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NCT07633301 · ClinicalTrials.gov registry record · Phase 2
A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)
A Phase 2 study, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
NCT07633301: Recruiting Phase 2 study, sponsored by Takeda.
NCT07633301 is a Phase 2 study that is actively recruiting participants, run by Takeda. The registered enrollment target is 92 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07633301, a Phase 2 study, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
Study Summary
Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness \[EDS\]), where a person may fall asleep without warning. Narcolepsy Type 1 (NT1) is a form of the condition in which people also have sudden, unexpected muscle weakness while staying conscious (called cataplexy). The main aim of this study is to learn how safe TAK-360 is and how well adults with NT1 tolerate it. Adults who can participate in the study will have to stop taking their existing medicines for NT1 before study treatment starts. Participants may be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo during the treatment period. The placebo looks just like TAK-360 but does not have any medicine in it. After the treatment period, participants can be monitored for another 2 weeks. Participants can restart their usual NT1 treatment after study treatment ends. The participants will have to visit the clinic multiple times during this study.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal p
Interventions
- DRUG Placebo
- DRUG TAK-360
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2026-06-04 |
| Est. Completion | 2027-11-28 |
| Phase | Phase 2 |
What NCT07633301 shows while recruiting
NCT07633301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07633301 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07633301 about?
NCT07633301 is a clinical study titled "A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)". Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness \[EDS\]), where a person may fall asleep without warning. Narcolepsy Type 1 (NT1) is a form of the condition in which people also have su...
What is the current status of trial NCT07633301?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2026-06-04. Estimated completion is 2027-11-28.
What interventions are being tested in trial NCT07633301?
The interventions under investigation include: Placebo (DRUG), TAK-360 (DRUG).
Who is sponsoring clinical trial NCT07633301?
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 NCT07633301's enrollment target sits among peer trials
92 767th of 2000 higher than 1,230 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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