Study Stopped
The AVP-786 program was discontinued, the recruitment was stopped and all participants are no longer being examined or receiving intervention.
Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
2 other identifiers
interventional
1,197
10 countries
227
Brief Summary
This was an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2015
Longer than P75 for phase_3
227 active sites
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
First Submitted
Initial submission to the registry
May 11, 2015
CompletedFirst Posted
Study publicly available on registry
May 18, 2015
CompletedStudy Start
First participant enrolled
November 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2024
CompletedResults Posted
Study results publicly available
October 15, 2025
CompletedOctober 15, 2025
August 1, 2025
8.8 years
May 11, 2015
September 4, 2025
September 30, 2025
Conditions
Outcome Measures
Primary Outcomes (9)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE)is any untoward medical occurrence or unintended change (e.g. physical, psychological, or behavioral), including inter-current illness, whether considered related to treatment or not. An AE can therefore be any unfavorable and unintended sign (including any clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE is defined as an AE that occurred or worsened after the first dose of study treatment up until 30 days after last dose.
From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Number of Participants With Serious TEAE
A serious adverse event (SAE) is any AE occurring at any dose that results in death, life-threatening experience, persistent or significant disability/incapacity, in-patient hospitalization or prolongation of hospitalization or congenital anomaly/birth defect. A serious TEAE is defined as AE that occurred or worsened after the first dose of study treatment up until 30 days after last dose.
From first dose of study drug (in current study) up to 3 months after last dose of study drug (up to Week 64)
Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
Laboratory assessments included clinical chemistry (alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, calcium, carbon dioxide, cholesterol, creatinine kinase, creatinine, gamma glutamyl transferase, glucose, lactate dehydrogenase, magnesium, protein, potassium, sodium, triglycerides and uric acid), hematology (basophils, eosinophils/leukocytes, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils/leukocytes, platelets). Number of participants with clinically significant laboratory test abnormalities were reported as per criteria defined in statistical analysis plan (SAP). The categories with at least one participant with potentially clinically significant laboratory values are reported.
Baseline (current study) up to 52 weeks
Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities
A resting 12-lead ECG was performed for all the participants. ECG data included PR interval (milliseconds {msec}) and QTcF (msec) along with change from baseline in QTcF. Number of participants with potentially clinically significant ECG abnormalities was reported as per the criteria defined in SAP.
Baseline (current study) up to 52 weeks
Number of Participants With Any Abnormal, Clinically Significant Physical and Neurological Examination Finding
The physical examination included assessments of head, eyes, ears, nose, throat, lymph nodes, skin, extremities, respiratory, gastrointestinal, musculoskeletal, cardiovascular, and nervous systems. The neurological examination included assessments of mental status, cranial nerves, motor system, reflexes, coordination, gait and station, and sensory system.
Baseline (current study), Week 52
Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs
Vital signs measurements included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR). Blood pressure (i.e., SBP, DBP) and heart rate were measured in the supine and standing positions after the participant had been in each position for at least 5 and 3 minutes, respectively. Number of participants with clinically significant vital sign abnormalities were reported as per criteria defined in SAP. The categories with at least one participant with clinically significant vital signs abnormalities are reported here.
Baseline (current study) up to 52 weeks
Change From Baseline in the Sheehan Suicidality Tracking Scale (S-STS) Total Score at Week 64
The S-STS is a prospective scale that assesses treatment-emergent suicidal thoughts and behaviors. This is a 20-item scale where each item (except item 17) of the S-STS is scored on a 5-point Likert scale as: 0 = Not at all, 1 = A little, 2 = Moderate, 3 = Very, 4 = Extremely. The S-STS total score is calculated by the sum of items 1a (if present), items 2-11, highest score of item 12 or 16, highest score of item 14 or 15, item 17 and 20. The total score ranges from 0 to 156 (If response to S-STS item 17 =yes, a score of 100 was added to the S-STS total score). Higher scores indicate greater severity of suicidal ideation and/or behavior. A negative change from baseline reflects a reduction in suicidal thoughts or behaviors over time.
