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

Completed · Phase 3 · Has a placebo group

Conditions studied: Non-24-Hour Sleep-Wake Disorder

In brief

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

Key facts

Study ID

NCT01163032

Run by

Vanda Pharmaceuticals

People needed

136

Starts

2010-08-01

Expected to finish

2012-11-01

Last updated by the study team

2014-10-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability and acceptance to provide informed consent;
• No perception of light by the subject's own report;
• Diagnosis of N24HSWD as determined by:
• History (within the last 3 months) of trouble sleeping at night difficulty initiating sleep or staying asleep), difficulty awakening in the morning, or daytime sleepiness as determined by answering yes to at least one question in the Sleep Complaint Questionnaire and
• Urinary aMT6s demonstrates a progressive delay of the aMT6 acrophase time.
• Willing and able to comply with study requirements and restrictions including a commitment to a fixed 9-hour sleep opportunity during the study;
• Fluent in English;

You may not qualify if…

• Have a probable diagnosis of a current sleep disorder other than N24HSWD that is the primary cause of the sleep disturbance based on clinical investigator medical judgment;
• Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;
• History (within the 12 months prior to screening) of psychiatric disorders including Major Depressive Disorder, Generalized Anxiety Disorder, Axis II Disorders, delirium or any other psychiatric disorder that in the opinion of the clinical investigator would affect participation in the study or full compliance with study procedures;
• History of intolerance and/or hypersensitivity to melatonin or melatonin agonists;
• Worked night, rotating, or split (period of work, followed by break, and then return to work) shift work within 1 month of the screening visit or plan to work these shifts during the study;
• Unable to perform calls to the study IVR system to report questionnaire results;
• Exposure to any investigational drug, including placebo, within 30 days or 5 half lives (whichever was longer) of screening;
• Use of central nervous system prescription or OTC medications, other than melatonin, that affects the sleep-wake cycle
• Use of melatonin or melatonin agonist

Where it is running

• Pulmonary Associates, PA — Phoenix, Arizona, United States
• SDS Clinical Trials Inc. — Orange, California, United States
• VA Palo Alto Health Care System/PAIRE (San Fransisco Bay Area) — Palo Alto, California, United States
• St. Johns Sleep Disorder Center - St. Johns Medical Plaza — Santa Monica, California, United States
• Radiant Research - Denver — Denver, Colorado, United States
• PAB Clinical Research Inc. — Brandon, Florida, United States
• Kendall South Medical Center, Inc. — Miami, Florida, United States
• Ocean Sleep Disorders Center - Ormond Beach — Ormond Beach, Florida, United States
• Sleep Disorders Center Of Georgia — Atlanta, Georgia, United States
• Suburban Lung Associates SC (Chicago Metropolitan Area) — Elk Grove Village, Illinois, United States
• The Center for Sleep and Wake Disorders (Washington, D.C. Metropolitan Area) — Chevy Chase, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Michigan Head-Pain Neurological Institute — Ann Arbor, Michigan, United States
• St. Luke's Sleep Medicine and Research Center (St. Louis Metropolitan Area) — Chesterfield, Missouri, United States
• New York Eye and Ear Infirmary — New York, New York, United States
• Tri-State Sleep Disorders Center — Cincinnati, Ohio, United States
• Ohio Sleep Medicine Institute (Columbus Metropolitan Area) — Dublin, Ohio, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
• Columbia Research Group Inc. — Portland, Oregon, United States
• Center For Sleep Medicine at Chestnut Hill Hospital — Philadelphia, Pennsylvania, United States
• Consolidated Clinical trials — Pittsburgh, Pennsylvania, United States
• SleepMed, Inc. - Columbia — Columbia, South Carolina, United States
• Todd J. Swick, M.D., P.A. — Houston, Texas, United States
• Advanced Sleep Research GmbH — Berlin, Germany
• Bergmannsheil University Hospital - Medical Clinic III — Bochum, Germany

Full record on ClinicalTrials.gov

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