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

Vanda Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Circadian; Smith-Magenis Syndrome

Treatments: Drug: tasimelteon; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02231008

VP-VEC-162-2401

Details and patient eligibility

About

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

Enrollment: 49 patients

Sex: All

Ages: 3 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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49 participants in 2 patient groups, including a placebo group

Tasimelteon

Experimental group

Description:

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

Treatment:

Drug: tasimelteon

Placebo

Placebo Comparator group

Description:

Placebo comparator

Treatment:

Drug: placebo