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Completed Phase 2Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT02231008

Public ClinicalTrials.gov record NCT02231008. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 31, 2026, 2:30 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT02231008
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Vanda Pharmaceuticals
Industry
Enrollment
49 participants

Conditions and interventions

Eligibility (public fields only)

Age range
3 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 2015 (Actual)
Primary completion
Nov 19, 2018 (Actual)
Completion
Jan 2022 (Actual)
Last update posted
Nov 18, 2022

2015 – 2022

United States locations

U.S. sites
4
U.S. states
3
U.S. cities
4
Facility City State ZIP Site status
Not listed Santa Monica California — —
Not listed Baltimore Maryland — —
Not listed Chevy Chase Maryland — —
Not listed Houston Texas — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02231008, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 18, 2022 · Synced Oct 31, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02231008 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →