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Search / Trial NCT06953869

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

Launched by VANDA PHARMACEUTICALS · Apr 23, 2025

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tasimelteon to see how well it helps children and teenagers with insomnia, which is a condition that makes it hard for them to sleep. The trial is looking for boys and girls aged between 2 and 17 years who have been diagnosed with insomnia. To participate, they need to be able to give their consent or have a legal guardian who can, and their sleep issues shouldn't be caused by other medications.

Participants in this study will take either tasimelteon or a placebo (a pill that looks the same but has no active medication) daily for a certain period. The study is designed to find out if tasimelteon is safe and effective for treating insomnia in children. It’s important to know that children who have certain health issues, like liver problems or those who are pregnant or breastfeeding, cannot join this trial. The study is currently recruiting participants, so if your child is eligible, it could be an opportunity to help improve their sleep.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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.

About Vanda Pharmaceuticals

Vanda Pharmaceuticals is a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with unmet medical needs, particularly in the fields of psychiatry and sleep disorders. With a strong focus on precision medicine, Vanda leverages cutting-edge research and clinical trial methodologies to advance novel treatments that improve patient outcomes. The company's commitment to scientific excellence and patient-centric approaches positions it as a leader in delivering transformative healthcare solutions. Through its robust pipeline and strategic partnerships, Vanda aims to enhance the quality of life for individuals affected by complex medical conditions.

Locations

Charlotte, North Carolina, United States

San Antonio, Texas, United States

Winter Park, Florida, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported