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A Study of TAK-994 in Adults With Narcolepsy

Primary Purpose

Narcolepsy Type 1 (NT 1)

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TAK-994
Placebo
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Narcolepsy Type 1 (NT 1) focused on measuring Drug Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

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

Arm Description

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).

Outcomes

Primary Outcome Measures

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.
Number of Participants with at Least One Post-dose Markedly Abnormal Value (MAV) in Laboratory Test During the Active Drug Extension Period
Markedly abnormal values for laboratory tests (hematology, serum chemistries, and urinalysis) will be collected as per pre-specified criteria.
Number of Participants with at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period
Markedly abnormal values for vital signs (body temperature, heart rate, respiratory rate, sitting blood pressure and pulse) will be collected as per pre-specified criteria.
Number of Participants with at Least One Post-dose MAV for Electrocardiogram (ECG) Parameters During the Active Drug Extension Period
A 12 lead ECG will be performed and markedly abnormal values. will be collected as per pre-specified criteria.

Secondary Outcome Measures

Number of Participants with at Least One TEAE During the Randomized Withdrawal Period of the Study
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, 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 for Laboratory Test During the Randomized Withdrawal Period
Markedly abnormal values for laboratory tests for (hematology, serum chemistries, and urinalysis) will be collected as per pre-specified criteria.
Number of Participants with at Least One Post-dose MAV for Vital Signs During the Randomized Withdrawal Period
Markedly abnormal values (body temperature, heart rate, respiratory rate, sitting blood pressure and pulse) will be collected as per pre-specified criteria.
Number of Participants with at Least One Post-dose MAV for ECG Parameters During the Randomized Withdrawal Period
A 12 lead ECG will be performed and markedly abnormal values will be collected as per pre-specified criteria.

