Back to resultsA Study of TAK-861 in Participants With Narcolepsy Type 2
Primary Purpose
Narcolepsy Type 2
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TAK-861
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Narcolepsy Type 2 focused on measuring Drug Therapy
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 an International Classification of Sleep Disorders, 3rd edition (ICSD-3) diagnosis of NT2 by preceding polysomnography (PSG)/ multiple sleep latency test (MSLT), performed within the past 5 years. Note: If there is a potential participant with NT2 for whom a diagnostic nocturnal polysomnography (nPSG)/MSLT was performed more than 5 years ago or is not available, the site may repeat the diagnostic PSG/MSLT. Exclusion Criteria: The participant has a current medical disorder, other than narcolepsy without cataplexy, associated with EDS. 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, mental retardation, 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. Note: If the history of substance use disorder is more than 12 months before baseline, the participant may be allowed to enroll in the study after consultation with the sponsor or designee. (Participant must also have negative urine drug screen at the screening and Day -2 visit.) 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 had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.
Sites / Locations
- Sleep Disorders Center of AlabamaRecruiting
- Mayo Clinic Arizona-PPDS
- Stanford Center for Sleep Sciences and Medicine
- SDS Clinical Trials, Inc.Recruiting
- Delta Waves LLC - Hunt - PPDSRecruiting
- Florida Pediatric Research InstituteRecruiting
- Neurotrials ResearchRecruiting
- Georgia Neuro CenterRecruiting
- Neurocare Inc.Recruiting
- Henry Ford Medical Center - ColumbusRecruiting
- St. Lukes Sleep Medicine and Research CenterRecruiting
- Research Carolina EliteRecruiting
- ARSM Research, LLCRecruiting
- Tricoastal Narcolepsy and Sleep Disorders Center, PLLCRecruiting
- 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
- Terveystalo Helsinki Sleep ClinicRecruiting
- Hopital Saint-EloiRecruiting
- CHU de GrenobleRecruiting
- Hopital de la Pitie SalpetriereRecruiting
- Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH
- Advanced Sleep Research GmbH
- Fondazione PTV Policlinico Tor VergataRecruiting
- Istituto Neurologico Mediterraneo NeuromedRecruiting
- IRCCS Istituto delle Scienze Neurologiche di BolognaRecruiting
- Akita University HospitalRecruiting
- Ehime University Hospital
- You Ariyoshi Sleep ClinicRecruiting
- Kurume University Hospital
- Howakai Kuwamizu HospitalRecruiting
- Gokeikai Osaka Kaisei Hospital
- Koishikawa Tokyo HospitalRecruiting
- National Center of Neurology and PsychiatryRecruiting
- Yoyogi Sleep Disorder Center
- Aichi Medical University HospitalRecruiting
- RESM respiratory and sleep medical-care clinic
- Kempenhaeghe - PPDSRecruiting
- Slaap-Waakcentrum SEIN HeemstedeRecruiting
- Oslo Universitetssykehus HF RikshospitaletRecruiting
- Hospital Universitario Araba SantiagoRecruiting
- Hospital General Universitari de CastelloRecruiting
- Hospital de La RiberaRecruiting
- Hospital Clinic de BarcelonaRecruiting
- Instituto de Investigaciones del SuenoRecruiting
- Hospital Vithas Madrid Arturo SoriaRecruiting
- Sahlgrenska UniversitetssjukhusetRecruiting
- Klinik Barmelweid AG
- Neurocenter of Southern Switzerland
- Universitaetsspital Bern - Inselspital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
TAK-861 Dose 1
TAK-861 Dose 2
Placebo
Arm Description
TAK-861 dose 1, orally for 8 weeks.
TAK-861 dose 2, orally for 8 weeks.
TAK-861 matching placebo tablets, orally for 8 weeks.
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.
Percentage of Participants who Experience at Least one 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
1. Study Identification
Unique Protocol Identification Number
NCT05687916
Brief Title
A Study of TAK-861 in Participants With Narcolepsy Type 2
Official Title
A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy Without Cataplexy (Narcolepsy Type 2)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
May 17, 2024 (Anticipated)
Study Completion Date
October 5, 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 is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT).
