Actively Recruiting
A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions
Led by Takeda · Updated on 2026-03-05
500
Participants Needed
52
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of TAK-861 in people with narcolepsy type 1 (NT1). This study focuses on participants who have already been exposed to TAK-861 doses in previous clinical trials. The goal is to monitor how TAK-861 affects symptoms such as excessive daytime sleepiness and cataplexy episodes over a long period. All participants in this trial will receive TAK-861 tablets. Those who previously received a placebo will be randomly assigned to one of the TAK-861 dose groups. The study is a long-term extension conducted worldwide and is expected to last approximately five years or until the product is approved or the study is stopped. Participants may switch doses as needed and will attend multiple clinic visits, some of which can be done at home. Throughout the trial, participants will be regularly assessed for safety by tracking any treatment-emergent adverse events. Researchers will also measure changes in sleep latency, sleepiness scores, and cataplexy rates compared to baseline data from earlier trials. Follow-up assessments will take place four weeks after the final dose to monitor ongoing effects and ensure participant safety.
CONDITIONS
Brief Title
A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant with a diagnosis of narcolepsy type 1 who has completed a controlled trial with TAK-861
- Investigator has no clinical objection to their enrollment
You will not qualify if you...
- Participant has a severe treatment-emergent adverse event from the parent trial related to TAK-861 or discontinued due to such events
- Risk of suicide based on Columbia Suicide Severity Rating Scale
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal
- Current medical disorder causing excessive daytime sleepiness other than narcolepsy
- Current active major depressive episode or one within the past 6 months
- Recent gastrointestinal disease affecting drug absorption
- Epilepsy or history of seizures
- Medical conditions requiring excluded medications such as anxiety, depression, heart disease, or significant liver, lung, or kidney disease
- History of cerebral ischemia, transient ischemic attack less than 5 years ago, or cerebral hemorrhage
- History of myocardial infarction, significant coronary artery disease, angina, cardiac rhythm abnormality, or heart failure
- History of cancer within the past 5 years
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 5 years or until the study is stopped or product approval.
Participants receive TAK-861 treatment to evaluate its safety and tolerability for narcolepsy type 1.
Multiple visits to the clinic, some optionally conducted by home health
Duration - 4 weeks
Participants have a follow-up assessment 4 weeks after the last dose of TAK-861 to monitor safety.
1 follow-up visit
Trial Site Locations
Total: 52 locations
1
Sleep Disorders Center of Alabama
Birmingham, Alabama, United States, 35213
Actively Recruiting
2
Stanford Center for Sleep Sciences and Medicine
Redwood City, California, United States, 94063
Actively Recruiting
3
SDS Clinical Trials, Inc.
Santa Ana, California, United States, 92705
Actively Recruiting
4
Delta Waves LLC - Hunt - PPDS
Colorado Springs, Colorado, United States, 80918
Actively Recruiting
5
Florida Pediatric Research Institute
Orlando, Florida, United States, 32803
Actively Recruiting
6
Neurotrials Research
Atlanta, Georgia, United States, 30342
Actively Recruiting
7
Georgia Neuro Center
Gainesville, Georgia, United States, 30501
Actively Recruiting
8
Neurocare Inc
Newton, Massachusetts, United States, 02459
Actively Recruiting
9
Henry Ford Medical Center - Columbus
Novi, Michigan, United States, 48377
Actively Recruiting
