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

Smith-Magenis Syndrome Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02231008
• Other study ID #: VP-VEC-162-2401
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2015
• Est. completion date: January 2022

Study information

• Verified date: November 2022
• Source: Vanda Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 2022
• Est. primary completion date: November 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Circadian
• Dyssomnias
• Parasomnias
• Smith-Magenis Syndrome
• Syndrome

Intervention

Drug:
• tasimelteon

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the efficacy of tasimelteon administered daily compared to placebo, as measured by improvement in sleep parameters		9 Weeks
Secondary	Safety and tolerability as measured by spontaneous reporting of adverse events (AEs).		up to 137 weeks