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NCT05687916 · ClinicalTrials.gov registry record · Phase 2
A Study of TAK-861 in Participants With Narcolepsy Type 2
A Phase 2 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
NCT05687916: Completed Phase 2 study, sponsored by Takeda.
NCT05687916 is a Phase 2 study that has completed, run by Takeda. The registered enrollment target is 71 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05687916, a Phase 2 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
Study Summary
The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT). The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups (20 per group) to take one of two different doses of TAK-861 or a placebo. All the participants will receive the treatment for 8 weeks. Participants will be asked to complete some questionnaires during the study. This trial will be conducted in North America, Europe, and Asia Pacific.
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
Interventions
- DRUG Placebo
- DRUG TAK-861 2 mg
- DRUG TAK-861 2 mg and 5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2023-01-09 |
| Est. Completion | 2023-12-25 |
| Phase | Phase 2 |
What the finished NCT05687916 record still lists
NCT05687916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05687916 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05687916 about?
NCT05687916 is a clinical study titled "A Study of TAK-861 in Participants With Narcolepsy Type 2". The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT). The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups (...
What is the current status of trial NCT05687916?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2023-01-09. Estimated completion is 2023-12-25.
What interventions are being tested in trial NCT05687916?
The interventions under investigation include: Placebo (DRUG), TAK-861 2 mg (DRUG), TAK-861 2 mg and 5 mg (DRUG).
Who is sponsoring clinical trial NCT05687916?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05687916's enrollment target sits among peer trials
71 936th of 2000 higher than 1,064 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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