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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: Recruiting Phase 2 study of Narcolepsy Type 1, sponsored by Takeda.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
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 |
What NCT05816382 shows while recruiting
NCT05816382 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 109-participant average among 6 other Narcolepsy Type 1 trials with a reported enrollment target (359% higher).
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 names 20 study sites across 13 states, led by 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.
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