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A Study of TAK-861 in Participants With Narcolepsy Type 1

Primary Purpose

Narcolepsy Type 1

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TAK-861
Placebo
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The participant is aged 18 to 70 years, inclusive, at the time of signing the informed consent form (ICF). Note: In Japan, participants aged 16 to 70 years, inclusive, may be included. The participant has body mass index (BMI) within the range 18 to 40 kilogram per square meter [kg/m^2] (inclusive). The participant has an International Classification of Sleep Disorders, 3rd Edition (ICSD-3) diagnosis of narcolepsy type 1 (NT1) by polysomnography (PSG)/Multiple Sleep Latency Test (MSLT), performed within the past 10 years. The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1*06:02 or results from cerebrospinal fluid (CSF) testing indicate the participant's CSF orexin (OX)/hypocretin-1 concentration is <110 picograms per milliliter ([pg/mL] (or less than one-third of the mean values obtained in normal participants within the same standardized assay). Exclusion Criteria: The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS. The participant has medically significant hepatic or thyroid disease. The participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment or basal cell cancer). The participant has clinically significant coronary artery disease, a history of myocardial infarction, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure. The participant has a clinically significant history of head injury or head trauma. The participant has history of epilepsy, seizure, or convulsion, or has a family history of inherited disorders associated with seizure (except for a single febrile seizure in childhood). The participant has one or more of the following psychiatric disorders: Any current unstable psychiatric disorder. Current or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, intellectual disability, organic mental disorders, or mental disorders due to a general medical condition as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Current diagnosis or history of substance use disorder as defined in the DSM-5. Current active major depressive episode (MDE) or who have had an active MDE in the past 6 months. The participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), intracranial aneurysm, or arteriovenous malformation. The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody/antigen. The participant's renal creatinine clearance (Cockcroft-Gault Equation) is ≤50 mL/minute. The participant has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values >1.5 times the upper limit of normal (ULN). The participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within the past year.

Sites / Locations

  • Sleep Disorders Center of AlabamaRecruiting
  • Stanford Center for Sleep Sciences and MedicineRecruiting
  • SDS Clinical Trials, Inc.Recruiting
  • Delta Waves LLC - Hunt - PPDS, Sleep Disorder and Research CenterRecruiting
  • Florida Pediatric Research InstituteRecruiting
  • Neurotrials ResearchRecruiting
  • Georgia Neuro CenterRecruiting
  • University of Kansas Medical Center Research Institute, Inc.Recruiting
  • Neurocare IncRecruiting
  • Henry Ford Medical Center - ColumbusRecruiting
  • St. Lukes Sleep Medicine and Research CenterRecruiting
  • Research Carolina EliteRecruiting
  • ARSM Research, LLCRecruiting
  • Intrepid ResearchRecruiting
  • The Cleveland Clinic FoundationRecruiting
  • Ohio Sleep Medicine InstituteRecruiting
  • Medical University of South Carolina - PPDSRecruiting
  • Bogan Sleep Consultants, LLCRecruiting
  • Comprehensive Sleep Medicine Associates - Sugar LandRecruiting
  • Sleep Therapy and Research CenterRecruiting
  • Children's Specialty GroupRecruiting
  • Woolcock Institute of Medical Research, Sleep and Circadian Research GroupRecruiting
  • Terveystalo Helsinki Sleep ClinicRecruiting
  • Hopital Pierre-Paul RiquetRecruiting
  • CHU Gui De ChauliacRecruiting
  • CHU de GrenobleRecruiting
  • Hopital de la Pitie SalpetriereRecruiting
  • Universitaet Regensburg am BezirksklinikumRecruiting
  • Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbHRecruiting
  • Charite - Universitatsmedizin BerlinRecruiting
  • Klinische Forschung HamburgRecruiting
  • IRCCS Istituto delle Scienze Neurologiche di Bologna, Dipartimento di Scienze Biomediche e NeuromotorieRecruiting
  • Fondazione PTV Policlinico Tor Vergata, Centro del Sonno e del Trattamento Neurologico delle FragiltaRecruiting
  • Istituto Neurologico Mediterraneo Neuromed, Centro Per La Diagnosi E la Cura Del SonnoRecruiting
  • Akita University HospitalRecruiting
  • Kurume University HospitalRecruiting
  • Howakai Kuwamizu Hospital, Chuo-KuRecruiting
  • Gokeikai Osaka Kaisei Hospital, Yodogawa-KuRecruiting
  • Koishikawa Tokyo HospitalRecruiting
  • National Center of Neurology and PsychiatryRecruiting
  • Yoyogi Sleep Disorder CenterRecruiting
  • Aichi Medical University HospitalRecruiting
  • RESM respiratory and sleep medical-care clinic, Yokoharna Building, 4FloorRecruiting
  • Kempenhaeghe - PPDSRecruiting
  • Slaap-Waakcentrum SEIN HeemstedeRecruiting
  • University of OsloRecruiting
  • Hospital Universitario Araba Santiago, Unidad Funcional de SuenoRecruiting
  • Hospital General de Castello, Sleep UnitRecruiting
  • Hospital de La Ribera, Unidad de SuenoRecruiting
  • Hospital Universitario Vall d'Hebron - PPDSRecruiting
  • Hospital Clinic de Barcelona, Neurology Service, scale 8-4th floorRecruiting
  • Instituto de Investigaciones del SuenoRecruiting
  • Hospital Vithas Madrid Arturo SoriaRecruiting
  • Sahlgrenska UniversitetssjukhusetRecruiting
  • Klinik Barmelweid AGRecruiting
  • Neurocenter of Southern SwitzerlandRecruiting
  • Universitaetsspital Bern, Department of NeurologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