Baseline (current study), Week 64
Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 52
The MMSE is a brief questionnaire that is used to assess cognitive impairment and severity of cognitive impairment. The MMSE scale comprises 11 questions or simple tasks concerning orientation, memory, attention, and language to evaluate a participant's cognitive state and are scored as follows: Orientation to Time - 0 to 5; Orientation to Place - 0 to 5; Registration - 0 to 3; Attention and Calculation - 0 to 5; Recall - 0 to 3; Naming - 0 to 2; Repetition - 0 to 1; Comprehension - 0 to 3; Reading - 0 to 1; Writing - 0 to 1; Drawing - 0 to 1. The total score was calculated by summing all of the item scores and ranges from 0 to 30. Higher scores indicate milder cognitive impairment. Negative change from baseline indicates decline in cognitive performance.
Baseline (current study), Week 52
Change From Baseline in the Epworth Sleepiness Scale (ESS) Score at Week 52
The ESS is an 8-item questionnaire that is used to measure sleepiness by rating the probability of falling asleep on 8 different situations that most people engage in during the day. The 8 questions are rated on a 4-point scale (0 to 3) where 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 3 = high chance of dozing. The scores are summed to give an overall score of 0 to 24. A total score of 0 to 9 is considered to be normal. Higher score indicates greater daytime sleepiness. Negative change from baseline indicate improvement in daytime sleepiness.
Baseline (current study), Week 52
Secondary Outcomes (8)
Change From Baseline in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score at Week 64
Baseline (current study), Week 64
Change From Baseline in the Agitation/Aggression, Irritability/Lability, and Aberrant Motor Behavior Domain Scores of the Neuropsychiatric Inventory (NPI) at Week 52
Baseline (current study), Week 52
Change From Baseline in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change-Agitation (mADCS-CGIC-Agitation) Score at Week 64
Baseline (current study), Week 64
Change From Baseline in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score at Week 52
Baseline (current study), Week 52
Change From Baseline in the Patient Global Impression of Change (PGIC) Score at Week 52
Baseline (current study), Week 52
- +3 more secondary outcomes
Other Outcomes (1)
Number of Participants Using Concomitant Medications
Baseline (current study) up to 64 weeks
Study Arms (3)
AVP-786 18 milligrams (mg)
EXPERIMENTALParticipants who received AVP-786-18 (d6-DM 18 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-18 (d6-DM 18 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
AVP-786 28 mg
EXPERIMENTALParticipants who received AVP-786-28 (d6-DM 28 mg/Q 4.9 mg) capsules in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) continued to receive AVP-786-28 (d6-DM 28 mg/Q 4.9 mg), capsules, twice a day for 52 weeks in the current study.
AVP-786 42.63 mg
EXPERIMENTALParticipants who received placebo in the previous studies 15-AVP-786-301 (NCT02442765), 15-AVP-786-302 (NCT02442778), or 17-AVP-786-305 (NCT03393520) and those who had delayed enrolment, started AVP-786-28/4.9 (d6-DM 28 mg/Q 4.9 mg) in the current study and were eventually titrated to receive AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg) capsules, twice a day for 52 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. (Note: A delay in enrollment may include delays associated with COVID-19 restrictions.)
- Participants with a diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group criteria
- Either out-patients or residents of an assisted-living facility or a skilled nursing home
- Participants who delay enrollment must have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline
- Participants who delay enrollment must have a diagnosis of agitation that must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
- Participants who delay enrollment must have a Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at screening and baseline
- Participants who delay enrollment must have a Mini-Mental State Examination (MMSE) score between 6 and 26 (inclusive) at screening and baseline
You may not qualify if:
- Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
- Participants determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator
- Participants who are currently using or were on NUEDEXTA® in the 2 weeks preceding baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (227)
MD First Research, LLC Site #767
Chandler, Arizona, 85286, United States
NoesisPharma, LLC
Phoenix, Arizona, 85032, United States
Perseverance Research Center, LLC
Scottsdale, Arizona, 85254, United States
Health Initiatives Research
Fayetteville, Arkansas, 72703, United States
Advanced Research Center, Inc. Site #835
Anaheim, California, 92805, United States
ATP Clinical Research, Inc. Site #763
Costa Mesa, California, 92626, United States
Behavioral Research Specialists, LLC
Glendale, California, 91206, United States
Irvine Center for Clinical Research
Irvine, California, 92614, United States
Sheenath Clinical Service Site #770
Lakewood, California, 90805, United States
Torrance Clinical Research Institute, Inc. Site #826
Lomita, California, 90717, United States
Collaborative Neuroscience Network, LLC.
