A Study of TAK-994 in Adults With Narcolepsy
Narcolepsy Type 1 (NT 1)
About this trial
This is an interventional treatment trial for Narcolepsy Type 1 (NT 1) focused on measuring Drug Therapy
Eligibility Criteria
Inclusion Criteria:
1. 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.
Exclusion Criteria:
1. Participant has a clinically significant moderate or severe ongoing AE related to the study drug from the prior study.
Sites / Locations
- Wright Clinical Research
- Mayo Clinic Arizona 300151190
- CITrials - Bellflower
- Santa Monica Clinical Trials
- Stanford School of Medicine
- Pacific Research Network, Inc 150118105
- SDS Clinical Trials, Inc.
- Alpine Clinical Research Center 1024762
- Delta Waves Sleep Disorders and Research Center 300148510
- St. Francis Medical Institute
- Sleep Medicine Specialists of South Florida
- Clinical Site Partners, LLC
- JSV Clinical Research Study, Inc
- Florida Pulmonary Research Institute, LLC 300127039
- NeuroTrials Research, Inc. 300116336
- Sleep Practitioners, LLC Macon
- Clinical Research Institute 300169881
- Hawaii Pacific Neuroscience
- Fort Wayne Neurological Center 150711262
- University of Kansas Medical Center Research Institute, Inc. University of Kansas Hospital
- Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders" 150119420
- Beth Israel Deaconess Medical Center CardioVascular Institute
- Research Carolina Elite
- Clinical Research of Gastonia
- Raleigh Neurology Associates 300209729
- Raleigh Neurology Associates,300209729
- CTI Clinical Research Center
- Intrepid Research
- The Cleveland Clinic Foundation 100428
- Ohio Sleep Medicine and Neuroscience Institute 186
- Respiratory Specialists Berks Schuylkill Respiratory Specialists Ltd
- Medical University of South Carolina (MUSC) PARENT
- Bogan Sleep Consultants, LLC 150711087
- Sleep Therapy & Research Center 300151246
- Comprehensive Sleep Medicine Associates
- West Ottawa Sleep Centre
- Toronto Sleep Institute
- Jodha Tishon Inc.
- Fakultni nemocnice Hradec Kralove Dept of Neurologicka klinika
- Vseobecna fakultni nemocnice v Praze Dept of Neurologicka klinika 1.LF UK a VFN v Praze
- Terveystalo Helsinki Uniklinikka 300186257
- Turku University Hospital
- Hopital Gui de Chauliac Service de Neurologie
- Hopital Roger Salengro - CHU Lille service de neurologie D
- SomnoCenter Budapest
- IRCCS Oasi Maria SS 300206751
- Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche
- Ospedale San Raffaele (San Raffaele Turro) Clinica Neurologica- Div Malattie del Sonno
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata U.O.C. Neurologia
- SOUSEIKAI PS Clinic Dept of Internal Medicine
- You Ariyoshi Sleep Clinic Dept of Psychiatry
- Kurume University Hospital Dept of Neuropsychiatry
- Kaiseikai Kita Shin Yokohama Internal Medicine Clinic Dept of Internal Medicine
- Howakai Kuwamizu Hospital Dept of Internal Medicine
- Jinyukai Kotorii Isahaya Hospital Dept of Psychiatry
- Shunkaikai Inoue Hospital Dept of Respiratory Medicine
- Gokeikai Osaka Kaisei Hospital Dept of Sleep Medicine
- Kyowakai Hannan Hospital Dept of Psychiatry
- Koishikawa Tokyo Hospital Dept of Psychiatry
- Nihon University Itabashi Hospital Dept of Neuropsychiatry
- Yoyogi Sleep Disorder Center Dept of Psychiatry
- Sleep Support Clinic Dept of Psychosomatic Medicine/Psychiatry
- Sleep & Stress Clinic Dept of Psychiatry
- Sumida Hospital Phase I
- The Catholic University of Korea, St. Vincent's Hospital 300187879
- Keimyung University Dongsan Hospital 300144594
- Hospital Universitario Araba Sede Santiago Sleep Unit
- Hospital General de Castellon Servicio de Neurofisiologia
- Hospital Clinic de Barcelona Servicio de Neurologia
- Hospital Vithas Nuestra Senora de America Neurofisiologia Clinica
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Active Drug Extension Period: TAK-994 Dose 1
Active Drug Extension Period: TAK-994 Dose 2
Active Drug Extension Period: TAK-994 Dose 3
Double-blind Randomized Withdrawal Period: TAK-994 Dose 1
Double-blind Randomized Withdrawal Period: TAK-994 Dose 2
Double-blind Randomized Withdrawal Period: TAK-994 Dose 3
Double-blind Randomized Withdrawal Period: Placebo
TAK-994 dose 1, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56.
TAK-994 dose 2, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56.
TAK-994 dose 3, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56.
Following the Active Drug Extension Period, participants randomized to active treatment Dose 1 will continue to receive same dose (TAK-994, dose 1, tablets, orally) from Day 57 to Day 84.
Following the Active Drug Extension Period, participants randomized to active treatment Dose 2 will continue to receive same dose (TAK-994, dose 2, tablets, orally) from Day 57 to Day 84.
Following the Active Drug Extension Period, participants randomized to active treatment Dose 3 will continue to receive same dose (TAK-994, dose 3, tablets, orally) from Day 57 to Day 84.
Following the Active Drug Extension Period participants will receive placebo-matching tablets for 4 weeks (from Day 57 to Day 84).