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NCT05816382 · ClinicalTrials.gov registry record · Phase 2
A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
A Phase 2 study of Narcolepsy Type 1, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT05816382 is a Phase 2 study of Narcolepsy Type 1 that is actively recruiting participants, run by Takeda. The registered enrollment target is 500 participants, above the 109-participant average among 6 other Narcolepsy Type 1 trials with a reported enrollment target (359% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT05816382, a Phase 2 study of Narcolepsy Type 1, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG TAK-861
Study Locations (20)
Ohio
- CTI Research Center - Cincinnati
- Intrepid Research - Cincinnati
- The Cleveland Clinic Foundation - Cleveland
- Ohio Sleep Medicine Institute - Dublin
California
- Stanford Center for Sleep Sciences and Medicine - Redwood City
- SDS Clinical Trials, Inc. - Santa Ana
Georgia
- Neurotrials Research - Atlanta
- Georgia Neuro Center - Gainesville
North Carolina
- Research Carolina Elite - Denver
- ARSM Research, LLC - Huntersville
South Carolina
- Medical University of South Carolina - PPDS - Charleston
- Bogan Sleep Consultants, LLC - Columbia
Alabama
- Sleep Disorders Center of Alabama - Birmingham
Colorado
- Delta Waves LLC - Hunt - PPDS - Colorado Springs
Florida
- Florida Pediatric Research Institute - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2023-04-05 |
| Est. Completion | 2028-02-28 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05816382
The ClinicalTrials.gov registry entry for NCT05816382 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 109-participant average among 6 other Narcolepsy Type 1 trials with a reported enrollment target (359% higher). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Narcolepsy Type 1 appearing as the primary indexed condition, and to 1 intervention - of which TAK-861 is the first listed.
NCT05816382 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Ohio, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT05816382 about?
NCT05816382 is a clinical study titled "A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions". 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.
What is the current status of trial NCT05816382?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 500 participants. The study started on 2023-04-05. Estimated completion is 2028-02-28.
What conditions does trial NCT05816382 study?
This clinical trial studies the following conditions: Narcolepsy Type 1.
What interventions are being tested in trial NCT05816382?
The interventions under investigation include: TAK-861 (DRUG).
Who is sponsoring clinical trial NCT05816382?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05816382 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.