Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder
Public ClinicalTrials.gov record NCT01163032. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Mask, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of 20 mg Tasimelteon Versus Placebo in Totally Blind Subjects With N24HSWD Followed by an OLE Phase
Study identification
- NCT ID
- NCT01163032
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Vanda Pharmaceuticals
- Industry
- Enrollment
- 136 participants
Conditions and interventions
Conditions
Interventions
- tasimelteon Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 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
- Jul 31, 2010
- Primary completion
- Oct 31, 2012
- Completion
- Oct 31, 2012
- Last update posted
- Oct 15, 2014
2010 – 2012
United States locations
- U.S. sites
- 23
- U.S. states
- 17
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pulmonary Associates, PA | Phoenix | Arizona | 85006 | — |
| SDS Clinical Trials Inc. | Orange | California | 92868 | — |
| VA Palo Alto Health Care System/PAIRE (San Fransisco Bay Area) | Palo Alto | California | 94304 | — |
| St. Johns Sleep Disorder Center - St. Johns Medical Plaza | Santa Monica | California | 90404 | — |
| Radiant Research - Denver | Denver | Colorado | 80239 | — |
| PAB Clinical Research Inc. | Brandon | Florida | 33511 | — |
| Kendall South Medical Center, Inc. | Miami | Florida | 33175 | — |
| Ocean Sleep Disorders Center - Ormond Beach | Ormond Beach | Florida | 32174 | — |
| Sleep Disorders Center Of Georgia | Atlanta | Georgia | 30342 | — |
| Suburban Lung Associates SC (Chicago Metropolitan Area) | Elk Grove Village | Illinois | 60007 | — |
| The Center for Sleep and Wake Disorders (Washington, D.C. Metropolitan Area) | Chevy Chase | Maryland | 20815 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Michigan Head-Pain Neurological Institute | Ann Arbor | Michigan | 48104 | — |
| St. Luke's Sleep Medicine and Research Center (St. Louis Metropolitan Area) | Chesterfield | Missouri | 63017 | — |
| New York Eye and Ear Infirmary | New York | New York | 10003 | — |
| Tri-State Sleep Disorders Center | Cincinnati | Ohio | 45246 | — |
| Ohio Sleep Medicine Institute (Columbus Metropolitan Area) | Dublin | Ohio | 43017 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Columbia Research Group Inc. | Portland | Oregon | 97239 | — |
| Center For Sleep Medicine at Chestnut Hill Hospital | Philadelphia | Pennsylvania | 19118 | — |
| Consolidated Clinical trials | Pittsburgh | Pennsylvania | 15221 | — |
| SleepMed, Inc. - Columbia | Columbia | South Carolina | 29201 | — |
| Todd J. Swick, M.D., P.A. | Houston | Texas | 77063 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01163032, 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 Oct 15, 2014 · Synced Jul 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01163032 live on ClinicalTrials.gov.