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Completed Phase 3 Interventional Results available

Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder

ClinicalTrials.gov ID: NCT01430754

Public ClinicalTrials.gov record NCT01430754. 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 19, 2026, 4:08 PM 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 Randomized Withdrawal Study to Demonstrate the Maintenance of Effect of 20 mg Tasimelteon in the Treatment of N24HSWD

Brief summary

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

The purpose of this study is to evaluate the maintenance effect and safety of 20 mg tasimelteon versus placebo in subjects suffering from Non-24-Hour Sleep-Wake Disorder.

Study identification

NCT ID
NCT01430754
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Vanda Pharmaceuticals
Industry
Enrollment
20 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Not listed
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 2011 (Type not available)
Primary completion
Dec 2012 (Actual)
Completion
Dec 2012 (Actual)
Last update posted
Oct 10, 2014

2011 – 2012

United States locations

U.S. sites
22
U.S. states
17
U.S. cities
22
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 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 —
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 —
Mercy Fitzgerald Hospital - Sleep Disorders Center (Philadelphia Metropolitan Area) Lafayette Hill Pennsylvania 19444 —
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.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01430754, 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 10, 2014 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01430754 live on ClinicalTrials.gov.

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