A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy

• ClinicalTrials.gov Identifier: NCT04096560
• Recruitment Status: Terminated
• First Posted: September 20, 2019
• Last Update Posted: April 3, 2023
• Sponsor: Takeda
• Information provided by (Responsible Party): Takeda

Study Description

Brief Summary:

The main aims of the study are:

• To check for side effects from TAK-994 and check what dose of TAK-994 participants can tolerate.
• To check what dose range provides adequate relief of narcolepsy symptoms.
• To check how much TAK-994 stays in the blood of participants, over time.

The study will have 4 parts. Participants can only join 1 of the parts.

A. Participants with type 1 narcolepsy will take either TAK-994 or placebo tablets for 28 days. A placebo looks just like TAK-994 but will not have any medicine in it.

B. Participants with type 1 narcolepsy will take 1 of 3 doses of TAK-994 or placebo tablets for 56 days.

C. Participants with type 1 narcolepsy in China only will take TAK-994 or placebo tablets for 56 days.

D. Participants with type 2 narcolepsy will take either TAK-994 or placebo tablets for 28 days.

Condition or disease	Intervention/treatment	Phase
Narcolepsy Type 1 (NT1); Narcolepsy Type 2 (NT2)	Drug: TAK-994; Drug: Placebo	Phase 2

Detailed Description:

The drug being tested in this study is called TAK-994. TAK-994 is being tested in participants with NT1 and NT2.

The study will enroll up to approximately 202 participants. The study has 4 Parts: Parts A, B, C (China only) and D. Part A - Part A has 2 cohorts [Cohorts (A1a and A1b) A2] In both of these Cohorts, participants will be randomly assigned (by chance, like flipping a coin) in a 2:1 ratio to receive TAK-994 or placebo up to 28 days:

• Part B: In Part B, participants will be randomized in 1:1:1:1 ratio in four parallel arms to receive TAK-994 Dose 1, 2 or 3 or placebo for 56 days. Depending upon their eligibility participants completing Part B of the study treatment will be enrolled to participate in an Extension study.
• Part C: In Part C, participants only from China will be enrolled and randomized in a 2:1 ratio to receive TAK-994 and placebo for 56 days.
• Part D: Participants will be included in two cohorts [Cohorts (D1a and D1b) and D2] and will be randomized in 2:1 ratio to receive TAK-994 or placebo for 28 days. The dose will be selected based on the safety and tolerability in Part A.

This multi-center trial will be conducted in the United States, Japan, China, Italy, France, and European Union. The overall duration of the study is 63 days. Participants will be followed up for 7 days after the last dose of study drug.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 257 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Patients With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 or Narcolepsy Type 2)
• Actual Study Start Date: February 27, 2020
• Actual Primary Completion Date: November 5, 2021
• Actual Study Completion Date: November 5, 2021

