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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2022-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Smith-Magenis Syndrome Circadian

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Tasimelteon

Single dose oral capsule or equivalent age-appropriate oral formulation, daily dosage

Group Type EXPERIMENTAL

tasimelteon

Intervention Type DRUG

Placebo

Placebo comparator

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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tasimelteon

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No