Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of 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 maintenance effect and safety of 20 mg tasimelteon versus placebo in subjects suffering from Non-24-Hour Sleep-Wake Disorder.

Key facts

Study ID: NCT01430754
Run by: Vanda Pharmaceuticals
People needed: 20
Starts: 2011-09-01
Expected to finish: 2012-12-01
Last updated by the study team: 2014-10-10

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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);
a. Note: A standard drink is equal to 13.7 grams (0.6 ounces) of pure alcohol or
12-ounces of beer
8-ounces of malt liquor
5-ounces of wine
1.5-ounces or a "shot" of 80-proof distilled spirits or liquor (e.g., gin, rum, vodka, or whiskey);
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);
Pregnant or lactating females;
A positive test for drugs of abuse at the screening visit; Note: A positive drug screen at Visit 1 needs to be discussed with the medical monitor and will be evaluated on a case-by-case basis.
Smoke more than 10 cigarettes/day;
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;
Unwilling or unable to follow the medication restrictions described in Section 8.2., or unwilling or unable to sufficiently wash-out from use of a restricted medication
Unable to perform calls to the study IVR system to report questionnaire results;
Any other sound medical reason as determined by the clinical investigator;
Legal incompetence or limited legal competence, detainment in an institution for official or legal reasons.

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 — 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
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
Mercy Fitzgerald Hospital - Sleep Disorders Center (Philadelphia Metropolitan Area) — Lafayette Hill, 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

Full record on ClinicalTrials.gov

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