Safety Study of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder in Blind Individuals With No Light Perception
NCT01218789 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2024-04-03
Summary
The purpose of this study is to evaluate the safety of a one year open-label treatment of tasimelteon 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 1 year
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-10-28
- Primary Completion
- 2024-12-05
- Completion
- 2024-12-05
Countries
- France
Study Locations
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