Long Beach, California, 90806, United States
Alliance for Wellness, Inc dba Alliance for Research Site #789
Long Beach, California, 90807, United States
NRC Research Institute
Orange, California, 92868, United States
California Neurological Services
Panorama City, California, 91402, United States
Havana Research Institute Site 787
Pasadena, California, 91105, United States
Havana Research Institute
Pasadena, California, 91105, United States
Pacific Research Network, Inc. #1
San Diego, California, 92103, United States
Pacific Research Network, Inc. #2
San Diego, California, 92103, United States
HB Clinical Trials Inc.
Santa Ana, California, 92704, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
Viking Clinical Research
Temecula, California, 92591, United States
Lytle and Weiss, PLLC dba Clinical Trials of the Rockies
Denver, Colorado, 80209, United States
Coastal Connecticut Research, LLC
New London, Connecticut, 06320, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, 06851, United States
Neurology of Central Florida Rsch Ctr Site #803
Altamonte Springs, Florida, 32714, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
Negron Research Services / Humanity Clinical Research Site# 766
Aventura, Florida, 33180, United States
SFM Clinical Research, LLC Site #563
Boca Raton, Florida, 33487, United States
Bradenton Research Center Site #834
Bradenton, Florida, 34205, United States
Clinical Research Of Brandon, LLC Site #838
Brandon, Florida, 33511, United States
Clinical Research of Brandon
Brandon, Florida, 33511, United States
Meridien Research
Brooksville, Florida, 34601, United States
Quantum Laboratories, Inc.
Deerfield Beach, Florida, 33064, United States
Moonshine Research Center, Inc
Doral, Florida, 33166, United States
Science Connections, LLC Site #814
Doral, Florida, 33178, United States
Finlay Medical Research Corp
Greenacres City, Florida, 33467, United States
Direct Helpers Research Center #801
Hialeah, Florida, 33012, United States
Indago Research & Health Center, Inc.
Hialeah, Florida, 33012, United States
New Life Medical Research Center, Inc.
Hialeah, Florida, 33012, United States
Reliable Clinical Research,LLC
Hialeah, Florida, 33012, United States
Research in Miami, Inc
Hialeah, Florida, 33013, United States
The Research Center, Inc
Hialeah, Florida, 33013, United States
Berma Research Group
Hialeah, Florida, 33016, United States
Galiz Research
Hialeah, Florida, 33016, United States
Maxblue Institute
Hialeah, Florida, 33018, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Alphab Global Research #793
Jupiter, Florida, 33458, United States
SIH Research, LLC
Kissimmee, Florida, 34741, United States
Alzheimer's Research and Treatment Center #1
Lake Worth, Florida, 33449, United States
Alzheimer's Research and Treatment Center #2
Lake Worth, Florida, 33449, United States
Alzheimer's Research and Treatment Center #3
Lake Worth, Florida, 33449, United States
Meridien Research Site #558
Lakeland, Florida, 33803, United States
Innovative Clinical Research, Inc. Site #819
Lauderhill, Florida, 33319, United States
Homestead Associates in Research Site# 797
Miami, Florida, 33032, United States
Premier Clinical Research Institute, Inc. #1
Miami, Florida, 33122, United States
Premier Clinical Research Institute, Inc. #2
Miami, Florida, 33122, United States
Central Miami Medical Institute Site #798
Miami, Florida, 33125, United States
Global Medical Institutes, LLC
Miami, Florida, 33125, United States
Optimus U Corp
Miami, Florida, 33125, United States
Project 4 Research #1
Miami, Florida, 33125, United States
Project 4 Research #2
Miami, Florida, 33125, United States
BioMed Research Institute
Miami, Florida, 33126, United States
Finlay Medical Research Corp Site #552
Miami, Florida, 33126, United States
First Class Medical Services Site #807
Miami, Florida, 33126, United States
CCM Clinical Research Group
Miami, Florida, 33133, United States
Innova Clinical Trials
Miami, Florida, 33133, United States
Advance Medical Research Center #1
Miami, Florida, 33135, United States
Advance Medical Research Center #2
Miami, Florida, 33135, United States
Dade Research Center Llc
Miami, Florida, 33135, United States
Vitae Researrch Center LLC
Miami, Florida, 33135, United States
University of Miami
Miami, Florida, 33136, United States
Miami Jewish Health Systems, Inc.
