A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions
4 other identifiers
interventional
500
12 countries
52
Brief Summary
The main aim is to evaluate the safety and tolerability of TAK-861 in participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2023
Longer than P75 for phase_2
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2023
CompletedStudy Start
First participant enrolled
April 5, 2023
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2028
March 5, 2026
March 1, 2026
4.9 years
March 31, 2023
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs)
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 (e.g., 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 adverse event with an onset that occurs after receiving trial intervention.
From signing the informed consent form up to follow-up of 4 weeks after the last dose (Up to approximately 5 years)
Secondary Outcomes (3)
Change from Baseline in the Parent Trial in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)
Baseline (parent trial), Week 26 (current LTE trial)
Change from Baseline in the Parent Trial in Epworth Sleepiness Scale (ESS) Total Score
Baseline (parent trial); Week 2 through Year 5 (current LTE trial)
Change from Baseline in the Parent Trial in Weekly Cataplexy Rate (WCR) Using the Patient-reported Cataplexy Diary
Baseline (parent trial); Year 1 through Year 5 (current LTE trial)
Study Arms (1)
TAK-861
EXPERIMENTALIn this trial, all participants are on TAK-861 treatment and they can switch to one of the available doses as needed.
Interventions
Eligibility Criteria
You may qualify if:
- \. Participant with a diagnosis of NT1 who has completed a controlled trial with TAK-861, and for whom the investigator has no clinical objection to their enrollment.
You may not qualify if:
- Participant has a treatment-emergent adverse event (TEAE) that remains severe at the time of rollover related to the trial intervention from the parent trial or discontinued because of TEAEs in the parent trial.
- Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
- The participant has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values greater than (\>) 1.5 times the upper limit of normal (ULN).
- Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).
- Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months.
- Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
- Participant has epilepsy or history of seizure.
- Participant has any other medical condition, such as anxiety, depression, heart disease, or significant hepatic, pulmonary, or renal disease, that requires them to take excluded medications.
- Participant has a history of cerebral ischemia, transient ischemic attack (less than (\<) 5 years ago), or cerebral hemorrhage.
- Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
- Participant has a history of cancer in the past 5 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (52)
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213, United States
Stanford Center for Sleep Sciences and Medicine
Redwood City, California, 94063, United States
SDS Clinical Trials, Inc.
Santa Ana, California, 92705, United States
Delta Waves LLC - Hunt - PPDS
Colorado Springs, Colorado, 80918, United States
Florida Pediatric Research Institute
Orlando, Florida, 32803, United States
Neurotrials Research
Atlanta, Georgia, 30342, United States
Georgia Neuro Center
Gainesville, Georgia, 30501, United States
Neurocare Inc
Newton, Massachusetts, 02459, United States
Henry Ford Medical Center - Columbus
Novi, Michigan, 48377, United States
Research Carolina Elite
Denver, North Carolina, 28037, United States
ARSM Research, LLC
Huntersville, North Carolina, 28078, United States
CTI Research Center
Cincinnati, Ohio, 45212, United States
Intrepid Research
Cincinnati, Ohio, 45227, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017, United States
Medical University of South Carolina - PPDS
Charleston, South Carolina, 29425, United States
Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201, United States
Sleep Therapy and Research Center
San Antonio, Texas, 78229, United States
Children's Specialty Group
Norfolk, Virginia, 23510, United States
Woolcock Institute of Medical Research
Glebe, New South Wales, 2037, Australia
Terveystalo Helsinki Sleep Clinic
Helsinki, Uusimaa, 00380, Finland
Hopital Pierre-Paul Riquet
Toulouse, Haute-Garonne, 31000, France
CHU Gui De Chauliac
Montpellier, Herault, 34090, France
CHU de Grenoble
La Tronche, Isere, 38700, France
Hopital de la Pitie Salpetriere
Paris, 75013, France
Universitaet Regensburg am Bezirksklinikum
Regensburg, Bavaria, 93053, Germany
Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, Mecklenburg-Vorpommern, 19053, Germany
Charite - Universitatsmedizin Berlin
Berlin, 10117, Germany
Klinische Forschung Hamburg
Hamburg, 20253, Germany
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio, 00133, Italy
Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Molise, 86077, Italy
Ospedale Bellaria
Bellaria, 40139, Italy
Kurume University Hospital
Kurume-Shi, Hukuoka, 830-0011, Japan
Howakai Kuwamizu Hospital
Kumamoto, Kumamoto, 862-0954, Japan
YOU ARIYOSHI Sleep Clinic
Nagasaki, Nagasaki, 850-0045, Japan
Gokeikai Osaka Kaisei Hospital
Osaka, Osaka, 532-0003, Japan
Koishikawa Tokyo Hospital
Bunkyo-Ku, Tokyo, 112-0012, Japan
Aichi Medical University Hospital
Nagakute, 480-1195, Japan
Kempenhaeghe - PPDS
Heeze, North Brabant, 5591 VE, Netherlands
Slaap-Waakcentrum SEIN Heemstede
Heemstede, North Holland, 2103 SW, Netherlands
University of Oslo
Oslo, 0450, Norway
Hospital Universitario Araba Santiago
Vitoria-Gasteiz, Alava, 01009, Spain
Hospital General de Castello
Castellon, Castellon, 12004, Spain
Hospital de La Ribera
Alzira, Valencia, 46600, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Instituto de Investigaciones del Sueno
Madrid, 28036, Spain
Hospital Vithas Madrid Arturo Soria
Madrid, 28046, Spain
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 413 46, Sweden
Klinik Barmelweid AG
Barmelweid, Aargau (de), 5017, Switzerland
Neurocenter of Southern Switzerland
Lugano, Ticino (it), 6900, Switzerland
Universitaetsspital Bern - Inselspital
Bern, 43017-3521, Switzerland
Related Links
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Masking Details
- All participants in this long term, dose blinded study received study drug.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2023
First Posted
April 18, 2023
Study Start
April 5, 2023
Primary Completion (Estimated)
February 28, 2028
Study Completion (Estimated)
February 28, 2028
Last Updated
March 5, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, 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.
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.