A Study of TAK-994 in Adults With Narcolepsy
- Conditions
- Narcolepsy Type 1 (NT 1)
- Interventions
- Drug: TAK-994Drug: Placebo
- Registration Number
- NCT04820842
- Lead Sponsor
- Takeda
- 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.
- Detailed Description
The drug being tested in the study is called TAK-994. TAK-994, is being tested to treat participants with NT1. Participants who completed Part B of TAK-994-1501(NCT04096560) will be eligible for enrollment in this study.
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 26
- 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.
- Participant has a clinically significant moderate or severe ongoing AE related to the study drug from the prior study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Drug Extension Period: TAK-994 30 mg TAK-994 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. Active Drug Extension Period: TAK-994 90 mg TAK-994 TAK-994 90 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period. Active Drug Extension Period: TAK-994 180 mg TAK-994 TAK-994 180 mg, BID, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56 in the Active Drug Extension Period. Double-blind Randomized Withdrawal Period: TAK-994 30 mg TAK-994 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. Double-blind Randomized Withdrawal Period: TAK-994 90 mg TAK-994 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. Double-blind Randomized Withdrawal Period: TAK-994 180 mg TAK-994 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. Double-blind Randomized Withdrawal Period: Placebo 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.
- Primary Outcome Measures
Name Time Method Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) During the Active Drug Extension Period Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8) 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.
Number of Participants With at Least One Post-dose Markedly Abnormal Value (MAV) in Laboratory Test During the Active Drug Extension Period Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8) 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.
Number of Participants With at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8) 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.
Number of Participants With at Least One Post-dose MAV for Electrocardiogram (ECG) Parameters During the Active Drug Extension Period Up to 8 weeks in the Active Drug Extension Period (Weeks 1 to 8) 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.
- Secondary Outcome Measures
Name Time Method 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) MAV criteria for vital signs were: Pulse \<40 bpm, \>115 bpm; Systolic blood pressure \<90 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 Double-blind Randomized Withdrawal Period (Day 57 of this study).
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) MAV criteria for ECG were: Heart rate \<40 bpm, \>115 bpm; PR interval ≤80 msec, ≥200 msec; 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.
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) An 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.
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) Clinical laboratory tests included hematology, serum chemistry, and urinalysis. MAV criteria: Hemoglobin \<0.8×LLN, \>1.2×ULN; Hematocrit \<0.8×LLN, \>1.2×ULN; RBC count \<0.8×LLN, \>1.2×ULN; WBC count \<0.5xLLN, \>1.5xULN; Platelet count \<75x10\^9/L, \>600x10\^9/L; ALT \>3xULN; AST \>3xULN; GGT \>3xULN; Alkaline phosphatase \>3xULN; Total bilirubin \>1.5xULN; Albumin \<25 g/L; Total protein \<0.8x LLN, \>1.2xULN; Creatinine \>1.5xULN; Blood urea nitrogen \>40 mg/dL; Sodium \<130 mEq/L, \>150 mEq/L; Potassium \<3.0 mmol/L, \>5.3 mmol/L; CPK \>3xULN; Glucose \<50 mg/dL, \>300 mg/dL; Calcium \<7.7 mg/dL, \>11.1 mg/dL.
Trial Locations
- Locations (70)
Raleigh Neurology Associates,300209729
🇺🇸Raleigh, North Carolina, United States
Fort Wayne Neurological Center 150711262
🇺🇸Fort Wayne, Indiana, United States
Turku University Hospital
🇫🇮Turku, Finland
SomnoCenter Budapest
🇭🇺Budapest, Hungary
Sleep Medicine Specialists of South Florida
🇺🇸Miami, Florida, United States
Clinical Site Partners, LLC
🇺🇸Miami, Florida, United States
NeuroTrials Research, Inc. 300116336
🇺🇸Atlanta, Georgia, United States
Beth Israel Deaconess Medical Center CardioVascular Institute
🇺🇸Boston, Massachusetts, United States
The Cleveland Clinic Foundation 100428
🇺🇸Cleveland, Ohio, United States
Pacific Research Network, Inc 150118105
🇺🇸San Diego, California, United States
Intrepid Research
🇺🇸Cincinnati, Ohio, United States
Stanford School of Medicine
🇺🇸Redwood City, California, United States
Delta Waves Sleep Disorders and Research Center 300148510
🇺🇸Colorado Springs, Colorado, United States
CITrials - Bellflower
🇺🇸Bellflower, California, United States
Toronto Sleep Institute
🇨🇦Toronto, Ontario, Canada
SDS Clinical Trials, Inc.
🇺🇸Santa Ana, California, United States
Jodha Tishon Inc.
