Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia (NCT06953869)
A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
🩺 Plain-English Summary (8th-Grade Level)
This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.
Who can join: Review the eligibility criteria below.
Location: Vanda Investigational Site — Dothan, Alabama
Age range: 2 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (35 Sites)
Showing the first 25 of 35 sites.
- Vanda Investigational Site — Dothan, Alabama
- Vanda Investigational Site — Phoenix, Arizona
- Vanda Investigational Site — Irvine, California
- Vanda Investigational Site — Miami, Florida
- Vanda Investigational Site — Miami Lakes, Florida
- Vanda Investigational Site — Winter Park, Florida
- Vanda Investigational Site — Snellville, Georgia
- Vanda Investigational Site — Stockbridge, Georgia
- Vanda Investigational Site — Naperville, Illinois
- Vanda Investigational Site — Worcester, Massachusetts
- Vanda Investigational Site — Great Falls, Montana
- Vanda Investigational Site — Lincoln, Nebraska
- Vanda Investigational Site — Las Vegas, Nevada
- Vanda Investigational Site — Cleveland, Ohio
- Vanda Investigational Site — Columbia, South Carolina
- Vanda Investigational Site — Myrtle Beach, South Carolina
- Vanda Investigational Site — Nashville, Tennessee
- Vanda Investigational Site — Houston, Texas
- Vanda Investigational Site — Plano, Texas
- Vanda Investigational Site — San Antonio, Texas
- Vanda Investigational Site — San Antonio, Texas
- Vanda Investigational Site — Berlin,
- Vanda Investigational Site — Leipzig,
- Vanda Investigational Site — Bydgoszcz,
- Vanda Investigational Site — Gdansk,
📞 Contact the Study Coordinator
Phone: (202) 734-3400
Email: VEC162@vandapharma.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Insomnia Disorder
- Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant) — Wilmington, Delaware
- Assessing Modified CBTi in Adults With Insomnia Disorder — Pocatello, Idaho
- Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study 2 — San Francisco, California
- Virtual Reality Relaxation for Insomnia — Québec, Quebec
- Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia — Québec, Quebec
Explore by condition: All Insomnia Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.