Phase 2 Narcolepsy Trial, Recruiting NCT07633301 Sponsor: Takeda Condition: Narcolepsy
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Phase 2 Narcolepsy Trial, Recruiting

NCT07633301
Recruiting Phase 2 🇦🇺 Australian site

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:

  • Your body mass index (BMI — a measure of weight relative to height) is between 18 and 40 (inclusive).
  • You have been officially diagnosed with Narcolepsy Type 1 (a sleep disorder that causes extreme daytime sleepiness and sudden muscle weakness) according to recognised medical diagnostic guidelines.

Who may not be able to join:

  • You have a medical condition other than narcolepsy with cataplexy that also causes extreme daytime sleepiness.
  • You have a history of heart attack, significant thyroid problems, coronary artery disease, irregular heart rhythm, or heart failure.
  • You have a significant history of head injury or head trauma.
  • You have a history of epilepsy, seizures, or convulsions (except for a single fever-related seizure during childhood).
  • You have a history of a stroke, a mini-stroke within the last 5 years, a brain aneurysm, or an abnormal connection between blood vessels in the brain.
  • You have been diagnosed with cancer in the past 5 years (some exceptions may apply — confirm with trial site).
  • Your blood tests at screening show a positive result for Hepatitis B, Hepatitis C, or HIV.
  • You are currently taking part in, or plan to join, another clinical trial at the same time, or you have previously taken part in another part of this same trial.
  • You have a known allergy or sensitivity to any ingredient in the study drug TAK-360 or similar compounds.

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 2: approximately ~30% 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: Study Director, Takeda

Phone: +1-877-825-3327

Australian sites

Takeda Site 2, Macquarie Park, New South Wales

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 2
Sponsor
Registry
ClinicalTrials.gov
Start date
4 June 2026
Est. completion
28 November 2027

Where this trial is recruiting

🇦🇺 Australia 🇨🇳 China 🇫🇷 France 🇮🇹 Italy 🇯🇵 Japan 🇪🇸 Spain 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Parts A, B and C: Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)

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