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Part A, Cohorts A1a and Cohorts A1b and A2 (Optional), NT1 Participants: Placebo; TAK-994 placebo-matching tablets for 28 days, in participants with NT1.	Drug: Placebo; TAK-994 placebo-matching tablets.
Experimental: Part A, Cohort A1a, NT1 Participants: TAK-994 TBD; TAK-994, tablets, dose level 1 for 28 days, in participants with NT1.	Drug: TAK-994; TAK-994 tablets.
Experimental: Part A, Cohort A1b, NT1 Participants: TAK-994; TAK-994 tablets, dose to be determined (TBD) based on safety, tolerability and/or efficacy in Cohort A1a participants with NT1.	Drug: TAK-994; TAK-994 tablets.
Experimental: Part A, Cohort A2 (Optional), NT1 Participants: TAK-994 TBD; TAK-994 tablets, TBD based on safety, tolerability and/or efficacy data of Cohort A1, for 28 days.	Drug: TAK-994; TAK-994 tablets.
Experimental: Part B, NT1 Participants: TAK-994 Dose 1; TAK-994 dose 1, tablets, for 56 days in participants with NT1.	Drug: TAK-994; TAK-994 tablets.
Experimental: Part B, NT1 Participants: TAK-994 Dose 2; TAK-994 dose 2, tablets, for 56 days in participants with NT1.	Drug: TAK-994; TAK-994 tablets.
Experimental: Part B, NT1 Participants: TAK-994 Dose 3; TAK-994 dose 3, tablets, 56 days in participants with NT1.	Drug: TAK-994; TAK-994 tablets.
Placebo Comparator: Part B, NT1 Participants: Placebo; TAK-994 placebo-matching tablets for 56 days in participants with NT1.	Drug: Placebo; TAK-994 placebo-matching tablets.
Placebo Comparator: Part C, NT1 Participants in China: Placebo; TAK-994 placebo-matching tablets for 56 days, in participants with NT1 in China.	Drug: Placebo; TAK-994 placebo-matching tablets.
Experimental: Part C, NT1 Participants in China: TAK-994; TAK-994 tablets, dose TBD based on safety and tolerability in Part B, for 56 days in participants with NT1 in China.	Drug: TAK-994; TAK-994 tablets.
Placebo Comparator: Part D, Cohort D1a, D1b and D2, NT2 Participants: Placebo; TAK-994 placebo-matching tablets for 28 days, in participants with NT2.	Drug: Placebo; TAK-994 placebo-matching tablets.
Experimental: Part D, Cohort D1a, NT2 Participants: TAK-994; TAK-994 tablets, dose TBD based on safety, tolerability and/or efficacy in Part A , for 28 days in participants with NT2.	Drug: TAK-994; TAK-994 tablets.
Experimental: Part D, Cohort D1b, NT2 Participants: TAK-994; TAK-994 tablets, dose TBD based on safety and/or tolerability efficacy in Cohort D1a participants with NT2.	Drug: TAK-994; TAK-994 tablets.
Experimental: Part D, Cohort D2, NT2 Participants (Optional) : TAK-994 TBD; TAK-994 tablets, TBD based on safety, tolerability and/or efficacy data of Cohort D1, for 28 days.	Drug: TAK-994; TAK-994 tablets.

Outcome Measures

Primary Outcome Measures :

1. Parts A and D: Number of Participants who Experience at least 1 Treatment Emergent Adverse Events (TEAEs) During the Study [ Time Frame: First dose of study treatment to end of study follow-up (up to Day 35) ]
   An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant 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.
2. Parts A and D: Number of Participants who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at least Once Postdose During the Study [ Time Frame: Baseline up to Day 35 ]
   Standard safety laboratory values (serum chemistry, hematology, and urine analysis) will be collected and compared to pre-specified criteria for markedly abnormal values throughout the study.
3. Parts A and D: Number of Participants who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at least Once Postdose During the Study [ Time Frame: Baseline up to Day 35 ]
   Vital signs (body temperature, heart rate, respiratory rate, sitting blood pressure and pulse) will be collected and compared to pre-specified criteria for markedly abnormal values throughout the study.
4. Parts A and D: Number of Participants who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at least Once Postdose During the Study [ Time Frame: Baseline up to Day 35 ]
   A 12 lead ECG will be performed, the ECG values will be compared to pre-specified criteria for markedly abnormal values.
5. Parts B and C: Change From Baseline in Average Sleep Latency as Assessed by the Maintenance of Wakefulness Test (MWT) [ Time Frame: Baseline and Week 8 (Day 56) ]
   The MWT is a validated, objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period. During each MWT session (1 session = 40 minutes), participants will be instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session will be recorded on electroencephalography (EEG). If no sleep has been observed according to these rules, then the latency will be defined as 40 minutes.

