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A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)
NCT06952699 · View on ClinicalTrials.gov ↗
Study Summary
Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. They may have difficulty thinking clearly, paying attention, or remembering things, during the day. These symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. 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 NT2 tolerate it. Researchers also want to find out if TAK-360 can help people with NT2 stay awake and determine the right dosage needed to do that. Participants will be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo in the treatment period. The placebo is a pill that 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 14 — Redwood City
- Takeda Site 10 — Santa Ana
Florida
- Takeda Site 13 — Brandon
- Takeda Site 3 — Orlando
North Carolina
- Takeda Site 8 — Denver
- Takeda Site 6 — Huntersville
Other
- Takeda Site 15 — Paris
- Takeda Site 23 — Bologna
Colorado
- Takeda Site 1 — Colorado Springs
Missouri
- Takeda Site 4 — St Louis
Ohio
- Takeda Site 5 — Cincinnati
South Carolina
- Takeda Site 2 — Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2025-05-06 |
| Est. Completion | 2026-08-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06952699
The ClinicalTrials.gov registry entry for NCT06952699 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 88 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 Narcolepsy Type 2 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: NCT06952699 reports 20 study locations spanning 16 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 NCT06952699 about?
NCT06952699 is a clinical study titled "A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)". Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night...
What is the current status of trial NCT06952699?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2025-05-06. Estimated completion is 2026-08-20.
What conditions does trial NCT06952699 study?
This clinical trial studies the following conditions: Narcolepsy Type 2. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06952699?
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 NCT06952699?
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 NCT06952699 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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