The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups (20 per group) to take one of two different doses of TAK-861 or a placebo. All the participants will receive the treatment for 8 weeks. Participants will be asked to complete some questionnaires during the study. This trial will be conducted in North America, Europe, and Asia Pacific.
Detailed Description
The drug being tested in this study is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy without cataplexy [Narcolepsy Type 2 (NT2)]. This study will evaluate the efficacy, safety, and tolerability of 2 oral doses of TAK-861.
The study will enroll approximately 60 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
TAK-861 Dose 1
TAK-861 Dose 2
Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient
This is a multi-center trial to be conducted worldwide. The overall time to participate in this study is approximately 18 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy Type 2
Keywords
Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAK-861 Dose 1
Arm Type
Experimental
Arm Description
TAK-861 dose 1, orally for 8 weeks.
Arm Title
TAK-861 Dose 2
Arm Type
Experimental
Arm Description
TAK-861 dose 2, orally for 8 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
TAK-861 matching placebo tablets, orally for 8 weeks.
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
Percentage of Participants who Experience at Least one 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
From baseline up to approximately 12 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 an International Classification of Sleep Disorders, 3rd edition (ICSD-3) diagnosis of NT2 by preceding polysomnography (PSG)/ multiple sleep latency test (MSLT), performed within the past 5 years.
Note: If there is a potential participant with NT2 for whom a diagnostic nocturnal polysomnography (nPSG)/MSLT was performed more than 5 years ago or is not available, the site may repeat the diagnostic PSG/MSLT.
Exclusion Criteria:
The participant has a current medical disorder, other than narcolepsy without cataplexy, associated with EDS.
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, mental retardation, 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. Note: If the history of substance use disorder is more than 12 months before baseline, the participant may be allowed to enroll in the study after consultation with the sponsor or designee. (Participant must also have negative urine drug screen at the screening and Day -2 visit.)
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 had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.
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
Mayo Clinic Arizona-PPDS
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5452
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Stanford Center for Sleep Sciences and Medicine
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Not yet 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
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
Neurocare Inc.
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
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
Tricoastal Narcolepsy and Sleep Disorders Center, PLLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
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
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
City
Glebe
State/Province
New South Wales
ZIP/Postal Code
2037
Country
Australia
Individual Site Status
Not yet 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 Saint-Eloi
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
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
Not yet recruiting
Facility Name
Advanced Sleep Research GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Fondazione PTV Policlinico Tor Vergata
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Neurologico Mediterraneo Neuromed
City
Pozzilli
State/Province
Molise
ZIP/Postal Code
86077
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Istituto delle Scienze Neurologiche di Bologna
City
Bellaria
ZIP/Postal Code
40139
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
Ehime University Hospital
City
Toon-Shi
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
You Ariyoshi Sleep Clinic
City
Kitakyushu-city
State/Province
Hukuoka
ZIP/Postal Code
806-0021
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
Not yet recruiting
Facility Name
Howakai Kuwamizu Hospital
City
Kumamoto-Shi
State/Province
Kumamoto
ZIP/Postal Code
862-0954
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gokeikai Osaka Kaisei Hospital
City
Osaka-Shi
State/Province
Osaka
ZIP/Postal Code
532-0003
Country
Japan
Individual Site Status
Not yet 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
Not yet 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
City
Yokohama
ZIP/Postal Code
222-0033
Country
Japan
Individual Site Status
Not yet 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
Oslo Universitetssykehus HF Rikshospitalet
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Araba Santiago
City
Vitoria-Gasteiz
State/Province
Alava
ZIP/Postal Code
1004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitari de Castello
City
Castellón De La Plana
State/Province
Castellon
ZIP/Postal Code
12004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de La Ribera
City
Alzira
State/Province
Valencia
ZIP/Postal Code
46600
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic de Barcelona
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
28043
Country
Spain
Individual Site Status
Recruiting
Facility Name
Sahlgrenska Universitetssjukhuset
City
Goteborg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 90
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
Not yet recruiting
Facility Name
Neurocenter of Southern Switzerland
City
Lugano
State/Province
Ticino (it)
ZIP/Postal Code
6900
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsspital Bern - Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Not yet 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/b8004ec7e72e4dd0?idFilter=%5B%22TAK-861-2002%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 2
We'll reach out to this number within 24 hrs