Full Information

First Posted
March 26, 2021
Last Updated
October 5, 2022
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT04820842
Brief Title
A Study of TAK-994 in Adults With Narcolepsy
Official Title
A Dose-Blind Extension Study With Double-blind, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Safety and Explore the Pharmacokinetics and Pharmacodynamics of TAK-994 in Adults With Narcolepsy With Cataplexy (Narcolepsy Type 1)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
A safety signal has emerged in Phase 2 studies of TAK-994. As an immediate precautionary measure, Takeda has suspended dosing of patients and has decided to stop Phase 2 studies early.
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
November 3, 2021 (Actual)
Study Completion Date
November 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy Type 1 (NT 1)
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Drug Extension Period: TAK-994 Dose 1
Arm Type
Experimental
Arm Description
TAK-994 dose 1, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56.
Arm Title
Active Drug Extension Period: TAK-994 Dose 2
Arm Type
Experimental
Arm Description
TAK-994 dose 2, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56.
Arm Title
Active Drug Extension Period: TAK-994 Dose 3
Arm Type
Experimental
Arm Description
TAK-994 dose 3, tablets, orally, from Day 1 (Day 57 of previous study) to Day 56.
Arm Title
Double-blind Randomized Withdrawal Period: TAK-994 Dose 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Double-blind Randomized Withdrawal Period: TAK-994 Dose 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Double-blind Randomized Withdrawal Period: TAK-994 Dose 3
Arm Type
Experimental
Arm Description
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.
Arm Title
Double-blind Randomized Withdrawal Period: Placebo
Arm Type
Placebo Comparator
Arm Description
Following the Active Drug Extension Period participants will receive placebo-matching tablets for 4 weeks (from Day 57 to Day 84).
Intervention Type
Drug
Intervention Name(s)
TAK-994
Intervention Description
TAK-994 tablets.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo-matching tablets.
Primary Outcome Measure Information:
Title
Number of Participants with at Least One Treatment Emergent Adverse Event (TEAE) During the Active Drug Extension Period
Description
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.
Time Frame
Up to Week 8
Title
Number of Participants with at Least One Post-dose Markedly Abnormal Value (MAV) in Laboratory Test During the Active Drug Extension Period
Description
Markedly abnormal values for laboratory tests (hematology, serum chemistries, and urinalysis) will be collected as per pre-specified criteria.
Time Frame
Baseline up to Week 8
Title
Number of Participants with at Least One Post-dose MAV for Vital Signs During the Active Drug Extension Period
Description
Markedly abnormal values for vital signs (body temperature, heart rate, respiratory rate, sitting blood pressure and pulse) will be collected as per pre-specified criteria.
Time Frame
Baseline up to Week 8
Title
Number of Participants with at Least One Post-dose MAV for Electrocardiogram (ECG) Parameters During the Active Drug Extension Period
Description
A 12 lead ECG will be performed and markedly abnormal values. will be collected as per pre-specified criteria.
Time Frame
Baseline up to Week 8
Secondary Outcome Measure Information:
Title
Number of Participants with at Least One TEAE During the Randomized Withdrawal Period of the Study
Description
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, 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.
Time Frame
Weeks 8 to 14
Title
Number of Participants with at Least One Post-dose MAV for Laboratory Test During the Randomized Withdrawal Period
Description
Markedly abnormal values for laboratory tests for (hematology, serum chemistries, and urinalysis) will be collected as per pre-specified criteria.
Time Frame
Weeks 8 to 14
Title
Number of Participants with at Least One Post-dose MAV for Vital Signs During the Randomized Withdrawal Period
Description
Markedly abnormal values (body temperature, heart rate, respiratory rate, sitting blood pressure and pulse) will be collected as per pre-specified criteria.
Time Frame
Weeks 8 to 14
Title
Number of Participants with at Least One Post-dose MAV for ECG Parameters During the Randomized Withdrawal Period
Description
A 12 lead ECG will be performed and markedly abnormal values will be collected as per pre-specified criteria.
Time Frame
Weeks 8 to 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Wright Clinical Research
City
Alabaster
State/Province
Alabama
ZIP/Postal Code
35007
Country
United States
Facility Name
Mayo Clinic Arizona 300151190
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
CITrials - Bellflower
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Santa Monica Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Stanford School of Medicine
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Pacific Research Network, Inc 150118105
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
SDS Clinical Trials, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Alpine Clinical Research Center 1024762
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Delta Waves Sleep Disorders and Research Center 300148510
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
St. Francis Medical Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Sleep Medicine Specialists of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Clinical Site Partners, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
JSV Clinical Research Study, Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Facility Name
Florida Pulmonary Research Institute, LLC 300127039
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
NeuroTrials Research, Inc. 300116336
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Sleep Practitioners, LLC Macon
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
Clinical Research Institute 300169881
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Hawaii Pacific Neuroscience
