Plain-English translation of NCT05816382 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This is a long-term safety study of , a new medication being tested to treat narcolepsy type 1—a condition that causes extreme daytime sleepiness and sudden loss of muscle control (called cataplexy). This trial will follow people who have already completed earlier studies of this medication to see how safe it is and whether it continues to help reduce their symptoms over a longer period of time.
Narcolepsy type 1 is a serious condition that significantly affects people's daily lives, and doctors need to understand whether this medication remains safe and effective when people take it for many months or years. This study will provide that important long-term information.
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If you join, you will take the medication regularly over approximately 5 years, with the dose adjusted as needed based on how well it works for you. You will visit the clinic multiple times throughout the study (some visits may be conducted from your home), and your doctor will monitor your symptoms, check your overall health, and watch for any side effects. After your last dose, you'll have a follow-up visit about 4 weeks later.
AI-generated summary from trial data · Sep 24, 2026 · Not medical advice
United States