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OpenTrials
Completed

NCT Number: NCT02231008

Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS

The aim of this study is to investigate tasimelteon vs. placebo on sleep disturbances of individuals with Smith-Magenis Syndrome.

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Key information

Conditions

Smith-Magenis Syndrome Abnormalities, Multiple Chromosome Disorders Chronobiology Disorders Circadian Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Nervous System Diseases

Age range

3 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Santa Monica, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A confirmed clinical diagnosis of SMS
  • Informed consent from the patient or the legal guardian
  • Male or female between the ages of 3- 65 years of age
  • Recent history of sleep disturbances
  • Have an appointed care-giver complete the required outpatient assessments
  • Willing and able to comply with study requirements and restrictions

Exclusion criteria

  • Unable to dose daily with medication
  • Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever was longer) of screening
  • Any other sound medical reason as determined by the clinical investigator

Treatment and study plan

tasimelteon

Drug

Placebo

Drug

Primary outcomes

  1. To determine the efficacy of tasimelteon administered daily compared to placebo, as measured by improvement in sleep parameters

    Time frame: 9 Weeks

Secondary outcomes

  1. Safety and tolerability as measured by spontaneous reporting of adverse events (AEs).

    Time frame: up to 137 weeks

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

A Double-blind, Randomized, Two-period Crossover Study Evaluating the Effects of Tasimelteon vs. Placebo on Sleep Disturbances of Individuals With Smith-Magenis Syndrome (SMS)

Important dates

Study start
2015
Primary completion
2018
Study completion
2022
First posted
Sep 3, 2014
Registry last updated
Nov 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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