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NCT06812078 · ClinicalTrials.gov registry record · Phase 2
A Study of TAK-360 in Adults With Idiopathic Hypersomnia
A Phase 2 study of Idiopathic Hypersomnia, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
- 20
- Study locations
NCT06812078: Recruiting Phase 2 study of Idiopathic Hypersomnia, sponsored by Takeda.
NCT06812078 is a Phase 2 study of Idiopathic Hypersomnia that is actively recruiting participants, run by Takeda. The registered enrollment target is 96 participants, below the 108-participant average among 7 other Idiopathic Hypersomnia trials with a reported enrollment target (11% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06812078, a Phase 2 study of Idiopathic Hypersomnia, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
- 20
- Study locations
Study Summary
Idiopathic Hypersomnia (IH) is a condition where people feel extremely sleepy during the day, especially in the morning, even if they sleep a lot at night. They may have trouble waking up in the morning, no matter how much they sleep (sometimes more than 11 hours per day), and they can't help feeling tired, even after taking daytime naps. Because of this sleepiness, they may have trouble focusing, thinking clearly, or keeping up with daily activities. They may also have symptoms like dizziness or feeling lightheaded. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake. The main aim of this study is to learn how safe TAK-360 is and how well adults with IH tolerate it. Researchers also want to find out if TAK-360 can help people with IH stay awake and how much TAK-360 is needed to do that. Participants will be randomly (by chance, like drawing names from a hat) chosen to receive either TAK-360 or a placebo. The placebo looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. 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 product.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG TAK-360
Study Locations (20)
California
- Takeda Site 11 - Redwood City
- Takeda Site 10 - Santa Ana
Florida
- Takeda Site 19 - Brandon
- Takeda Site 14 - Winter Park
North Carolina
- Takeda Site 16 - Denver
- Takeda Site 15 - Huntersville
Ohio
- Takeda Site 12 - Cincinnati
- Takeda Site 17 - Cincinnati
Other
- Takeda Site 2 - Paris
- Takeda Site 4 - Shatin
Colorado
- Takeda Site 27 - Colorado Springs
Missouri
- Takeda Site 29 - St Louis
South Carolina
- Takeda Site 13 - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2025-02-07 |
| Est. Completion | 2026-07-16 |
| Phase | Phase 2 |
What NCT06812078 shows while recruiting
NCT06812078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 108-participant average among 7 other Idiopathic Hypersomnia trials with a reported enrollment target (11% lower).
The record links to 1 condition, with Idiopathic Hypersomnia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06812078 names 20 study sites across 15 states, led by California, Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT06812078 about?
NCT06812078 is a clinical study titled "A Study of TAK-360 in Adults With Idiopathic Hypersomnia". Idiopathic Hypersomnia (IH) is a condition where people feel extremely sleepy during the day, especially in the morning, even if they sleep a lot at night. They may have trouble waking up in the morning, no matter how much they sleep (sometimes more than 11 hours per day), and they can't help feelin...
What is the current status of trial NCT06812078?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2025-02-07. Estimated completion is 2026-07-16.
What conditions does trial NCT06812078 study?
This clinical trial studies the following conditions: Idiopathic Hypersomnia.
What interventions are being tested in trial NCT06812078?
The interventions under investigation include: Placebo (OTHER), TAK-360 (DRUG).
Who is sponsoring clinical trial NCT06812078?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06812078 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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