Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial (NCT06505031) enrolled 105 participants — 35 received a placebo and 70 received the investigational medicine oveporexton — to study its effects on narcolepsy symptoms over 12 weeks. The trial measured two main things: how long participants could stay awake during a formal wakefulness test (called the Maintenance of Wakefulness Test, or MWT), and how sleepy they felt day-to-day using a standard questionnaire called the Epworth Sleepiness Scale (ESS, scored 0–24, where higher means sleepier). A number of additional measures were also tracked, including cataplexy episodes (sudden muscle weakness attacks), attention, and overall symptom burden. The reported data shows that, on the main wakefulness test, the placebo group's average time-to-sleep-onset changed by −1.01 minutes from the start of the study, while the oveporexton group's changed by +19.09 minutes (a positive number meaning it took longer to fall asleep). On the sleepiness questionnaire, the placebo group's score changed by −1.57 points and the oveporexton group's by −11.10 points (negative meaning lower sleepiness scores). For cataplexy attacks, the reported estimated average was about 24 attacks per week in the placebo group compared with about 6 per week in the oveporexton group at week 12. On the attention test, the placebo group had 3.36 more lapses on average while the oveporexton group had 5.46 fewer. When asked about their overall impression of change, 15% of the placebo group and 90% of the oveporexton group reported being "much" or "very much" improved. Finally, on a broader narcolepsy symptom scale (scored 0–57, higher meaning worse), the placebo group's score changed by −3.04 points and the oveporexton group's by −21.15 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Narcolepsy Trial, Completed
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 body weight relative to height — falls between 18 and 40.
- 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 guidelines.
- You experience 4 or more episodes of cataplexy (sudden, brief loss of muscle control) per week, whether partial or complete.
- You have tested positive for a specific gene marker (HLA-DQB1*06:02), OR a spinal fluid test has shown very low levels of a brain chemical called orexin/hypocretin (confirm with trial site if unsure which test applies to you).
Who may not be able to join:
- You have another medical condition, besides narcolepsy with cataplexy, that causes excessive daytime sleepiness.
- You have a history of heart attack, significant liver disease, thyroid disease, coronary artery disease, irregular heart rhythm, heart failure, or any unstable condition affecting the heart, lungs, kidneys, or digestive system.
- You have had a stomach or digestive condition within the last 6 months that could affect how your body absorbs medication.
- You have been diagnosed with cancer within the last 5 years.
- You have a significant history of head injury or head trauma.
- You have a history of epilepsy, seizures, or convulsions.
- You currently have an unstable psychiatric condition, or have experienced a major depressive episode either currently or within the past 6 months.
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: Medical Director, Takeda
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
Change From Baseline to Week 12 in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) Wake Trials; Change From Baseline to Week 12 in ESS Total Score
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.