A Study of TAK-994 in Adults With Narcolepsy

NCT04820842 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: TAK-994-15042021-000251-39
• Study Type: interventional
• Target: 26
• Locations: 10 countries
• Sites: 70

Brief Summary

Adults with narcolepsy who have completed the TAK-994-1501 study will be able to take part in this study. The main aim of this study is to check if participants have side effects from TAK-994. Participants will take one of 3 different TAK-994 dose for 8 weeks. Then, half the participants will continue with their dose of TAK-994 and half will take a placebo. In this study, a placebo will look like a TAK-994 tablet but will not have any medicine in it. Participants will take TAK-994 or placebo for 4 weeks. Participants will visit the clinic for a final check-up 2 weeks after their last dose of TAK-994 or placebo. The study doctors will check for side effects from TAK-994 and placebo throughout the study. Participants will continue to record any narcolepsy symptoms as they did in Part B of the TAK 994-1501 study.

Conditions

Narcolepsy Type 1 (NT 1)

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (4)

• Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) During the Active Drug Extension Period

  An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participants administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.

  Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8)

• Number of Participants With at Least One Post-dose Markedly Abnormal Value (MAV) in Laboratory Test During the Active Drug Extension Period

  Clinical laboratory tests included hematology, serum chemistry, and urinalysis. MAV criteria: Hemoglobin \<0.8×lower limit of normal (LLN), \>1.2×upper limit of normal (ULN); Hematocrit \<0.8×LLN, \>1.2×ULN; Red blood cells (RBC) count \<0.8×LLN, \>1.2×ULN; White blood cells (WBC) count \<0.5xLLN, \>1.5xULN; Platelet count \<75x10\^9/liter (L), \>600x10\^9/L; alanine aminotransferase (ALT) \>3xULN; aspartate aminotransferase (AST) \>3xULN; gamma-glutamyl transferase (GGT) \>3xULN; Alkaline phosphatase \>3xULN; Total bilirubin \>1.5xULN; Albumin \<25 grams per liter (g/L); Total protein \<0.8xLLN, \>1.2xULN; Creatinine \>1.5xULN; Blood urea nitrogen \>40 milligrams per deciliters (mg/dL); Sodium \<130 milliequivalents per liter (mEq/L), \>150 mEq/L; Potassium \<3.0 millimoles per liter (mmol/L), \>5.3 mmol/L; creatine phosphokinase (CPK) \>3xULN; Glucose \<50 mg/dL, \>300 mg/dL; Calcium \<7.7 mg/dL, \>11.1 mg/dL. Only categories with at least one participant with event are reported.

  Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8)

• Number of Participants With at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period

  MAV criteria for vital signs were: Pulse \<40 beats per minute (bpm), \>115 bpm; Systolic blood pressure \<90 millimeters of mercury (mmHg), ≥160 mmHg; Diastolic blood pressure \<50 mmHg, ≥100 mmHg, Systolic or Diastolic blood pressure change of \>20, \>30 mmHg from Baseline, Body temperature \>38.5 degree Celsius, Respiratory Rate \>21 breath/minute. Only categories with at least one participant with event are reported. Baseline for this outcome measure is Day 1 of the Active Drug Extension Period.

  Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8)

• Number of Participants With at Least One Post-dose MAV for Electrocardiogram (ECG) Parameters During the Active Drug Extension Period

  MAV criteria for ECG were: Heart rate \<40 bpm, \>115 bpm; PR interval ≤80 milliseconds (msec), ≥200 msec; QT interval with Fridericia correction method (QTcF) Interval ≤300 msec, \>500 msec or ≥30 msec change from baseline and \>450 msec; QRS duration ≤80 msec, ≥180 msec. Only categories with at least one participant with event are reported.

  Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8)

Secondary Outcomes (4)

• Number of Participants With at Least One TEAE During the Double-blind Randomized Withdrawal Period

  Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12)

• Number of Participants With at Least One Post-dose MAV in Laboratory Test During the Double-blind Randomized Withdrawal Period

  Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12)

• Number of Participants With at Least One Post-dose MAV for Vital Signs During the Double-blind Randomized Withdrawal Period

  Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12)

• Number of Participants With at Least One Post-dose MAV for ECG Parameters During the Double-blind Randomized Withdrawal Period

  Up to 4 weeks in the Double-blind Randomized Withdrawal Period (Weeks 9 to 12)

Study Arms (7)

Active Drug Extension Period: TAK-994 30 mg

EXPERIMENTAL

TAK-994 30 mg, twice daily (BID) tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.

Drug: TAK-994

Active Drug Extension Period: TAK-994 90 mg

EXPERIMENTAL

TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.

Drug: TAK-994

Active Drug Extension Period: TAK-994 180 mg

EXPERIMENTAL

TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.

Drug: TAK-994

Double-blind Randomized Withdrawal Period: TAK-994 30 mg

EXPERIMENTAL

Following the Active Drug Extension Period, participants randomized to active treatment 30 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 30 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period.

Drug: TAK-994

Double-blind Randomized Withdrawal Period: TAK-994 90 mg

EXPERIMENTAL

Following the Active Drug Extension Period, participants randomized to active treatment 90 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 90 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period.

Drug: TAK-994

Double-blind Randomized Withdrawal Period: TAK-994 180 mg

EXPERIMENTAL

Following the Active Drug Extension Period, participants randomized to active treatment 180 mg, BID, meeting eligibility specification and continued to receive same dose (TAK-994, 180 mg, BID, tablets, orally) from Day 57 to Day 84 in the Double-blind Randomized Withdrawal Period.

Drug: TAK-994

Double-blind Randomized Withdrawal Period: Placebo

PLACEBO COMPARATOR

Following the Active Drug Extension Period participants meeting eligibility specification and received placebo-matching tablets for 4 weeks (from Day 57 to Day 84) in the Double-blind Randomized Withdrawal Period.

Drug: Placebo

Interventions

TAK-994 DRUG

TAK-994 tablets.

Active Drug Extension Period: TAK-994 180 mg; Active Drug Extension Period: TAK-994 30 mg; Active Drug Extension Period: TAK-994 90 mg; Double-blind Randomized Withdrawal Period: TAK-994 180 mg; Double-blind Randomized Withdrawal Period: TAK-994 30 mg; Double-blind Randomized Withdrawal Period: TAK-994 90 mg

Placebo DRUG

Placebo-matching tablets.

Double-blind Randomized Withdrawal Period: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Participant with a diagnosis of Narcolepsy Type 1 (NT1) who has completed TAK-994-1501 Part B before enrollment (which will occur immediately following the final TAK-994-1501 assessments), and for whom the investigator has no clinical objection they be enrolled.

You may not qualify if:

• \. Participant has a clinically significant moderate or severe ongoing AE related to the study drug from the prior study.

Sponsors & Collaborators

• Takeda: lead

Study Sites (70)

Wright Clinical Research

Alabaster, Alabama, 35007, United States

Location

Mayo Clinic Arizona 300151190

Phoenix, Arizona, 85054, United States

Location

CITrials - Bellflower

Bellflower, California, 90706, United States

Location

Santa Monica Clinical Trials

Los Angeles, California, 90025, United States

Location

Stanford School of Medicine

Redwood City, California, 94063, United States

Location

Pacific Research Network, Inc 150118105

San Diego, California, 92103, United States

Location

SDS Clinical Trials, Inc.

Santa Ana, California, 92705, United States

Location

Alpine Clinical Research Center 1024762

Boulder, Colorado, 80301, United States

Location

Delta Waves Sleep Disorders and Research Center 300148510

Colorado Springs, Colorado, 80918, United States

Location

St. Francis Medical Institute

Clearwater, Florida, 33765, United States

Location

Sleep Medicine Specialists of South Florida

Miami, Florida, 33176, United States

Location

Clinical Site Partners, LLC

Miami, Florida, 33186, United States

Location

JSV Clinical Research Study, Inc

Tampa, Florida, 33624, United States

Location

Florida Pulmonary Research Institute, LLC 300127039

Winter Park, Florida, 32789, United States

Location

NeuroTrials Research, Inc. 300116336

Atlanta, Georgia, 30342, United States

Location

Sleep Practitioners, LLC Macon

Macon, Georgia, 31210, United States

Location

Clinical Research Institute 300169881

Stockbridge, Georgia, 30281, United States

Location

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States

Location

Fort Wayne Neurological Center 150711262

Fort Wayne, Indiana, 46804, United States

Location

University of Kansas Medical Center Research Institute, Inc. University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders" 150119420

Chevy Chase, Maryland, 20815, United States

Location

Beth Israel Deaconess Medical Center CardioVascular Institute

Boston, Massachusetts, 02215, United States

Location

Research Carolina Elite

Denver, North Carolina, 28037, United States

Location

Clinical Research of Gastonia

Gastonia, North Carolina, 28054, United States

Location

Raleigh Neurology Associates 300209729

Raleigh, North Carolina, 27607, United States

Location

Raleigh Neurology Associates,300209729

Raleigh, North Carolina, 27607, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45245, United States

Location

Intrepid Research

Cincinnati, Ohio, 45245, United States

Location

The Cleveland Clinic Foundation 100428

Cleveland, Ohio, 44195, United States

Location

Ohio Sleep Medicine and Neuroscience Institute 186

Dublin, Ohio, 43017, United States

Location

Respiratory Specialists Berks Schuylkill Respiratory Specialists Ltd

Wyomissing, Pennsylvania, 19610, United States

Location

Medical University of South Carolina (MUSC) PARENT

Charleston, South Carolina, 29425, United States

Location

Bogan Sleep Consultants, LLC 150711087

Columbia, South Carolina, 29201, United States

Location

Sleep Therapy & Research Center 300151246

San Antonio, Texas, 78229, United States

Location

Comprehensive Sleep Medicine Associates

Sugar Land, Texas, 77478, United States

Location

West Ottawa Sleep Centre

Ottawa, Ontario, K2A 3Z3, Canada

Location

Toronto Sleep Institute

Toronto, Ontario, M4P 1P2, Canada

Location

Jodha Tishon Inc.

Toronto, Ontario, M5S 3A3, Canada

Location

Fakultni nemocnice Hradec Kralove Dept of Neurologicka klinika

Hradec Králové, 50005, Czechia

Location

Vseobecna fakultni nemocnice v Praze Dept of Neurologicka klinika 1.LF UK a VFN v Praze

Prague, 128 21, Czechia

Location

Terveystalo Helsinki Uniklinikka 300186257

Helsinki, 00380, Finland

Location

Turku University Hospital

Turku, 20521, Finland

Location

Hopital Gui de Chauliac Service de Neurologie

Montpellier, Herault, 34295, France

Location

Hopital Roger Salengro - CHU Lille service de neurologie D

Lille, Nord, 59037, France

Location

SomnoCenter Budapest

Budapest, 1012, Hungary

Location

IRCCS Oasi Maria SS 300206751

Troina, Enna, 94018, Italy

Location

Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche

Bologna, 40123, Italy

Location

Ospedale San Raffaele (San Raffaele Turro) Clinica Neurologica- Div Malattie del Sonno

Milan, 20127, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Tor Vergata U.O.C. Neurologia

Roma, 00133, Italy

Location

SOUSEIKAI PS Clinic Dept of Internal Medicine

Fukuoka, Fukuoka, 812-0025, Japan

Location

You Ariyoshi Sleep Clinic Dept of Psychiatry

Kitakyushu-shi, Fukuoka, 802-0084, Japan

Location

Kurume University Hospital Dept of Neuropsychiatry

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Kaiseikai Kita Shin Yokohama Internal Medicine Clinic Dept of Internal Medicine

Yokohama, Kanagawa, 223-0059, Japan

Location

Howakai Kuwamizu Hospital Dept of Internal Medicine

Kumamoto, Kumamoto, 862-0954, Japan

Location

Jinyukai Kotorii Isahaya Hospital Dept of Psychiatry

Isahaya-shi, Nagasaki, 854-0081, Japan

Location

Shunkaikai Inoue Hospital Dept of Respiratory Medicine

Nagasaki, Nagasaki, 850-0045, Japan

Location

Gokeikai Osaka Kaisei Hospital Dept of Sleep Medicine

Osaka, Osaka, 532-0003, Japan

Location

Kyowakai Hannan Hospital Dept of Psychiatry

Sakai-shi, Osaka, 599-8263, Japan

Location

Koishikawa Tokyo Hospital Dept of Psychiatry

Bunkyō City, Tokyo-To, 112-0012, Japan

Location

Nihon University Itabashi Hospital Dept of Neuropsychiatry

Itabashi-ku, Tokyo-To, 173-8610, Japan

Location

Yoyogi Sleep Disorder Center Dept of Psychiatry

Shibuya-ku, Tokyo-To, 151-0053, Japan

Location

Sleep Support Clinic Dept of Psychosomatic Medicine/Psychiatry

Shinagawa-ku, Tokyo-To, 140-0011, Japan

Location

Sleep & Stress Clinic Dept of Psychiatry

Shinagawa-ku, Tokyo-To, 141-6003, Japan

Location

Sumida Hospital Phase I

Sumida-ku, Tokyo-To, 130-0004, Japan

Location

The Catholic University of Korea, St. Vincent's Hospital 300187879

Suwon, Gyeonggi-do, 16247, South Korea

Location

Keimyung University Dongsan Hospital 300144594

Daegu, 42601, South Korea

Location

Hospital Universitario Araba Sede Santiago Sleep Unit

Vitoria-Gasteiz, Alava, 01004, Spain

Location

Hospital General de Castellon Servicio de Neurofisiologia

Castellon, Castellon, 12004, Spain

Location

Hospital Clinic de Barcelona Servicio de Neurologia

Barcelona, 08036, Spain

Location

Hospital Vithas Nuestra Senora de America Neurofisiologia Clinica

Madrid, 28043, Spain

Location

Related Publications (1)

• Dauvilliers Y, Mignot E, Del Rio Villegas R, Du Y, Hanson E, Inoue Y, Kadali H, Koundourakis E, Meyer S, Rogers R, Scammell TE, Sheikh SI, Swick T, Szakacs Z, von Rosenstiel P, Wu J, Zeitz H, Murthy NV, Plazzi G, von Hehn C. Oral Orexin Receptor 2 Agonist in Narcolepsy Type 1. N Engl J Med. 2023 Jul 27;389(4):309-321. doi: 10.1056/NEJMoa2301940.

  PMID: 37494485 DERIVED

Related Links

• To obtain more information on the study, click here/on this link

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 29, 2021
• Study Start: April 30, 2021
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2021
• Last Updated: December 26, 2023
• Results First Posted: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/ takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

FR (2); CZ (2); ES (4); JP (15); KR (2); FI (2); HU (1); CA (3); US (35); IT (4)