Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
26 participants
INTERVENTIONAL
2021-04-30
2021-11-03
Brief Summary
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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.
Detailed Description
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This study will enroll approximately 112 patients to receive one of three different TAK 994 dose for 8 weeks (active drug extension period). Participants will be randomly assigned to one of these different TAK 994 doses which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).
Following the 8-week Active Drug Extension Period, participants will continue into a 4-week Double-blind Randomized Withdrawal Period and will receive TAK-994 or Placebo.
Participants randomized to TAK-994 will continue to receive the same dose as before.
This multi-center trial will be conducted worldwide. The duration of treatment in this study is 12 weeks plus a 2 week safety follow up period. Participants will visit the clinic 10 times after the first dosing.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active Drug Extension Period: TAK-994 30 mg
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.
TAK-994
TAK-994 tablets.
Active Drug Extension Period: TAK-994 90 mg
TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
TAK-994
TAK-994 tablets.
Active Drug Extension Period: TAK-994 180 mg
TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period.
TAK-994
TAK-994 tablets.
Double-blind Randomized Withdrawal Period: TAK-994 30 mg
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.
TAK-994
TAK-994 tablets.
Double-blind Randomized Withdrawal Period: TAK-994 90 mg
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.
TAK-994
TAK-994 tablets.
Double-blind Randomized Withdrawal Period: TAK-994 180 mg
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.
TAK-994
TAK-994 tablets.
Double-blind Randomized Withdrawal Period: Placebo
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.
Placebo
Placebo-matching tablets.
Interventions
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TAK-994
TAK-994 tablets.
Placebo
Placebo-matching tablets.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Wright Clinical Research
Alabaster, Alabama, United States
Mayo Clinic Arizona 300151190
Phoenix, Arizona, United States
CITrials - Bellflower
Bellflower, California, United States
Santa Monica Clinical Trials
Los Angeles, California, United States
Stanford School of Medicine
Redwood City, California, United States
Pacific Research Network, Inc 150118105
San Diego, California, United States
SDS Clinical Trials, Inc.
Santa Ana, California, United States
Alpine Clinical Research Center 1024762
Boulder, Colorado, United States
Delta Waves Sleep Disorders and Research Center 300148510
Colorado Springs, Colorado, United States
St. Francis Medical Institute
Clearwater, Florida, United States
Sleep Medicine Specialists of South Florida
Miami, Florida, United States
Clinical Site Partners, LLC
Miami, Florida, United States
JSV Clinical Research Study, Inc
Tampa, Florida, United States
Florida Pulmonary Research Institute, LLC 300127039
Winter Park, Florida, United States
NeuroTrials Research, Inc. 300116336
Atlanta, Georgia, United States
Sleep Practitioners, LLC Macon
Macon, Georgia, United States
Clinical Research Institute 300169881
Stockbridge, Georgia, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Fort Wayne Neurological Center 150711262
Fort Wayne, Indiana, United States
University of Kansas Medical Center Research Institute, Inc. University of Kansas Hospital
Kansas City, Kansas, United States
Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders" 150119420
Chevy Chase, Maryland, United States
Beth Israel Deaconess Medical Center CardioVascular Institute
Boston, Massachusetts, United States
Research Carolina Elite
Denver, North Carolina, United States
Clinical Research of Gastonia
Gastonia, North Carolina, United States
Raleigh Neurology Associates 300209729
Raleigh, North Carolina, United States
Raleigh Neurology Associates,300209729
Raleigh, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Intrepid Research
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation 100428
Cleveland, Ohio, United States
Ohio Sleep Medicine and Neuroscience Institute 186
Dublin, Ohio, United States
Respiratory Specialists Berks Schuylkill Respiratory Specialists Ltd
Wyomissing, Pennsylvania, United States
Medical University of South Carolina (MUSC) PARENT
Charleston, South Carolina, United States
Bogan Sleep Consultants, LLC 150711087
Columbia, South Carolina, United States
Sleep Therapy & Research Center 300151246
San Antonio, Texas, United States
Comprehensive Sleep Medicine Associates
Sugar Land, Texas, United States
West Ottawa Sleep Centre
Ottawa, Ontario, Canada
Toronto Sleep Institute
Toronto, Ontario, Canada
Jodha Tishon Inc.
Toronto, Ontario, Canada
Fakultni nemocnice Hradec Kralove Dept of Neurologicka klinika
Hradec Králové, , Czechia
Vseobecna fakultni nemocnice v Praze Dept of Neurologicka klinika 1.LF UK a VFN v Praze
Prague, , Czechia
Terveystalo Helsinki Uniklinikka 300186257
Helsinki, , Finland
Turku University Hospital
Turku, , Finland
Hopital Gui de Chauliac Service de Neurologie
Montpellier, Herault, France
Hopital Roger Salengro - CHU Lille service de neurologie D
Lille, Nord, France
SomnoCenter Budapest
Budapest, , Hungary
IRCCS Oasi Maria SS 300206751
Troina, Enna, Italy
Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche
Bologna, , Italy
Ospedale San Raffaele (San Raffaele Turro) Clinica Neurologica- Div Malattie del Sonno
Milan, , Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata U.O.C. Neurologia
Roma, , Italy
SOUSEIKAI PS Clinic Dept of Internal Medicine
Fukuoka, Fukuoka, Japan
You Ariyoshi Sleep Clinic Dept of Psychiatry
Kitakyushu-shi, Fukuoka, Japan
Kurume University Hospital Dept of Neuropsychiatry
Kurume-shi, Fukuoka, Japan
Kaiseikai Kita Shin Yokohama Internal Medicine Clinic Dept of Internal Medicine
Yokohama, Kanagawa, Japan
Howakai Kuwamizu Hospital Dept of Internal Medicine
Kumamoto, Kumamoto, Japan
Jinyukai Kotorii Isahaya Hospital Dept of Psychiatry
Isahaya-shi, Nagasaki, Japan
Shunkaikai Inoue Hospital Dept of Respiratory Medicine
Nagasaki, Nagasaki, Japan
Gokeikai Osaka Kaisei Hospital Dept of Sleep Medicine
Osaka, Osaka, Japan
Kyowakai Hannan Hospital Dept of Psychiatry
Sakai-shi, Osaka, Japan
Koishikawa Tokyo Hospital Dept of Psychiatry
Bunkyō City, Tokyo-To, Japan
Nihon University Itabashi Hospital Dept of Neuropsychiatry
Itabashi-ku, Tokyo-To, Japan
Yoyogi Sleep Disorder Center Dept of Psychiatry
Shibuya-ku, Tokyo-To, Japan
Sleep Support Clinic Dept of Psychosomatic Medicine/Psychiatry
Shinagawa-ku, Tokyo-To, Japan
Sleep & Stress Clinic Dept of Psychiatry
Shinagawa-ku, Tokyo-To, Japan
Sumida Hospital Phase I
Sumida-ku, Tokyo-To, Japan
The Catholic University of Korea, St. Vincent's Hospital 300187879
Suwon, Gyeonggi-do, South Korea
Keimyung University Dongsan Hospital 300144594
Daegu, , South Korea
Hospital Universitario Araba Sede Santiago Sleep Unit
Vitoria-Gasteiz, Alava, Spain
Hospital General de Castellon Servicio de Neurofisiologia
Castellon, Castellon, Spain
Hospital Clinic de Barcelona Servicio de Neurologia
Barcelona, , Spain
Hospital Vithas Nuestra Senora de America Neurofisiologia Clinica
Madrid, , Spain
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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2021-000251-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TAK-994-1504
Identifier Type: -
Identifier Source: org_study_id