Miami, Florida, 33137, United States
United Health Research Corp. #1
Miami, Florida, 33144, United States
United Health Research Corp. #2
Miami, Florida, 33144, United States
Advanced Medical Center Group
Miami, Florida, 33145, United States
Future Care Solution, LLC
Miami, Florida, 33165, United States
Reliant Medical Research LLC Site #811
Miami, Florida, 33165, United States
Hope Research Network LLC Site #773
Miami, Florida, 33166, United States
Clinical Research Associates of South Florida #1
Miami, Florida, 33172, United States
Clinical Research Associates of South Florida #2
Miami, Florida, 33172, United States
Coral Research Clinic Corp
Miami, Florida, 33175, United States
P&S RESEARCH, LLC. Site #805
Miami, Florida, 33175, United States
Pharmax Research of South Florida
Miami, Florida, 33175, United States
Kendall Research Institute
Miami, Florida, 33183, United States
Nuovida Research Center Corp.
Miami, Florida, 33186, United States
New Med Research, Inc Site #812
Miami Gardens, Florida, 33056, United States
Collier Neurologic Specialists, LLC
Naples, Florida, 34102, United States
Naples Research, Inc
Naples, Florida, 34102, United States
Bayside Clinical Research Site #556
New Port Richey, Florida, 34655, United States
Research Centers of America, LLC
Oakland Park, Florida, 33334, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Combined Research Orlando Site #799
Orlando, Florida, 32807, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174, United States
Innovation Medical Research Center
Palmetto Bay, Florida, 03157, United States
IMIC Inc.
Palmetto Bay, Florida, 33157, United States
Innovation Medical Research Center Site #802
Palmetto Bay, Florida, 33157, United States
University of West Florida
Pensacola, Florida, 32514, United States
Neurostudies Inc. Site#796
Port Charlotte, Florida, 33952, United States
Roskamp Institute
Sarasota, Florida, 34243, United States
Olympian Clinical Research
Tampa, Florida, 33609, United States
VICIS Clinical Research Inc. Site #777
Tampa, Florida, 33615, United States
Compass Research North, LLC
The Villages, Florida, 32162, United States
Neurology Research Institute Palm Beach, LLC #1
West Palm Beach, Florida, 33407, United States
Neurology Research Institute Palm Beach, LLC #2
West Palm Beach, Florida, 33407, United States
Florida Premier Research Institute
Winter Park, Florida, 32789, United States
NeuroTrials Research Inc
Atlanta, Georgia, 30342, United States
Columbus Research & Wellness Institute, INC
Columbus, Georgia, 31904, United States
Medical Research & Health Education Foundation, Inc.
Columbus, Georgia, 31909, United States
NeuroStudies. Net, LLC
Decatur, Georgia, 30033, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256, United States
MidAmerica Neuroscience Research Foundation
Lenexa, Kansas, 66214, United States
Four Rivers Clinical Research Inc.
