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NCT07625280Possibly a fitRecruiting

Twice-nightly treatment for narcolepsy or idiopathic hypersomnia

NarcolepsyIdiopathic Hypersomnia

Part of Brain & nervous system, Mental health clinical trials.

This study tests whether taking the sleep medicine Xywav two times each night is safe and helps control symptoms better than a placebo. People with narcolepsy or idiopathic hypersomnia may join, including those who have not tried oxybate medicines before.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
120 people
Ages
18 years to 75 years
Study type
Interventional

Who can take part

  • Diagnosed with narcolepsy (type 1 or 2) or idiopathic hypersomnia (IH)
  • For narcolepsy type 1, have had at least 14 cataplexy attacks (sudden muscle weakness) in a typical two-week period
  • For IH, sleep at least 7 hours per night on average
  • Either currently taking a stable dose of an oxybate medicine for at least 2 months, or have significant daytime sleepiness (Epworth score > 11) if not on oxybate
  • Must be able to stop certain other medicines (like alerting agents or anticataplectics) during the study

View the official record on ClinicalTrials.gov

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