Phase 3 Narcolepsy Trial, Recruiting
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 have been diagnosed with Narcolepsy Type 1 (a sleep disorder causing excessive daytime sleepiness and muscle weakness triggered by emotions) and have already completed a controlled study using the drug TAK-861
- Your doctor who is overseeing the study has no medical concerns about you continuing into this next phase of the trial
Who may not be able to join:
- You experienced a serious side effect during the previous TAK-861 study that has not gone away, or you had to stop the previous study early because of side effects
- You are currently having thoughts of suicide or self-harm, based on answers to a standard safety questionnaire (confirm with trial site)
- Your recent blood tests show that certain liver enzyme levels (ALT and AST) are higher than the normal healthy range
- You have a medical condition other than narcolepsy that also causes excessive daytime sleepiness
- You are currently experiencing, or have experienced in the last 6 months, a major depressive episode (a period of severe, lasting low mood)
- You have developed a stomach or digestive condition in the last 6 months that could affect how your body absorbs medication
- You have epilepsy or have ever had a seizure
- You have any other medical condition — such as anxiety, depression, heart disease, or significant liver, lung, or kidney disease — that requires you to take medications that are not allowed in this trial
- You have a history of a stroke, mini-stroke (within the last 5 years), or bleeding in the brain
- You have a history of a heart attack, significant heart disease, significant chest pain, significant irregular heart rhythm, or heart failure
- You have been diagnosed with cancer within the last 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.
Contact this trial
Principal Investigator: Study Director, Takeda
Phone: +1-877-825-3327
Australian sites
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
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs)
Can't join this trial?
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.