Paducah, Kentucky, 42003, United States
The Samuel & Alexia Bratton Memory Clinic
Easton, Maryland, 21601, United States
Mir Neurology
Hagerstown, Maryland, 21742, United States
Alzheimer Disease Center Site #804
Braintree, Massachusetts, 02184, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
Alzheimer's Disease Center
Quincy, Massachusetts, 02169, United States
Onyx Clinical Research, LLC
Caro, Michigan, 48723, United States
Michigan State University Department of Neurology
East Lansing, Michigan, 48824, United States
Oakland Medical Research Site #762
Troy, Michigan, 48085, United States
Galen Research
Chesterfield, Missouri, 63005, United States
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, 63141, United States
The NeuroCognitive Institute
Mount Arlington, New Jersey, 07856, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Dent Neurologic Institute
Amherst, New York, 14226, United States
Integrative Clinical Trials LLC #1
Brooklyn, New York, 11229, United States
Integrative Clinical Trials LLC #2
Brooklyn, New York, 11229, United States
Columbia University Medical Center
New York, New York, 10032, United States
Manhattan Behavioral Medicine, PLLC
New York, New York, 10036, United States
Eastside Comprehensive Medical Center, LLC
New York, New York, 10128, United States
Nathan S. Kline Institute for Psychiatric Research #1
Orangeburg, New York, 10962, United States
Nathan S. Kline Institute for Psychiatric Research #571
Orangeburg, New York, 10962, United States
University of Rochester Medical Center
Rochester, New York, 14620, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Burke Rehabilitation Hospital
White Plains, New York, 10605, United States
Herbert Harris, Md, Phd, Pa
Chapel Hill, North Carolina, 27517, United States
ANI Neurology PLLC dba Alzheimer's Memory Center
Charlotte, North Carolina, 28270, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Neurology and Neuroscience Associates, Inc.
Akron, Ohio, 44320, United States
Insight Clinical Trials, LLC Site #570
Beachwood, Ohio, 44122, United States
Valley Medical Research Site #788
Centerville, Ohio, 45459, United States
Valley Medical Research
Centerville, Ohio, 45459, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Cleveland Clinic Lou Ruvo Center for Brain Health at Lakewood Hospital
Lakewood, Ohio, 44107, United States
NorthStar Medical Research Site #778
Middleburg Heights, Ohio, 44130, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, 73112, United States
Heritage Valley Medical Group, Inc.
Beaver, Pennsylvania, 15009, United States
Abington Neurological Associates, LTD
Willow Grove, Pennsylvania, 19090, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914, United States
RH Johnson VA Medical Center
Charleston, South Carolina, 29401, United States
Roper St. Francis Healthcare
Charleston, South Carolina, 29401, United States
BG Neurology
Spartanburg, South Carolina, 29307, United States
Texas Neurology, P.A.
Dallas, Texas, 75214, United States
Neurology Consultants of Dallas, PA
Dallas, Texas, 75231, United States
University Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
InSite Clinical Research Site #576
DeSoto, Texas, 75115, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Houston Methodist Neurological Institute
Houston, Texas, 77030, United States
PRX Research Site #825
Mesquite, Texas, 75149, United States
Texas Medical Research Associates, L.L.C.
San Antonio, Texas, 78238, United States
Ericksen Research and Development
Clinton, Utah, 84015, United States
Pharmaceuticals Research Associates, Inc.
Salt Lake City, Utah, 84107, United States
Clinical Neuroscience Research Associates, Inc. dba The Memory Clinic
Bennington, Vermont, 05201, United States
Neuropsychiatric Associates
Woodstock, Vermont, 05091, United States
Veteran Affairs Medical Center, Salem Virginia
Salem, Virginia, 24153, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Core Clinical Research Site #772
Everett, Washington, 98201, United States
IPC Research
Waukesha, Wisconsin, 53188, United States
Center for Mental Health - Ruse
Rousse, Bulgaria
Mental Health Centre Prof. Nikola Shipkovenski Site #713
Sofia, 1000, Bulgaria
Medical Center Sveti Naum Site #707
Sofia, 1113, Bulgaria
Vrach and Sv. Sv. Kuzma and Damian Site #710
Sofia, 1408, Bulgaria
University Multiprofile Hospital for Active Treatment Alexandrovska Site #704
Sofia, Bulgaria
Medical Center Mladost-M
Varna, 9020, Bulgaria
Medica Plus Medical Center
Veliko Tarnovo, Bulgaria
Dr. Alexander McIntyre Inc.
