Status:
COMPLETED
Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Non-24-Hour Sleep-Wake Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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
Detailed Description
Non-24-Hour Sleep-Wake Disorder (N24HSWD) occurs when individuals, primarily those without light perception, are unable to synchronize their endogenous circadian pacemaker to the 24-hour light-dark cy...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT01163032
Start Date
August 1 2010
End Date
November 1 2012
Last Update
October 16 2014
Active Locations (28)
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1
Pulmonary Associates, PA
Phoenix, Arizona, United States, 85006
2
SDS Clinical Trials Inc.
Orange, California, United States, 92868
3
VA Palo Alto Health Care System/PAIRE (San Fransisco Bay Area)
Palo Alto, California, United States, 94304
4
St. Johns Sleep Disorder Center - St. Johns Medical Plaza
Santa Monica, California, United States, 90404