Secondary Outcome Measures :

1. Parts A and D: Day 1, Cmax: Maximum Observed Plasma Concentration After Single Dose of TAK-994 [ Time Frame: Day 1: Pre-dose and at multiple time points (Up to 14 hours) post-dose ]
2. Parts A and D: Day 1, Tmax: Time of First Occurrence of Cmax After Single Dose of TAK-994 [ Time Frame: Day 1: Pre-dose and at multiple time points (Up to 14 hours) post-dose ]
3. Parts A and D: Day 1, AUC(0-last): Area Under the Concentration-time Curve from Time 0 to Time of the Last Quantifiable Concentration After Single Dose of TAK-994 [ Time Frame: Day 1: Pre-dose and at multiple time points (Up to 14 hours) post-dose ]
4. Parts A and D: Day 28, Cmax: Maximum Observed Plasma Concentration After Multiple Doses of TAK-994 [ Time Frame: Day 28: Pre-dose and at multiple time points (Up to 14 hours) post-dose ]
5. Parts A and D: Day 28, Tmax: Time of First Occurrence of Cmax After Multiple Doses of TAK-994 [ Time Frame: Day 28: Pre-dose and at multiple time points (Up to 14 hours) post-dose ]
6. Parts A and D: Day 28, AUC(0-t): Area Under the Concentration-time Curve from Time 0 to Time tau Over a Dosing Interval of TAK-994 [ Time Frame: Day 28: Pre-dose and at multiple time points (Up to 14 hours) post-dose ]
7. Parts B and C: Change From Baseline in Subjective Daytime Sleepiness as Assessed by ESS Score [ Time Frame: Baseline and Week 8 (Day 56) ]
   The ESS is a subjective, self-administered, validated scale (scored 0 to 3) to respond to each of the 8 questions of daily life that asks them how likely they are to fall asleep in those situations. The scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range.
8. Parts B and C: Change From Baseline in Weekly Cataplexy Rate (WCR) as Reported in the Patient-Reported Sleep Diary [ Time Frame: Baseline and Week 8 (Day 56) ]
   Participants will complete a daily patient-reported sleep diary to record self-reported narcolepsy symptoms. Participants will record episodes of cataplexy in the diary. The total number of events averaged for a week will be reported.
9. Parts B and C: Number of Participants who Experience at least 1 Treatment Emergent Adverse Events (TEAEs) During the Study [ Time Frame: First dose of study treatment to end of study follow-up (Up to Day 63) ]
   An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant 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.
10. Parts B and C: Number of Participants who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at least Once Postdose During the Study [ Time Frame: Baseline up to Day 63 ]
    Standard safety laboratory values (serum chemistry, hematology, and urine analysis) will be collected and compared to pre-specified criteria for markedly abnormal values throughout the study.
11. Parts B and C: Number of Participants who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at least Once Postdose During the Study [ Time Frame: Baseline up to Day 63 ]
    Vital signs (body temperature, heart rate, respiratory rate, sitting blood pressure and pulse) will be collected and compared to pre-specified criteria for markedly abnormal values throughout the study.
12. Parts B and C: Number of Participants who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at least Once Postdose During the Study [ Time Frame: Baseline up to Day 63 ]
    A 12 lead ECG will be performed, the ECG values will be compared to pre-specified criteria for markedly abnormal values.
13. Change from Baseline in Sleep Latency as Assessed by the Maintenance of Wakefulness Test (MWT) [ Time Frame: Baseline up to Week 4 ]
    The MWT is a validated, objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period. During each MWT session (1 session = 40 minutes), participants will be instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session will be recorded on electroencephalography (EEG). If no sleep has been observed according to these rules, then the latency will be defined as 40 minutes.
14. Change From Baseline in Subjective Daytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS) Score [ Time Frame: Baseline up to Week 4 ]
    The ESS is a subjective, self-administered, validated scale (scored 0 to 3) to respond to each of the 8 questions of daily life that asks them how likely they are to fall asleep in those situations. The scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range.
15. Parts A, B and C: Change From Baseline in Weekly Cataplexy Rate (WCR) as Reported in the Patient-Reported Sleep Diary [ Time Frame: Baseline up to Week 4 ]
    Participants will complete a daily patient-reported sleep diary to record self-reported narcolepsy symptoms. Participants will record episodes of cataplexy in the diary. The total number of events per week will be calculated.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Has a diagnosis of narcolepsy type 1 (NT1) (Parts A-C) or NT2 (Part D) by polysomnography (PSG)/ multiple sleep latency test (MSLT) performed within the past 10 years meeting the minimal acceptable criteria for the proper performance of the PSG/MSLT as outlined by the International Classification of Sleep Disorders, 3rd edition criteria.
2. The participant's Epworth Sleepiness Scale (ESS) score must be greater than or equal to (>=) 10 at Day -1.
3. Must be willing to discontinue all medications used for the treatment of NT1/NT2.
4. The human leukocyte antigen (HLA) genotype: Part A: should test positive for human leukocyte antigen (HLADQB1)* 06:02 (PARTs A-C)- (positive results for either homozygous or heterozygous alleles will be considered "positive" and acceptable). However, if the HLA test is negative (i.e. negative for the heterozygous allele) and the PI feels strongly that the participant has narcolepsy with cataplexy (NT1) then a discussion should be initiated between the PI and the sponsor or designee about the advisability of doing a spinal tap to determine the participant's cerebrospinal fluid (CSF) orexin-1 (OX-1) level. If the CSF result shows the orexin 1 (OX-1) concentration is either less than or equal to<110 pg/mL, or less than one-third of mean values obtained in normal participants with the same standardized assay, then the diagnosis of NT1 is established allowing the participant to be enrolled and randomized, If the CSF OX-1 concentration is >110 pg/mL then the participant will not be allowed to continue in the study .
5. For Parts A, B, and C, during the screening period, participant, must have >=4 partial or complete episodes of cataplexy/week (WCR), and >=4 partial or complete episodes of cataplexy/week during the screening period when off of anticataplexy medications, averaged over 2 weeks (14 consecutive days) minimum. WCR recording taken during following period will be considered for study eligibility: after the participant has stopped taking anticataplexy medications for at least 7 days (minimum 7-day washout) and study Day -2.

