Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Insomnia Disorder

In brief

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.

Key facts

Study ID

NCT06953869

Run by

Vanda Pharmaceuticals

People needed

420

Starts

2025-04-21

Expected to finish

2028-01-01

Last updated by the study team

2026-06-05

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required).
• Confirmed clinical diagnosis of insomnia disorder
• Males and Females between 2 and 17 years, inclusive.
• The sleep disturbance must not be a result of another medication.

You may not qualify if…

• Inability to dose daily with tasimelteon or previous intolerance to tasimelteon.
• Indication of impaired liver function.
• Pregnant or lactating females.
• A positive test for drugs of abuse.

Where it is running

• Vanda Investigational Site — Sheffield, United Kingdom (enrolling)
• Vanda Investigational Site — Phoenix, Arizona, United States (enrolling)
• Vanda Investigational Site — Irvine, California, United States (enrolling)
• Vanda Investigational Site — Miami, Florida, United States (enrolling)
• Vanda Investigational Site — Miami Lakes, Florida, United States (enrolling)
• Vanda Investigational Site — Winter Park, Florida, United States (enrolling)
• Vanda Investigational Site — Snellville, Georgia, United States (enrolling)
• Vanda Investigational Site — Stockbridge, Georgia, United States (enrolling)
• Vanda Investigational Site — Naperville, Illinois, United States (enrolling)
• Vanda Investigational Site — Worcester, Massachusetts, United States (enrolling)
• Vanda Investigational Site — Great Falls, Montana, United States (enrolling)
• Vanda Investigational Site — Dothan, Alabama, United States (enrolling)
• Vanda Investigational Site — Las Vegas, Nevada, United States (enrolling)
• Vanda Investigational Site — Cleveland, Ohio, United States (enrolling)
• Vanda Investigational Site — Columbia, South Carolina, United States (enrolling)
• Vanda Investigational Site — Myrtle Beach, South Carolina, United States (enrolling)
• Vanda Investigational Site — Nashville, Tennessee, United States (enrolling)
• Vanda Investigational Site — Houston, Texas, United States (enrolling)
• Vanda Investigational Site — Plano, Texas, United States (enrolling)
• Vanda Investigational Site — San Antonio, Texas, United States (enrolling)
• Vanda Investigational Site — San Antonio, Texas, United States (enrolling)
• Vanda Investigational Site — Berlin, Germany (enrolling)
• Vanda Investigational Site — Leipzig, Germany (enrolling)
• Vanda Investigational Site — Bydgoszcz, Poland (enrolling)
• Vanda Investigational Site — Gdansk, Poland (enrolling)

Full record on ClinicalTrials.gov

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