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NCT06470828 · ClinicalTrials.gov registry record · Phase 3
A Study of TAK-861 for the Treatment of Narcolepsy Type 1
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 168
- Enrollment target
NCT06470828: Completed Phase 3 study, sponsored by Takeda.
NCT06470828 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 168 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06470828, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 168 participants
- Enrollment target
Study Summary
The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect TAK-861 has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms, and daily life functions; and to learn about the safety of TAK-861.
Primary Outcome
The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. The MWT consists of four 40-minute sessions (trials) done 2 hours apart. Sleep latency in each session was recorded. Participants were required t
Interventions
- DRUG Placebo
- DRUG TAK-861
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2024-07-02 |
| Est. Completion | 2025-06-03 |
| Phase | Phase 3 |
What the finished NCT06470828 record still lists
NCT06470828 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06470828 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06470828 about?
NCT06470828 is a clinical study titled "A Study of TAK-861 for the Treatment of Narcolepsy Type 1". The main aim of this study is to learn how effective TAK-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or EDS) after 3 months of treatment. Other aims are to learn how effective TAK-861 is in lowering the number of sudden, unexpected attacks of muscle w...
What is the current status of trial NCT06470828?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 168 participants. The study started on 2024-07-02. Estimated completion is 2025-06-03.
What interventions are being tested in trial NCT06470828?
The interventions under investigation include: Placebo (DRUG), TAK-861 (DRUG).
Who is sponsoring clinical trial NCT06470828?
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 NCT06470828's enrollment target sits among peer trials
168 1459th of 2000 higher than 538 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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