Exclusion Criteria:

1. Has a risk of suicide according to endorsement of Item 4 or 5 of the screening/baseline visit Columbia suicide severity rating scale (C-SSRS) or has made a suicide attempt in the previous 12 months.
2. Is an excessive (>600 mg/day) caffeine user 1 week before to the study screening.
3. Has a history of cancer (except carcinoma in situ that has been resolved without further treatment or basal cell skin cancer); past or current epilepsy, seizure; a lifetime history of major psychiatric disorder other than depression or anxiety; a clinically significant history of head injury or head trauma; a history of cerebral ischemia, transient ischemic attack, intracranial aneurysm, or arteriovenous malformation; known coronary artery disease, a history of myocardial infarction, angina, cardiac rhythm abnormality, or heart failure; or current or recent (within 6 months) gastrointestinal disease expected to influence the absorption of drugs. Any history of Roux-en-Y gastric bypass is considered exclusionary and any other surgical intervention that may influence the absorption of drugs should be discussed and approved by the sponsor or designee before enrolling the participants.
4. Has a medical disorder, other than narcolepsy, associated with EDS. This includes clinically significant moderate to severe obstructive sleep apnea and/or with or without treatment with mandibular advanced device hypoglossal nerve stimulation and/or positive airway pressure (PAP) therapy) and/or restless legs syndrome (RLS)/periodic limb movement disorder that has a significant impact on daytime sleepiness. This is evidenced by a clinical history of sleep apnea syndrome (loud snoring with observed respiratory pauses in the absence of nPSG) and/or RLS causing historical sleep onset/maintenance insomnia with resultant insufficient sleep. Or any as evaluated during the clinical interview at screening. pPast PSG data demonstrating any of the following sleep disturbances: apnea Hypopnea Index ≥15 or apnea index ≥10, an oxygen saturation of <80 for >10 seconds, periodic leg movement arousal index of ≥15/h) or as evaluated on interview at the time of screening. Asshould be considered exclusionary unless, based on a clinical evaluation by the investigator, a meaningful change in clinical status has occurred that would impact the results. Because nPSG data is obtained on Day -2, subjects may fail screening if criteria are not meet on the Day -2 nPSG.
5. Has a usual bedtime later than 2400 (12:00 AM, midnight) or an occupation requiring nighttime shift work or variable shift work within the past 6 months or travel within more than 3 time zones, within 14 days before Study Day -2.
6. Has a nicotine dependence that is likely to have an effect on sleep (e.g., a participant who routinely awakens at night to smoke) and/or an unwillingness to discontinue all smoking and nicotine use during the confinement portions of the study. Participants undergoing optional CSF collection.
7. Has a local infection at the puncture site.
8. Has developed signs of lumbar radiculopathy, including lower extremity pain and paresthesia.
9. Has any known focal neurological deficit that might suggest an increase in intracranial pressure.

