Actively Recruiting
A Phase 3 Study Comparing Daily Tasimelteon to Placebo for Treating Insomnia in Children Aged 2 to 17
Led by Vanda Pharmaceuticals · Updated on 2026-06-05
420
Participants Needed
35
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of tasimelteon, compared to a placebo, in children and teenagers aged 2 to 17 years who have insomnia disorder. This randomized, double-blind study aims to assess the safety and effectiveness of a daily oral dose of tasimelteon for improving sleep in this pediatric population. Participants will receive either a weight-based single daily dose of tasimelteon oral suspension or a matching placebo. The study is conducted at multiple centers and lasts for 12 weeks, during which participants will take the assigned treatment daily. Throughout the 12 weeks, participants will keep daily sleep diaries to track changes in sleep latency and other sleep parameters. Researchers will also assess daytime functioning and behavior through questionnaires. Safety will be monitored by recording any adverse events. The study includes objective sleep measurement using actigraphy to capture sleep time, ensuring thorough evaluation of treatment effects and participant well-being.
CONDITIONS
Brief Title
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Research Team
V
Vanda Pharmaceuticals, Inc.
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