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NCT05687903 · ClinicalTrials.gov registry record · Phase 2
A Study of TAK-861 in Participants With Narcolepsy Type 1
A Phase 2 study of Narcolepsy Type 1, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 112
- Enrollment target
- 20
- Study locations
NCT05687903: Completed Phase 2 study of Narcolepsy Type 1, sponsored by Takeda.
NCT05687903 is a Phase 2 study of Narcolepsy Type 1 that has completed, run by Takeda. The registered enrollment target is 112 participants, below the 174-participant average among 6 other Narcolepsy Type 1 trials with a reported enrollment target (36% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05687903, a Phase 2 study of Narcolepsy Type 1, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 112 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in the study across North America, Europe and Asia Pacific. The treatment (TAK-861 or placebo) will be administered for 8 or 12 weeks. After this treatment period the participant will have the option to participate in a separate, long- term extension study during which all participants will be treated with TAK-861.
Primary Outcome
The MWT is a validated, objective measure that evaluates a participant's ability to remain awake under soporific conditions for a defined period. During each MWT session (1 session = 40 minutes), participants were instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session was recorded on EEG. If no sleep was observed according to these rules, then the latency was defined as 40 minutes. The linear mixed effects model for repeated measures (MMRM) was used for
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TAK-861
Study Locations (20)
Ohio
- 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
Texas
- Comprehensive Sleep Medicine Associates - Sugar Land - Houston
- Sleep Therapy and Research Center - San Antonio
Alabama
- Sleep Disorders Center of Alabama - Birmingham
Colorado
- Delta Waves LLC - Hunt - PPDS, Sleep Disorder and Research Center - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2023-01-09 |
| Est. Completion | 2023-12-14 |
| Phase | Phase 2 |
What the finished NCT05687903 record still lists
NCT05687903 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 174-participant average among 6 other Narcolepsy Type 1 trials with a reported enrollment target (36% lower).
The record links to 1 condition, with Narcolepsy Type 1 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05687903 names 20 study sites across 13 states, led by Ohio, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT05687903 about?
NCT05687903 is a clinical study titled "A Study of TAK-861 in Participants With Narcolepsy Type 1". The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in the study across North America, Europe and Asia Pacific. The treatment (TAK-861 or placebo) will be administered f...
What is the current status of trial NCT05687903?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2023-01-09. Estimated completion is 2023-12-14.
What conditions does trial NCT05687903 study?
This clinical trial studies the following conditions: Narcolepsy Type 1.
What interventions are being tested in trial NCT05687903?
The interventions under investigation include: Placebo (DRUG), TAK-861 (DRUG).
Who is sponsoring clinical trial NCT05687903?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05687903 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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