🇨🇦Toronto, Ontario, Canada
Kurume University Hospital Dept of Neuropsychiatry
🇯🇵Kurume-shi, Fukuoka-Ken, Japan
Santa Monica Clinical Trials
🇺🇸Los Angeles, California, United States
Comprehensive Sleep Medicine Associates
🇺🇸Sugar Land, Texas, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Koishikawa Tokyo Hospital Dept of Psychiatry
🇯🇵Bunkyo-ku, Tokyo-To, Japan
The Catholic University of Korea, St. Vincent's Hospital 300187879
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
West Ottawa Sleep Centre
🇨🇦Ottawa, Ontario, Canada
Bogan Sleep Consultants, LLC 150711087
🇺🇸Columbia, South Carolina, United States
Hospital General de Castellon Servicio de Neurofisiologia
🇪🇸Castellon de la Plana, Castellon, Spain
Hospital Clinic de Barcelona Servicio de Neurologia
🇪🇸Barcelona, Spain
Hospital Vithas Nuestra Senora de America Neurofisiologia Clinica
🇪🇸Madrid, Spain
Gokeikai Osaka Kaisei Hospital Dept of Sleep Medicine
🇯🇵Osaka-shi, Osaka-Fu, Japan
Hospital Universitario Araba Sede Santiago Sleep Unit
🇪🇸Vitoria, Alava, Spain
Yoyogi Sleep Disorder Center Dept of Psychiatry
🇯🇵Shibuya-ku, Tokyo-To, Japan
Sumida Hospital Phase I
🇯🇵Sumida-ku, Tokyo-To, Japan
Jinyukai Kotorii Isahaya Hospital Dept of Psychiatry
🇯🇵Isahaya-shi, Nagasaki-Ken, Japan
Shunkaikai Inoue Hospital Dept of Respiratory Medicine
🇯🇵Nagasaki-shi, Nagasaki-Ken, Japan
Mayo Clinic Arizona 300151190
🇺🇸Phoenix, Arizona, United States
Sleep Therapy & Research Center 300151246
🇺🇸San Antonio, Texas, United States
JSV Clinical Research Study, Inc
🇺🇸Tampa, Florida, United States
Wright Clinical Research
🇺🇸Alabaster, Alabama, United States
Alpine Clinical Research Center 1024762
🇺🇸Boulder, Colorado, United States
Florida Pulmonary Research Institute, LLC 300127039
🇺🇸Winter Park, Florida, United States
Clinical Research Institute 300169881
🇺🇸Stockbridge, Georgia, United States
Sleep Practitioners, LLC Macon
🇺🇸Macon, Georgia, United States
Clinical Research of Gastonia
🇺🇸Gastonia, North Carolina, 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
Raleigh Neurology Associates 300209729
🇺🇸Raleigh, North Carolina, United States
Respiratory Specialists Berks Schuylkill Respiratory Specialists Ltd
🇺🇸Wyomissing, Pennsylvania, United States
Terveystalo Helsinki Uniklinikka 300186257
🇫🇮Helsinki, Finland
Fakultni nemocnice Hradec Kralove Dept of Neurologicka klinika
🇨🇿Hradec Kralove, Czechia
Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche
🇮🇹Bologna, Italy
Hopital Gui de Chauliac Service de Neurologie
🇫🇷Montpellier, Herault, France
Vseobecna fakultni nemocnice v Praze Dept of Neurologicka klinika 1.LF UK a VFN v Praze
🇨🇿Praha 2, Czechia
Azienda Ospedaliera Universitaria Policlinico Tor Vergata U.O.C. Neurologia
🇮🇹Roma, Italy
Ospedale San Raffaele (San Raffaele Turro) Clinica Neurologica- Div Malattie del Sonno
🇮🇹Milano, Italy
SOUSEIKAI PS Clinic Dept of Internal Medicine
🇯🇵Fukuoka-shi, Fukuoka-Ken, Japan
Howakai Kuwamizu Hospital Dept of Internal Medicine
🇯🇵Kumamoto-shi, Kumamoto-Ken, Japan
You Ariyoshi Sleep Clinic Dept of Psychiatry
🇯🇵Kitakyushu-shi, Fukuoka-Ken, Japan
Kaiseikai Kita Shin Yokohama Internal Medicine Clinic Dept of Internal Medicine
🇯🇵Yokohama-shi, Kanagawa-Ken, Japan
Kyowakai Hannan Hospital Dept of Psychiatry
🇯🇵Sakai-shi, Osaka-Fu, Japan
Nihon University Itabashi Hospital Dept of Neuropsychiatry
🇯🇵Itabashi-ku, Tokyo-To, Japan
Keimyung University Dongsan Hospital 300144594
🇰🇷Daegu, Korea, Republic of
Research Carolina Elite
🇺🇸Denver, North Carolina, United States
St. Francis Medical Institute
🇺🇸Clearwater, Florida, United States
Hawaii Pacific Neuroscience
🇺🇸Honolulu, Hawaii, United States
Ohio Sleep Medicine and Neuroscience Institute 186
🇺🇸Dublin, Ohio, United States
Sleep & Stress Clinic Dept of Psychiatry
🇯🇵Shinagawa-ku, Tokyo-To, Japan
Sleep Support Clinic Dept of Psychosomatic Medicine/Psychiatry
🇯🇵Shinagawa-ku, Tokyo-To, Japan
Medical University of South Carolina (MUSC) PARENT
🇺🇸Charleston, South Carolina, United States
IRCCS Oasi Maria SS 300206751
🇮🇹Troina, Enna, Italy
Hopital Roger Salengro - CHU Lille service de neurologie D
🇫🇷Lille Cedex, Nord, France