Status:
ACTIVE_NOT_RECRUITING
Safety Study of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder in Blind Individuals With No Light Perception
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 safety of a one year open-label treatment of tasimelteon 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;
- 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
- Willing and able to comply with study requirements and restrictions including a commitment to a fixed 9-hour sleep opportunity during the study;
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;
- Smoke more than 10 cigarettes/day
- Participation in a previous tasimelteon (aka VEC-162 or BMS-214778) trial;
- Use of central nervous system prescription or OTC medications, other than melatonin, that affects the sleep-wake cycle within 3 weeks or 5 half-lives (whichever was longer) of Baseline;
- Use of melatonin or melatonin agonist;
Key Trial Info
Start Date :
October 28 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 5 2024
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01218789
Start Date
October 28 2010
End Date
December 5 2024
Last Update
April 3 2024
Active Locations (7)
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1
Garches, France
2
Lille, France
3
Lyon, France
4
Montpellier, France