AN EXTENSION OPEN-LABEL SAFETY STUDY OF A 24-MONTH 20MG DOSE REGIMEN OF TASIMELTEON FOR THE TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER (N24HSWD) IN BLIND INDIVIDUALS WITH NO LIGHT PERCEPTION WHO HAVE ENROLLED IN OTHER TASIMELTEON CLINICAL TRIALS
- Conditions
- Blind males or females with no conscious light perception and thecomplaint of a sleep-wake disorder associated with Non-24 Hour Sleep-Wake DisorderMedDRA version: 16.1Level: PTClassification code 10009191Term: Circadian rhythm sleep disorderSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Body processes [G] - Biological Phenomena [G16]
- Registration Number
- EUCTR2011-004520-35-DE
- Lead Sponsor
- Vanda Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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:
a. Has enrolled in VP-VEC-162-3201 (with sponsor approval)
b. Has completed VP-VEC-162-3203 (for US participants only)
c. Did not have a qualifying tau for randomization in VP-VEC-162-3203 (for US participants only)
d. Has enrolled in VP-VEC-162-3203 (with sponsor approval - for US participants only)
3. Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or subject is postmenopausal, without menses for 1 year before screening), or females of child-bearing potential using 2 independent barrier methods of birth control (i.e., condoms, diaphragm, spermicidal agents, cervical cap) for a period of 35 days before the first dosing, during the study and for one month after the last dose and must have a negative pregnancy test at the screening and baseline visits; Note: Hormonal contraception is not considered a reliable method of birth control in this study.
Note: For patients over 55 years of age at the screening visit absence of menses for 1 year before screening is sufficient to establish the postmenopausal status. The postmenopausal status of a patient under 55 years of age at the screening visit will be confirmed by measuring the following hormones:
• Follicle-stimulating hormone (FSH) =40 mIU/mL
• Estradiol = 30 pg/mL (110.1 pmol/L)
4. Diagnosis of N24HSWD in a previous tasimelteon study;
5. Willing and able to comply with study requirements and restrictions
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 133
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 67
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method