A Study to Investigate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP441 Compared Wi… (NCT06961266) | Clinical Trial Compass
TerminatedPhase 1
A Study to Investigate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP441 Compared With Placebo in Participants With Narcolepsy Type 1
Stopped: The study was terminated based on a business decision by the Sponsor.
United States6 participantsStarted 2025-05-13
Plain-language summary
Narcolepsy is a sleep disorder in which patients are not able to maintain wakefulness or require treatment to maintain wakefulness during the daytime. Narcolepsy is a lifelong neurologic disease for which no cure has been clinically available. JZP441 is currently being developed for the treatment of narcolepsy type 1 (NT1). This study will assess the safety of efficacy of JZP441 in adult patients with NT1.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Participants are eligible to be included in the study only if all of the following criteria apply:
1. Is 18 to 64 years of age inclusive at the time of signing the informed consent.
2. Has a physician diagnosis of NT1 according to ICSD-3-TR criteria
3. Has an average sleep latency of less than 15 minutes, as documented by the mean of the first 4 trials of the Baseline MWT, as determined by central assessment.
4. Has a minimum body weight of 50 kg for men and 45 kg for women and a BMI within the range 18.0 to 35.0 kg/m\^2 (inclusive).
5. Participant agrees to the following based on sex assigned at birth.
1. Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 90 days after the last dose of study intervention:
* Refrain from donating sperm
* Use contraception /barrier as specified in the protocol
2. Female participants are eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
* Is a woman of non-childbearing potential (WONCBP) OR
* Is a WOCBP and using a contraceptive method that is highly effective during the study intervention period and until completion of the Safety Follow-up Period.
* Male partners of WOCBP are required to use barrier protection, (eg, condoms) during the study intervention period and over the 90-day period after the last dose of study intervention.
• A WOCBP must have a negati…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean sleep latency of the first 4 sessions of the Maintenance of Wakefulness Test
Timeframe: 1, 3, 5, and 7 hours after the first dose of study intervention