Penticton, Canada
Fakultni Nemocnice u sv. Anny v Brne Site #722
Brno, Czechia
Fakultní Nemocnice Hradec Králové Site #724
Hradec Kralové, Czechia
NeuropsychiatrieHK Site #729
Hradec Kralové, Czechia
Brain-Soultherapy
Kladno, Czechia
Námestí národního odboje 692 Site #723
Kutná Hora, Czechia
A-Shine s.r.o. Site #731
Pilsen, Czechia
AD71
Prague, Czechia
Clintrial
Prague, Czechia
Neurologicka Ambulance - Forbeli
Prague, Czechia
Neuropsychiatrie Site #726
Prague, Czechia
Vestra Clinics
Rychnov nad Kněžnou, Czechia
Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord Site #535
Saint-Etienne, Auvergne-Rhône-Alpes, France
Centre Hospitalier Universitaire Dijon Bourgogn Site #536
Dijon, France
Centre Hospitalier Universitaire Toulouse - Casselardit Ancely Site #533
Toulouse, France
Dr. Kenessey Albert Kórház-Rendelőintézet
Balassagyarmat, Hungary
Pszichiatriai es Pszichiatriai Rehabilitacios Osztaly Site #586
Budapest, Hungary
Semmelweis Egyetem
Budapest, Hungary
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
Debrecen, Hungary
Dr. Mathe es Tarsa Beteti Tarsasag Site #593
Kalocsa, 6300, Hungary
PsychoTech Clinical Research Site# 580
Pécs, Hungary
Azienda Ospedaliera Sant'Andrea Site #606
Roma, Italy
Fondazione Policlinico Tor Vergata Site #609
Roma, Italy
Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico
Roma, Italy
Twoja Przychodnia - Centrum Medyczne Nowa Sol Site #757
Nowa Sól, Lubusz Voivodeship, 67-100, Poland
RCMed Oddział Sochaczew Site #510
Sochaczew, Masovian Voivodeship, 96-500, Poland
Ksiedza Hugona Kollataja 9
Bydgoszcz, Poland
Care Clinic Clinical Research Site #750
Katowice, Poland
Wielospecjalistyczna Poradnia Lekarska Synapsis Site #741
Katowice, Poland
Krakowska Akademia Neurologii Site #740
Krakow, Poland
Malopolskie Centrum Medyczne Site #747
Krakow, Poland
Medycyna Milorzab Site #743
Lodz, Poland
Solumed Centrum Medyczne Site #753
Poznan, Poland
Centrum Medyczne Euromedis
Szczecin, Poland
Centrum Medyczne NeuroProtect Site #742
Warsaw, Poland
ClinHouse Centrum Medyczne
Zabrze, 41-807, Poland
ACF Neurological Services
Cape Town, South Africa
Cape Trial Centre
Cape Town, South Africa
Flexivest Fourteen Research Centre
Cape Town, South Africa
Apollo Clinical Research Site #623
Johannesburg, South Africa
Medical and Dental Centre
Rosebank, South Africa
Accellacare Alcobendas
Alcobendas, 28100, Spain
Fundació ACE
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital General Universitario de Elche
Elche, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Virgen Macarena Site #649
Seville, Spain
Complejo Asistencial de Zamora Hospital Virgen de la Concha
Zamora, Spain
Hospital Viamed Montecanal Site #643
Zaragoza, Spain
Limitations and Caveats
The study was prematurely terminated due to discontinuation of development of the AVP-786 compound.
Results Point of Contact
- Title
- Clinical Transparency
- Organization
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2015
First Posted
May 18, 2015
Study Start
November 13, 2015
Primary Completion
September 6, 2024
Study Completion
September 6, 2024
Last Updated
October 15, 2025
Results First Posted
October 15, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data will be available after marketing approval in global markets or beginning 1-3 years following article publication. There is no end date to the availability of the data.
- Access Criteria
- Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.