TAK-861 Dose 1

TAK-861 Dose 2

TAK-861 Dose 3

TAK-861 Dose 4

Placebo

Arm Description

Participants will receive TAK-861 dose 1, orally, from Day 1 up to Weeks 8 or 12.

Participants will receive TAK-861 dose 2, orally, from Day 1 up to Weeks 8 or 12.

Participants will receive TAK-861 dose 3, orally, from Day 1 up to Weeks 8 or 12.

Participants will receive TAK-861 dose 4, orally, from Day 1 up to Weeks 8 or 12.

Participants will receive TAK-861 matching placebo tablets, orally, from Day 1 up to Weeks 8 or 12.

Outcomes

Primary Outcome Measures

Change from Baseline to Week 8 in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)
The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions done 2 hours apart. Sleep latency in each session will be recorded. Participants will be required to stay awake in between the 4 sessions.

Secondary Outcome Measures

Change from Baseline to Week 8 in Epworth Sleepiness Scale (ESS) Total Score
The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; 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.
Weekly Cataplexy Rate at Week 8
Occurrence of at Least One Related Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.

Full Information

First Posted
January 9, 2023
Last Updated
August 10, 2023
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT05687903
Brief Title
A Study of TAK-861 in Participants With Narcolepsy Type 1
Official Title
A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
May 29, 2024 (Anticipated)
Study Completion Date
May 29, 2024 (Anticipated)