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Fort Wayne Neurological Center 150711262
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
University of Kansas Medical Center Research Institute, Inc. University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders" 150119420
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Beth Israel Deaconess Medical Center CardioVascular Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Research Carolina Elite
City
Denver
State/Province
North Carolina
ZIP/Postal Code
28037
Country
United States
Facility Name
Clinical Research of Gastonia
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Raleigh Neurology Associates 300209729
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Raleigh Neurology Associates,300209729
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Intrepid Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
The Cleveland Clinic Foundation 100428
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio Sleep Medicine and Neuroscience Institute 186
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
Facility Name
Respiratory Specialists Berks Schuylkill Respiratory Specialists Ltd
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Medical University of South Carolina (MUSC) PARENT
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Bogan Sleep Consultants, LLC 150711087
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Sleep Therapy & Research Center 300151246
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Comprehensive Sleep Medicine Associates
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
West Ottawa Sleep Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2A 3Z3
Country
Canada
Facility Name
Toronto Sleep Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4P 1P2
Country
Canada
Facility Name
Jodha Tishon Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 3A3
Country
Canada
Facility Name
Fakultni nemocnice Hradec Kralove Dept of Neurologicka klinika
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze Dept of Neurologicka klinika 1.LF UK a VFN v Praze
City
Praha 2
ZIP/Postal Code
128 21
Country
Czechia
Facility Name
Terveystalo Helsinki Uniklinikka 300186257
City
Helsinki
ZIP/Postal Code
00380
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Hopital Gui de Chauliac Service de Neurologie
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Roger Salengro - CHU Lille service de neurologie D
City
Lille Cedex
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
SomnoCenter Budapest
City
Budapest
ZIP/Postal Code
1012
Country
Hungary
Facility Name
IRCCS Oasi Maria SS 300206751
City
Troina
State/Province
Enna
ZIP/Postal Code
94018
Country
Italy
Facility Name
Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche
City
Bologna
ZIP/Postal Code
40123
Country
Italy
Facility Name
Ospedale San Raffaele (San Raffaele Turro) Clinica Neurologica- Div Malattie del Sonno
City
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata U.O.C. Neurologia
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
SOUSEIKAI PS Clinic Dept of Internal Medicine
City
Fukuoka-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
812-0025
Country
Japan
Facility Name
You Ariyoshi Sleep Clinic Dept of Psychiatry
City
Kitakyushu-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
802-0084
Country
Japan
Facility Name
Kurume University Hospital Dept of Neuropsychiatry
City
Kurume-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Kaiseikai Kita Shin Yokohama Internal Medicine Clinic Dept of Internal Medicine
City
Yokohama-shi
State/Province
Kanagawa-Ken
ZIP/Postal Code
223-0059
Country
Japan
Facility Name
Howakai Kuwamizu Hospital Dept of Internal Medicine
City
Kumamoto-shi
State/Province
Kumamoto-Ken
ZIP/Postal Code
862-0954
Country
Japan
Facility Name
Jinyukai Kotorii Isahaya Hospital Dept of Psychiatry
City
Isahaya-shi
State/Province
Nagasaki-Ken
ZIP/Postal Code
854-0081
Country
Japan
Facility Name
Shunkaikai Inoue Hospital Dept of Respiratory Medicine
City
Nagasaki-shi
State/Province
Nagasaki-Ken
ZIP/Postal Code
850-0045
Country
Japan
Facility Name
Gokeikai Osaka Kaisei Hospital Dept of Sleep Medicine
City
Osaka-shi
State/Province
Osaka-Fu
ZIP/Postal Code
532-0003
Country
Japan
Facility Name
Kyowakai Hannan Hospital Dept of Psychiatry
City
Sakai-shi
State/Province
Osaka-Fu
ZIP/Postal Code
599-8263
Country
Japan
Facility Name
Koishikawa Tokyo Hospital Dept of Psychiatry
City
Bunkyo-ku
State/Province
Tokyo-To
ZIP/Postal Code
112-0012
Country
Japan
Facility Name
Nihon University Itabashi Hospital Dept of Neuropsychiatry
City
Itabashi-ku
State/Province
Tokyo-To
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Yoyogi Sleep Disorder Center Dept of Psychiatry
City
Shibuya-ku
State/Province
Tokyo-To
ZIP/Postal Code
151-0053
Country
Japan
Facility Name
Sleep Support Clinic Dept of Psychosomatic Medicine/Psychiatry
City
Shinagawa-ku
State/Province
Tokyo-To
ZIP/Postal Code
140-0011
Country
Japan
Facility Name
Sleep & Stress Clinic Dept of Psychiatry
City
Shinagawa-ku
State/Province
Tokyo-To
ZIP/Postal Code
141-6003
Country
Japan
Facility Name
Sumida Hospital Phase I
City
Sumida-ku
State/Province
Tokyo-To
ZIP/Postal Code
130-0004
Country
Japan
Facility Name
The Catholic University of Korea, St. Vincent's Hospital 300187879
City
Suwon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Hospital 300144594
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Facility Name
Hospital Universitario Araba Sede Santiago Sleep Unit
City
Vitoria
State/Province
Alava
ZIP/Postal Code
01004
Country
Spain
Facility Name
Hospital General de Castellon Servicio de Neurofisiologia
City
Castellon de la Plana
State/Province
Castellon
ZIP/Postal Code
12004
Country
Spain
Facility Name
Hospital Clinic de Barcelona Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Vithas Nuestra Senora de America Neurofisiologia Clinica
City
Madrid
ZIP/Postal Code
28043
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/60659bc6620b3b001e9dbb46
Description
To obtain more information on the study, click here/on this link

Learn more about this trial

A Study of TAK-994 in Adults With Narcolepsy

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