Tasimelteon for the Treatment of Non-24-hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light Perception

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety of tasimelteon in male and female patients who suffer from Non-24-Hour Sleep-Wake Disorder.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanda Pharmaceuticals

Criteria

Inclusion Criteria:

1. Ability and acceptance to provide informed consent;

2. Men or women at least 18 years of age or older who meet one of the following:

• Has enrolled in VP-VEC-162-3201 (with sponsor approval)

• Has completed VP-VEC-162-3203

• Was deemed a non-responder in VP-VEC-162-3203

• Has enrolled in VP-VEC-162-3203 (with sponsor approval)

• Has a previous diagnosis of N24HSWD

• The subject is totally blind and meets the following Diagnostic and Statistical Manual of Mental Disorders 5 diagnostic criteria

• A persistent or recurrent pattern of sleep disruption that is primarily due to an alteration of the circadian system or to a misalignment between the endogenous circadian rhythm and the sleep-wake schedule required by an individual's physical environment or social or professional schedule.

• The sleep disruption leads to excessive sleepiness or insomnia, or both.

• The sleep disturbance causes clinically significant distress or impairment in social, occupational, and other important areas of functioning.

Specifically: A pattern of sleep-wake cycles that is not synchronized to the 24-hour environment, with a consistent daily drift (usually to later and later times) of sleep onset and wake times.

3. For US participants only: 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 during the study and for one month following the last dose 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.

4. Diagnosis of N24HSWD in a previous tasimelteon study;

5. Willing and able to comply with study requirements and restrictions;

Exclusion Criteria:

1. 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;

2. History of intolerance and/or hypersensitivity to melatonin or melatonin agonists;

3. 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 (> 40g/day);

4. Patients having any current suicidal ideation of type 4 or 5 on the C-SSRS at Screening or Baseline;

5. Patient 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;

6. Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;

7. Clinically significant deviation from normal in vital signs measurements, or physical examination findings at screening or baseline as determined by the clinical investigator;

8. Pregnant or lactating females;

9. Smoke more than 10 cigarettes/day;

10. Exposure to any investigational drug other than tasimelteon, including placebo, within 30 days, 5 half-lives, or the exclusion period given by a previous study in which the patient has participated in, whichever of the three scenarios is longer.

11. Unwilling or unable to discontinue usage of medication listed in Section 8.2.1;

12. Any other sound medical reason as determined by the clinical investigator.