CompletedPhase 3

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

United States20 participantsStarted 2011-09

Plain-language summary

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.

Who can participate

SexALL

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Inclusion criteria

✓. Ability and acceptance to provide informed consent;
✓. Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or subject is postmenopausal, without menses for 6 months before screening), or females of child-bearing potential using an acceptable method of birth control for a period of 35 days before the first dosing and must have a negative pregnancy test at the screening and baseline visits; Note: Women using hormonal methods of birth control must use an additional method of birth control during the study and for one month after the last dose.
✓. Willing and able to comply with study requirements and restrictions including a commitment to a fixed 9-hour sleep opportunity during the study;
✓. Diagnosis of N24HSWD in a previous clinical trial as measured by a tau value of \> 24.1 and the lower bound of the 95% CI is \> 24.

Exclusion criteria

✕. 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 is not being successfully treated or has not been resolved and 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;
✕. History of drug or alcohol abuse as defined in DSM-IV, Diagnostic Criteria for Drug and Alcohol Abuse, within the 12 months prior to screening and/or regular consumption of alcoholic drinks (\> 2 drinks/day or \> 14 drinks/week);
✕. Subject is at risk of suicide, in the opinion of the Investigator. Evidence of suicide risk could include any suicide attempt within the past year or any other suicidal behavior within the past year;
✕. Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;
✕. Subjects who have estimated creatinine clearance (CLcr; based on the Cockcroft-Gault equation) ≤ to 55 mL/min;
✕. Clinically significant deviation from normal in clinical laboratory results, vital signs measurements, or physical examination findings at screening as determined by the clinical investigator;
✕. Indication of impaired liver function (values for AST, ALT or bilirubin \> 2 times Upper Limit of Normal);

What they're measuring

Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD.

Timeframe: Approximately 12 weeks

Trial details

NCT IDNCT01430754

SponsorVanda Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-12

Results submitted2014-08-08

View on ClinicalTrials.gov More Non-24-Hour Sleep-Wake Disorder trials