistencial Universitario de Salamanca - H. Clinico

Salamanca, 37007, Spain

RECRUITING

Local Institution - 2201

Seville, 41009, Spain

NOT YET RECRUITING

Hospital Universitario Rio Hortega

Valladolid, 47012, Spain

RECRUITING

Local Institution - 2202

Zamora, 49021, Spain

NOT YET RECRUITING

Hospital Viamed Montecanal

Zaragoza, 50012, Spain

RECRUITING

Local Institution - 4702

Atakum, Samsun, 55139, Turkey (Türkiye)

NOT YET RECRUITING

Local Institution - 4706

Ankara, 06230, Turkey (Türkiye)

NOT YET RECRUITING

Local Institution - 4701

Eskişehir, 26040, Turkey (Türkiye)

NOT YET RECRUITING

Local Institution - 4704

Istanbul, 34093, Turkey (Türkiye)

NOT YET RECRUITING

Local Institution - 4705

Izmir, 35210, Turkey (Türkiye)

NOT YET RECRUITING

Local Institution - 4703

Izmir, 35370, Turkey (Türkiye)

NOT YET RECRUITING

Local Institution - 8007

Lviv, Lviv Oblast, 79053, Ukraine

NOT YET RECRUITING

Local Institution - 8001

Vinnytsia, Vinnytsia Oblast, Ukraine, Ukraine

NOT YET RECRUITING

Local Institution - 8003

Khmelnytskyi, 32120, Ukraine

NOT YET RECRUITING

Local Institution - 8006

Lviv, 79035, Ukraine

NOT YET RECRUITING

Local Institution - 8004

Smila, 20708, Ukraine

NOT YET RECRUITING

Local Institution - 8008

Ternopil, 46027, Ukraine

NOT YET RECRUITING

Local Institution - 8005

Uzhhorod, 88000, Ukraine

NOT YET RECRUITING

Local Institution - 2110

Ilford, Greater London, IG1 4HP, United Kingdom

WITHDRAWN

Local Institution - 2108

Swinton, Greater Manchester, M27 8FF, United Kingdom

WITHDRAWN

Local Institution - 2105

Aberdeen, AB25 2ZL, United Kingdom

WITHDRAWN

Local Institution - 2109

Chertsey, KT16 9AU, United Kingdom

WITHDRAWN

Local Institution - 2106

Leeds, LS7 3JX, United Kingdom

WITHDRAWN

Local Institution - 2104

Motherwell, ML1 4UF, United Kingdom

WITHDRAWN

Local Institution - 2111

Preston, PR2 9HT, United Kingdom

WITHDRAWN

Local Institution - 2107

Sheffield, SouthYorkshire, s5 7JT, United Kingdom

WITHDRAWN

Local Institution - 2103

Swindon, SN3 6BW, United Kingdom

WITHDRAWN

Related Links

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 8, 2023

Study Start

July 11, 2023

Primary Completion (Estimated)

September 7, 2027

Study Completion (Estimated)

September 7, 2027

Last Updated

June 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
See Plan Description
Access Criteria
See Plan Description
More information

Locations