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

November 15, 2022 updated by: Vanda Pharmaceuticals

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Chevy Chase, Maryland, United States
    • Texas
      • Houston, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo comparator
Drug: placebo
Experimental: Tasimelteon
Single dose oral capsule or equivalent age-appropriate oral formulation, daily dosage
Drug: tasimelteon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the efficacy of tasimelteon administered daily compared to placebo, as measured by improvement in sleep parameters
Time Frame: 9 Weeks
9 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability as measured by spontaneous reporting of adverse events (AEs).
Time Frame: up to 137 weeks
up to 137 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

November 19, 2018

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

August 29, 2014

First Submitted That Met QC Criteria

September 2, 2014

First Posted (Estimate)

September 3, 2014

Study Record Updates

Last Update Posted (Actual)

November 18, 2022

Last Update Submitted That Met QC Criteria

November 15, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VEC-162-2401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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