Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of TAK-360 in Adults With Idiopathic Hypersomnia
NCT06812078 · View on ClinicalTrials.gov ↗
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.
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06812078
The ClinicalTrials.gov registry entry for NCT06812078 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06812078 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06812078?
The interventions under investigation include: Placebo (OTHER), TAK-360 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06812078?
This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.