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Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder

NCT01163032 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2014-10-16

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of a six month double-mask treatment of tasimelteon or placebo in male and female subjects with Non-24-Hour Sleep-Wake Disorder

Conditions

  • Non-24-Hour Sleep-Wake Disorder

Interventions

DRUG

tasimelteon

20 mg tasimelteon capsules, PO daily for 6 months

DRUG

Placebo

Placebo capsules, PO daily for 6 months

Sponsors & Collaborators

Principal Investigators

  • Vanda Pharmaceuticals · Vanda Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States
  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01163032 on ClinicalTrials.gov