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NCT07363720 · ClinicalTrials.gov registry record · Phase 3
A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
A Phase 3 study of Narcolepsy Type 1 (NT1) and Narcolepsy With Cataplexy, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 88
- Enrollment target
- 7
- Study locations
NCT07363720: Recruiting Phase 3 study of Narcolepsy Type 1 (NT1) and Narcolepsy With Cataplexy, sponsored by Takeda.
NCT07363720 is a Phase 3 study of Narcolepsy Type 1 (NT1) and Narcolepsy With Cataplexy that is actively recruiting participants, run by Takeda. The registered enrollment target is 88 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07363720, a Phase 3 study of Narcolepsy Type 1 (NT1) and Narcolepsy With Cataplexy, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 88 participants
- Enrollment target
- 7
- Study locations
Study Summary
The main aim of this study is to assess how effective TAK-861 is for treating narcolepsy type 1 and if this effect is maintained over time. Participants will take TAK-861 for a few months and if they meet certain criteria, they will be randomly assigned (by chance, like flipping a coin) to continue taking TAK-861 or take placebo (fake medicine) for up to 4 weeks to see if their narcolepsy symptoms return.
Primary Outcome
The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within normal range.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TAK-861
Study Locations (7)
Florida
- Takeda Site 4 - Brandon
- Takeda Site 6 - Miami
California
- Takeda Site 1 - Redwood City
Michigan
- Takeda Site 7 - Southfield
Ohio
- Takeda Site 2 - Cincinnati
South Carolina
- Takeda Site 3 - Columbia
Texas
- Takeda Site 5 - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2026-01-29 |
| Est. Completion | 2026-10-02 |
| Phase | Phase 3 |
What NCT07363720 shows while recruiting
NCT07363720 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Narcolepsy Type 1 (NT1) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07363720 lists 7 locations in 6 states (Florida, California, Michigan).
Frequently Asked Questions
What is clinical trial NCT07363720 about?
NCT07363720 is a clinical study titled "A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy". The main aim of this study is to assess how effective TAK-861 is for treating narcolepsy type 1 and if this effect is maintained over time. Participants will take TAK-861 for a few months and if they meet certain criteria, they will be randomly assigned (by chance, like flipping a coin) to continue ...
What is the current status of trial NCT07363720?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 88 participants. The study started on 2026-01-29. Estimated completion is 2026-10-02.
What conditions does trial NCT07363720 study?
This clinical trial studies the following conditions: Narcolepsy Type 1 (NT1), Narcolepsy With Cataplexy.
What interventions are being tested in trial NCT07363720?
The interventions under investigation include: Placebo (DRUG), TAK-861 (DRUG).
Who is sponsoring clinical trial NCT07363720?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07363720 being conducted?
This trial has 7 study locations across California, Florida, Michigan, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07363720's enrollment target sits among peer trials
88 1740th of 2000 higher than 259 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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