A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions

ClinicalTrials.gov ID: NCT05816382

Public ClinicalTrials.gov record NCT05816382. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Apr 29, 2026, 9:44 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions

Study identification

NCT ID: NCT05816382
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: Takeda; Industry
Enrollment: 500 participants

Conditions and interventions

Conditions

Narcolepsy Type 1

Interventions

TAK-861 Drug

Drug

Eligibility (public fields only)

Age range: 16 Years to 70 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 4, 2023
Primary completion: Feb 27, 2028
Completion: Feb 27, 2028
Last update posted: Mar 4, 2026

2023 – 2028

United States locations

U.S. sites: 19
U.S. states: 12
U.S. cities: 18

Facility	City	State	ZIP	Site status
Sleep Disorders Center of Alabama	Birmingham	Alabama	35213	Recruiting
Stanford Center for Sleep Sciences and Medicine	Redwood City	California	94063	Recruiting
SDS Clinical Trials, Inc.	Santa Ana	California	92705	Recruiting
Delta Waves LLC - Hunt - PPDS	Colorado Springs	Colorado	80918	Recruiting
Florida Pediatric Research Institute	Orlando	Florida	32803	Recruiting
Neurotrials Research	Atlanta	Georgia	30342	Recruiting
Georgia Neuro Center	Gainesville	Georgia	30501	Recruiting
Neurocare Inc	Newton	Massachusetts	02459	Recruiting
Henry Ford Medical Center - Columbus	Novi	Michigan	48377	Recruiting
Research Carolina Elite	Denver	North Carolina	28037	Recruiting
ARSM Research, LLC	Huntersville	North Carolina	28078	Recruiting
CTI Research Center	Cincinnati	Ohio	45212	Recruiting
Intrepid Research	Cincinnati	Ohio	45227	Recruiting
The Cleveland Clinic Foundation	Cleveland	Ohio	44195	Recruiting
Ohio Sleep Medicine Institute	Dublin	Ohio	43017	Recruiting
Medical University of South Carolina - PPDS	Charleston	South Carolina	29425	Recruiting
Bogan Sleep Consultants, LLC	Columbia	South Carolina	29201	Recruiting
Sleep Therapy and Research Center	San Antonio	Texas	78229	Recruiting
Children's Specialty Group	Norfolk	Virginia	23510	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05816382, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 4, 2026 · Synced Apr 29, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05816382 live on ClinicalTrials.gov.

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