10
Research Carolina Elite
Denver, North Carolina, United States, 28037
Actively Recruiting
11
ARSM Research, LLC
Huntersville, North Carolina, United States, 28078
Actively Recruiting
12
CTI Research Center
Cincinnati, Ohio, United States, 45212
Actively Recruiting
13
Intrepid Research
Cincinnati, Ohio, United States, 45227
Actively Recruiting
14
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
15
Ohio Sleep Medicine Institute
Dublin, Ohio, United States, 43017
Actively Recruiting
16
Medical University of South Carolina - PPDS
Charleston, South Carolina, United States, 29425
Actively Recruiting
17
Bogan Sleep Consultants, LLC
Columbia, South Carolina, United States, 29201
Actively Recruiting
18
Sleep Therapy and Research Center
San Antonio, Texas, United States, 78229
Actively Recruiting
19
Children's Specialty Group
Norfolk, Virginia, United States, 23510
Actively Recruiting
20
Woolcock Institute of Medical Research
Glebe, New South Wales, Australia, 2037
Actively Recruiting
21
Terveystalo Helsinki Sleep Clinic
Helsinki, Uusimaa, Finland, 00380
Actively Recruiting
22
Hopital Pierre-Paul Riquet
Toulouse, Haute-Garonne, France, 31000
Actively Recruiting
23
CHU Gui De Chauliac
Montpellier, Herault, France, 34090
Actively Recruiting
24
CHU de Grenoble
La Tronche, Isere, France, 38700
Actively Recruiting
25
Hopital de la Pitie Salpetriere
Paris, France, 75013
Actively Recruiting
26
Universitaet Regensburg am Bezirksklinikum
Regensburg, Bavaria, Germany, 93053
Actively Recruiting
27
Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, Mecklenburg-Vorpommern, Germany, 19053
Actively Recruiting
28
Charite - Universitatsmedizin Berlin
Berlin, Germany, 10117
Actively Recruiting
29
Klinische Forschung Hamburg
Hamburg, Germany, 20253
Actively Recruiting
30
Fondazione PTV Policlinico Tor Vergata
Rome, Lazio, Italy, 00133
Actively Recruiting
31
Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Molise, Italy, 86077
Actively Recruiting
32
Ospedale Bellaria
Bellaria, Italy, 40139
Actively Recruiting
33
Kurume University Hospital
Kurume-Shi, Hukuoka, Japan, 830-0011
Actively Recruiting
34
Howakai Kuwamizu Hospital
Kumamoto, Kumamoto, Japan, 862-0954
Actively Recruiting
35
YOU ARIYOSHI Sleep Clinic
Nagasaki, Nagasaki, Japan, 850-0045
Actively Recruiting
36
Gokeikai Osaka Kaisei Hospital
Osaka, Osaka, Japan, 532-0003
Actively Recruiting
37
Koishikawa Tokyo Hospital
Bunkyo-Ku, Tokyo, Japan, 112-0012
Actively Recruiting
38
Aichi Medical University Hospital
Nagakute, Japan, 480-1195
Actively Recruiting
39
Kempenhaeghe - PPDS
Heeze, North Brabant, Netherlands, 5591 VE
Actively Recruiting
40
Slaap-Waakcentrum SEIN Heemstede
Heemstede, North Holland, Netherlands, 2103 SW
Actively Recruiting
41
University of Oslo
Oslo, Norway, 0450
Actively Recruiting
42
Hospital Universitario Araba Santiago
Vitoria-Gasteiz, Alava, Spain, 01009
Actively Recruiting
43
Hospital General de Castello
Castellon, Castellon, Spain, 12004
Actively Recruiting
44
Hospital de La Ribera
Alzira, Valencia, Spain, 46600
Actively Recruiting
45
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Spain, 08035
Actively Recruiting
46
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
47
Instituto de Investigaciones del Sueno
Madrid, Spain, 28036
Actively Recruiting
48
Hospital Vithas Madrid Arturo Soria
Madrid, Spain, 28046
Actively Recruiting
49
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden, 413 46
Actively Recruiting
50
Klinik Barmelweid AG
Barmelweid, Aargau (de), Switzerland, 5017
Actively Recruiting
51
Neurocenter of Southern Switzerland
Lugano, Ticino (it), Switzerland, 6900
Actively Recruiting
52
Universitaetsspital Bern - Inselspital
Bern, Switzerland, 43017-3521
Actively Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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