Contacts and Locations

Locations

United States, Alabama

Wright Clinical Research

Alabaster, Alabama, United States, 35007

United States, Arizona

Mayo Clinic Arizona

Phoenix, Arizona, United States, 85054

United States, California

CITrials - Bellflower

Bellflower, California, United States, 90706

Santa Monica Clinical Trials

Los Angeles, California, United States, 90025

Stanford School of Medicine

Redwood City, California, United States, 94063

Pacific Research Network, Inc

San Diego, California, United States, 92128

SDS Clinical Trials, Inc.

Santa Ana, California, United States, 92705

United States, Colorado

Alpine Clinical Research Center

Boulder, Colorado, United States, 80301

Delta Waves Sleep Disorders and Research Center

Colorado Springs, Colorado, United States, 80918

United States, Florida

St. Francis Medical Institute

Clearwater, Florida, United States, 33765

Sleep Medicine Specialists of South Florida

Miami, Florida, United States, 33126

Clinical Trials of Florida

Miami, Florida, United States, 33186

JSV Clinical Research Study, Inc

Tampa, Florida, United States, 33624

Florida Pulmonary Research Institute, LLC

Winter Park, Florida, United States, 32789

United States, Georgia

NeuroTrials Research, Inc.

Atlanta, Georgia, United States, 30328

iResearch Atlanta, LLC

Decatur, Georgia, United States, 30030

Sleep Practitioners, LLC

Macon, Georgia, United States, 31210

Global Research Associates

Stockbridge, Georgia, United States, 30281

United States, Hawaii

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States, 96817

United States, Indiana

Lutheran Sleep Disorder Center

Fort Wayne, Indiana, United States, 46804

United States, Kansas

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, United States, 66160

United States, Maryland

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

Chevy Chase, Maryland, United States, 20815

United States, Massachusetts

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Neurocare, Inc., dba Neurocare Center for Research

Newton, Massachusetts, United States, 02459

United States, North Carolina

Research Carolina Elite LLC

Denver, North Carolina, United States, 28037

Clinical Research of Gastonia

Gastonia, North Carolina, United States, 28054

Raleigh Neurology Associates

Raleigh, North Carolina, United States, 27607

United States, Ohio

CTI Clinical Research Center

Cincinnati, Ohio, United States, 45245

Intrepid Research

Cincinnati, Ohio, United States, 45245

The Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Ohio Sleep Medicine and Neuroscience Institute

Dublin, Ohio, United States, 43017

United States, Pennsylvania

Respiratory Specialists

Wyomissing, Pennsylvania, United States, 19610

United States, South Carolina

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States, 29425

Bogan Sleep Consultants, LLC

Columbia, South Carolina, United States, 29201

United States, Texas

Sleep Therapy & Research Center

San Antonio, Texas, United States, 78229

Comprehensive Sleep Medicine Associates

Sugar Land, Texas, United States, 77478

Canada, Ontario

West Ottawa Sleep Centre

Ottawa, Ontario, Canada, K2A3Z8

Toronto Sleep Institute

Toronto, Ontario, Canada, M4P 1P2

Jodha Tishon Inc.

