Evaluating Tasimelteon for Pediatric Insomnia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, double-blind, randomized study aims to assess the efficacy and safety of a daily oral dose of tasimelteon compared to a placebo in treating insomnia disorder in pediatric patients. Participants aged 2 to 17 years will be enrolled, and the study will monitor their response to the treatment over a specified period. The study is designed to ensure that the sleep disturbances are not caused by other medications, focusing solely on the effects of tasimelteon.

Why it matters

Who can join: the full rules

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.

Where it's running

• Vanda Investigational Site
  Dothan, Alabama, United States Recruiting
• Vanda Investigational Site
  Phoenix, Arizona, United States Recruiting
• Vanda Investigational Site
  Irvine, California, United States Recruiting
• Vanda Investigational Site
  Miami, Florida, United States Recruiting
• Vanda Investigational Site
  Miami Lakes, Florida, United States Recruiting
• Vanda Investigational Site
  Winter Park, Florida, United States Recruiting

Study contacts

• Study coordinator: Vanda Pharmaceuticals, Inc.
• Email: VEC162@vandapharma.com
• Phone: 202-734-3400

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Does Yoga Style Affect Sleep and Heart Health in Adults with and without Insomnia

  This study tests whether two styles of yoga (vinyasa and gentle yoga) done in the evening can improve sleep and heart health in adults, including those with insomnia.

  Recruiting University of Central Florida · Orlando, Florida · NCT07638267

• Virtual reality relaxation for insomnia

  Researchers are testing a VR relaxation program to see if it helps adults with insomnia sleep better and feel less tense before bed.

  Recruiting Laval University · Québec, Quebec · NCT07630532

• Auricular acupuncture given by village doctors to help sleep in elderly with diabetes and high blood pressure

  This study tests whether village doctors can help elderly people with diabetes and hypertension sleep better using ear needle therapy, compared with a sham treatment.

  Recruiting Jiangsu Taizhou People's Hospital · Taizhou, Jiangsu · NCT07554235

• A smart look at common sleep meds for insomnia

  This trial tests how well and how safely widely used sleep medicines and OTCs work for adults with insomnia and which might be best overall.

  Recruiting Phase 4 University of Pennsylvania · Philadelphia, Pennsylvania · NCT07542756

• Combining online CBT-I with passive body heating using a sauna blanket for insomnia

  This study will see if adding passive body heating with a sauna blanket to digital CBT-I helps adults with insomnia fall asleep faster and sleep better over nine weeks.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07036705

• Comparing CBT-I and Lemborexant for Chronic Insomnia

  This study is testing whether Cognitive Behavioral Therapy for Insomnia or the medication lemborexant can help people with insomnia, especially those dealing with anxiety and depression, feel better compared to a placebo.

  Recruiting Laval University · Québec, Quebec · NCT06779149

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.