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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in the study across North America, Europe and Asia Pacific. The treatment (TAK-861 or placebo) will be administered for 8 or 12 weeks. After this treatment period the participant will have the option to participate in a separate, long- term extension study during which all participants will be treated with TAK-861.
Detailed Description
The drug being tested in this study is called TAK-861. This study will look at the effect of TAK-861 on improvement in narcolepsy symptoms, including excessive daytime sleepiness (EDS) and number of cataplexy episodes. The study will enroll approximately 100 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the five treatment groups which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): TAK-861 Dose 1 TAK-861 Dose 2 TAK-861 Dose 3 TAK-861 Dose 4 Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 23 weeks. Participants will make multiple visits to the clinic during the treatment period and then will either enroll in a long-term extension study in which all participants will receive TAK-861 or have 2 final visits 7 and 28 days after last dose of study drug for follow-up assessments.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAK-861 Dose 1
Arm Type
Experimental
Arm Description
Participants will receive TAK-861 dose 1, orally, from Day 1 up to Weeks 8 or 12.
Arm Title
TAK-861 Dose 2
Arm Type
Experimental
Arm Description
Participants will receive TAK-861 dose 2, orally, from Day 1 up to Weeks 8 or 12.
Arm Title
TAK-861 Dose 3
Arm Type
Experimental
Arm Description
Participants will receive TAK-861 dose 3, orally, from Day 1 up to Weeks 8 or 12.
Arm Title
TAK-861 Dose 4
Arm Type
Experimental
Arm Description
Participants will receive TAK-861 dose 4, orally, from Day 1 up to Weeks 8 or 12.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive TAK-861 matching placebo tablets, orally, from Day 1 up to Weeks 8 or 12.
Intervention Type
Drug
Intervention Name(s)
TAK-861
Intervention Description
TAK-861 tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
TAK-861 placebo matching tablets
Primary Outcome Measure Information:
Title
Change from Baseline to Week 8 in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)
Description
The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions done 2 hours apart. Sleep latency in each session will be recorded. Participants will be required to stay awake in between the 4 sessions.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Change from Baseline to Week 8 in Epworth Sleepiness Scale (ESS) Total Score
Description
The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; 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.
Time Frame
Baseline, Week 8
Title
Weekly Cataplexy Rate at Week 8
Time Frame
Week 8
Title
Occurrence of at Least One Related Treatment-emergent Adverse Event (TEAE)
Description
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.
Time Frame
Baseline up to approximately 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participant is aged 18 to 70 years, inclusive, at the time of signing the informed consent form (ICF). Note: In Japan, participants aged 16 to 70 years, inclusive, may be included. The participant has body mass index (BMI) within the range 18 to 40 kilogram per square meter [kg/m^2] (inclusive). The participant has an International Classification of Sleep Disorders, 3rd Edition (ICSD-3) diagnosis of narcolepsy type 1 (NT1) by polysomnography (PSG)/Multiple Sleep Latency Test (MSLT), performed within the past 10 years. The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1*06:02 or results from cerebrospinal fluid (CSF) testing indicate the participant's CSF orexin (OX)/hypocretin-1 concentration is <110 picograms per milliliter ([pg/mL] (or less than one-third of the mean values obtained in normal participants within the same standardized assay). Exclusion Criteria: The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS. The participant has medically significant hepatic or thyroid disease. The participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment or basal cell cancer). The participant has clinically significant coronary artery disease, a history of myocardial infarction, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure. The participant has a clinically significant history of head injury or head trauma. The participant has history of epilepsy, seizure, or convulsion, or has a family history of inherited disorders associated with seizure (except for a single febrile seizure in childhood). The participant has one or more of the following psychiatric disorders: Any current unstable psychiatric disorder. Current or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, intellectual disability, organic mental disorders, or mental disorders due to a general medical condition as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Current diagnosis or history of substance use disorder as defined in the DSM-5. Current active major depressive episode (MDE) or who have had an active MDE in the past 6 months. The participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), intracranial aneurysm, or arteriovenous malformation. The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody/antigen. The participant's renal creatinine clearance (Cockcroft-Gault Equation) is ≤50 mL/minute. The participant has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values >1.5 times the upper limit of normal (ULN). The participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within the past year.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeda Contact
Phone
+1-877-825-3327
Email
medinfoUS@takeda.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Sleep Disorders Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213-1966
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford Center for Sleep Sciences and Medicine
City
Redwood City
State/Province
California
ZIP/Postal Code
94063-3132
Country
United States
Individual Site Status
Recruiting
Facility Name
SDS Clinical Trials, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705-8519
Country
United States
Individual Site Status
Recruiting
Facility Name
Delta Waves LLC - Hunt - PPDS, Sleep Disorder and Research Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Pediatric Research Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803-1468
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurotrials Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1743
Country
United States
Individual Site Status
Recruiting
Facility Name
Georgia Neuro Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501-3883
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Medical Center Research Institute, Inc.
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-0001
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurocare Inc
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459-3233
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Medical Center - Columbus
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Lukes Sleep Medicine and Research Center
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017-3406
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Carolina Elite
City
Denver
State/Province
North Carolina
ZIP/Postal Code
28037
Country
United States
Individual Site Status
Recruiting
Facility Name
ARSM Research, LLC
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078-5082
Country
United States
Individual Site Status
Recruiting
Facility Name
Intrepid Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227-2172
Country
United States
Individual Site Status
Recruiting
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-0001
Country
United States
Individual Site Status
Recruiting
Facility Name
Ohio Sleep Medicine Institute
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017-3521
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina - PPDS
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-5712
Country
United States
Individual Site Status
Recruiting
Facility Name
Bogan Sleep Consultants, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201-2923
Country
United States
Individual Site Status
Recruiting
Facility Name
Comprehensive Sleep Medicine Associates - Sugar Land
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2042
Country
United States
Individual Site Status
Recruiting
Facility Name
Sleep Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-4849
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Specialty Group
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510-1021
Country
United States
Individual Site Status
Recruiting
Facility Name
Woolcock Institute of Medical Research, Sleep and Circadian Research Group
City
Glebe
State/Province
New South Wales
ZIP/Postal Code
2037
Country
Australia
Individual Site Status
Recruiting
Facility Name
Terveystalo Helsinki Sleep Clinic
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00380
Country
Finland
Individual Site Status
Recruiting
Facility Name
Hopital Pierre-Paul Riquet
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Gui De Chauliac
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34090
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Grenoble
City
La Tronche
State/Province
Isere
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital de la Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
Universitaet Regensburg am Bezirksklinikum
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Name
Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19053
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charite - Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinische Forschung Hamburg
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Individual Site Status
Recruiting
Facility Name
IRCCS Istituto delle Scienze Neurologiche di Bologna, Dipartimento di Scienze Biomediche e Neuromotorie
City
Bellaria
State/Province
Bologna
ZIP/Postal Code
40139
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione PTV Policlinico Tor Vergata, Centro del Sonno e del Trattamento Neurologico delle Fragilta
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Neurologico Mediterraneo Neuromed, Centro Per La Diagnosi E la Cura Del Sonno
City
Pozzilli
State/Province
Molise
ZIP/Postal Code
86077
Country
Italy
Individual Site Status
Recruiting
Facility Name
Akita University Hospital
City
Akita-Shi
State/Province
Akita
ZIP/Postal Code
010-8543
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kurume University Hospital
City
Kurume-Shi
State/Province
Hukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Howakai Kuwamizu Hospital, Chuo-Ku
City
Kumamoto-Shi
State/Province
Kumamoto
ZIP/Postal Code
862-0954
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gokeikai Osaka Kaisei Hospital, Yodogawa-Ku
City
Osaka-Shi
State/Province
Osaka
ZIP/Postal Code
532-0003
Country
Japan
Individual Site Status
Recruiting
Facility Name
Koishikawa Tokyo Hospital
City
Bunkyo-Ku
State/Province
Tokyo
ZIP/Postal Code
112-0012
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Center of Neurology and Psychiatry
City
Kodaira-Shi
State/Province
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yoyogi Sleep Disorder Center
City
Shibuya-Ku
State/Province
Tokyo
ZIP/Postal Code
151-0053
Country
Japan
Individual Site Status
Recruiting
Facility Name
Aichi Medical University Hospital
City
Nagakute
ZIP/Postal Code
480-1195
Country
Japan
Individual Site Status
Recruiting
Facility Name
RESM respiratory and sleep medical-care clinic, Yokoharna Building, 4Floor
City
Yokohama
ZIP/Postal Code
222-0033
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kempenhaeghe - PPDS
City
Heeze
State/Province
Noord-Brabant
ZIP/Postal Code
5591 VE
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Slaap-Waakcentrum SEIN Heemstede
City
Heemstede
State/Province
Noord-Holland
ZIP/Postal Code
2103 SW
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
University of Oslo
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Araba Santiago, Unidad Funcional de Sueno
City
Vitoria
State/Province
Alava
ZIP/Postal Code
01004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General de Castello, Sleep Unit
City
Castellón De La Plana
State/Province
Castellon
ZIP/Postal Code
12004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de La Ribera, Unidad de Sueno
City
Alzira
State/Province
Valencia
ZIP/Postal Code
46600
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebron - PPDS
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic de Barcelona, Neurology Service, scale 8-4th floor
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Instituto de Investigaciones del Sueno
City
Madrid
ZIP/Postal Code
28036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Vithas Madrid Arturo Soria
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Sahlgrenska Universitetssjukhuset
City
Goteborg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 46
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Klinik Barmelweid AG
City
Barmelweid
State/Province
Aargau (de)
ZIP/Postal Code
5017
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Neurocenter of Southern Switzerland
City
Lugano
State/Province
Ticino (it)
ZIP/Postal Code
6900
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Universitaetsspital Bern, Department of Neurology
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting

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/4c5a5e765b46449e?idFilter=%5B%22TAK-861-2001%22%5D
Description
To obtain more information on the study, click here/on this link

Learn more about this trial

A Study of TAK-861 in Participants With Narcolepsy Type 1

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