Toronto, Ontario, Canada, M5S 3A3

China, Beijing

Xuanwu Hospital Capital Medical University

Beijing, Beijing, China, 100053

China, Guangdong

The First Affiliated Hospital of Jinan University

Tianhe, Guangdong, China, 510630

China, Jilin

The First Hospital of Jilin University

Changchun, Jilin, China, 130021

China, Shanghai

Huashan Hospital, Fudan University

Shanghai, Shanghai, China, 200040

Czechia

Fakultni nemocnice Hradec Kralove

Hradec Kralove, Czechia, 50333

Fakultni nemocnice Ostrava

Ostrava, Czechia, 708 52

Vseobecna fakultni nemocnice v Praze

Praha 2, Czechia, 128 21

Finland

Terveystalo Helsinki Uniklinikka

Helsinki, Finland, 380

Turku University Hospital

Turku, Finland, 20521

France

Hopital Gui de Chauliac

Montpellier, Herault, France, 34295

Hopital Roger Salengro - CHU Lille

Lille, Nord, France, 59037

Hungary

SomnoCenter Budapest

Budapest, Hungary, 1012

Italy

IRCCS Oasi Maria SS

Troina, Enna, Italy, 94018

Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche

Bologna, Italy, 40123

Ospedale San Raffaele (San Raffaele Turro)

Milano, Italy, 20127

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Roma, Italy, 133

Japan

SOUSEIKAI PS Clinic

Fukuoka-shi, Fukuoka-Ken, Japan, 812-0025

You Ariyoshi Sleep Clinic

Kitakyushu-shi, Fukuoka-Ken, Japan, 802-0084

Kurume University Hospital

Kurume-shi, Fukuoka-Ken, Japan, 830-0011

Kaiseikai Kita Shin Yokohama Internal Medicine Clinic

Yokohama-shi, Kanagawa-Ken, Japan, 223-0059

Howakai Kuwamizu Hospital

Kumamoto-shi, Kumamoto-Ken, Japan, 862-0954

Jinyukai Kotorii Isahaya Hospital

Isahaya-shi, Nagasaki-Ken, Japan, 854-0081

Shunkaikai Inoue Hospital

Nagasaki-shi, Nagasaki-Ken, Japan, 850-0045

Gokeikai Osaka Kaisei Hospital

Osaka-shi, Osaka-Fu, Japan, 532-0003

Kyowakai Hannan Hospital

Sakai-shi, Osaka-Fu, Japan, 599-8263

Koishikawa Tokyo Hospital

Bunkyo-ku, Tokyo-To, Japan, 112-0012

Nihon University Itabashi Hospital

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

Yoyogi Sleep Disorder Center

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

Sleep Support Clinic

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

Sleep & Stress Clinic

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

Sumida Hospital

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

Korea, Republic of

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

Suwon-si, Gyeonggi-do, Korea, Republic of, 16247

Keimyung University Dongsan Hospital

Daegu, Korea, Republic of, 42601

Netherlands

Stichting Epilepsie Instelling Nederland, Heemstede

Heemstede, Netherlands, 2103 SW

Kempenhaeghe, Heeze

Heeze, Netherlands, 5591 VE

Spain

Hospital Universitario Araba Sede Santiago

Vitoria, Alava, Spain, 1004

Hospital General de Castellon

Castellon de la Plana, Castellon, Spain, 12004

Hospital Clinic de Barcelona

Barcelona, Spain, 8036

Hospital Vithas Nuestra Senora de America

Madrid, Spain, 28043

Sponsors and Collaborators

Takeda

Investigators

• Study Director: Medical Director, Clinical Science; Takeda

More Information

Additional Information:

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

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT04096560
• Other Study ID Numbers: TAK-994-1501; JapicCTI-205178 ( Registry Identifier: JapicCTI ); 2020-000777-24 ( Registry Identifier: EudraCT ); U1111-1240-0346 ( Registry Identifier: WHO )
• First Posted: September 20, 2019
• Last Update Posted: April 3, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (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.
• URL: https://vivli.org/ourmember/takeda/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:

Drug therapy

Additional relevant MeSH terms:

Narcolepsy; Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders