Phase 3 Narcolepsy Trial, Recruiting NCT07646678 Sponsor: Takeda Condition: Narcolepsy
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Phase 3 Narcolepsy Trial, Recruiting

NCT07646678
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are willing and able to understand and follow all the steps and requirements of the trial.
  • You have been diagnosed with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH), and you have already completed the treatment period in a related previous TAK-360 trial.
  • You have signed and dated a consent form agreeing to take part before any trial procedures begin.

Who may not be able to join:

  • You are pregnant (based on a positive pregnancy test) or are currently breastfeeding.
  • You have shown signs of being at risk of suicide, based on specific questions from a standard assessment tool called the Columbia Suicide Severity Rating Scale (confirm with trial site).
  • You have developed a new medical condition that causes excessive daytime sleepiness.
  • You have developed a stomach or digestive system disease in the last 6 months that could affect how your body absorbs medication.
  • You have developed a new history of seizures.
  • You have had a significant head injury, as judged by the trial doctor.
  • You have developed a history of stroke, a mini-stroke (within the last 5 years), or bleeding in the brain.
  • You have developed a history of heart attack, significant heart or coronary artery disease, significant chest pain (angina), significant irregular heart rhythm, or heart failure.
  • You have been diagnosed with a significant thyroid condition, known liver problems, or another serious long-term medical condition beyond your sleep disorder.
  • You have had a cancer diagnosis in the past 5 years.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Takeda Contact, Takeda

Phone: +1-877-825-3327

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
11 June 2026
Est. completion
15 June 2031

Where this trial is recruiting

🇯🇵 Japan

Primary endpoints

Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov