Tasimelteon for the Treatment of Non-24-hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light Perception
An Extension Open-Label Safety Study of a 24-month 20 mg 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
1 other identifier
interventional
200
1 country
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2011
Typical duration for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2011
CompletedFirst Posted
Study publicly available on registry
September 5, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedApril 21, 2015
April 1, 2015
3.3 years
August 30, 2011
April 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with Treatment-Emergent Adverse Events (AEs)
Treatment-emergent adverse events will be summarized by presenting the number and percentage of patients having any treatment-emergent AE, having an AE in each body system, and having each individual AE.
24 months + 12 month optional extension
Secondary Outcomes (4)
Number of participants with changes in Clinical Laboratory Data
24 months + 12 month optional extension
Number of participants with newly occurring or worsening ECG abnormalities
24 months + 12 month optional extension
Number of participants with clinically notable Vital Signs and Body Measurements
24 months + 12 month optional extension
Number of participants who report a positive result for the Columbia Suicide Severity Rating Scale (C-SSRS)
24 months + 12 month optional extension
Study Arms (1)
tasimelteon
EXPERIMENTAL20 mg tasimelteon capsules, PO daily for 24 months + 12 month optional extension
Interventions
20 mg tasimelteon capsules, PO daily for 24 months + 12 month optional extension
Eligibility Criteria
You may qualify if:
- Ability and acceptance to provide informed consent;
- 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.
- 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.
- Diagnosis of N24HSWD in a previous tasimelteon study;
- Willing and able to comply with study requirements and restrictions;
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 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 (\> 40g/day);
- Patients having any current suicidal ideation of type 4 or 5 on the C-SSRS at Screening or Baseline;
- 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;
- Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;
- Clinically significant deviation from normal in vital signs measurements, or physical examination findings at screening or baseline as determined by the clinical investigator;
- Pregnant or lactating females;
- Smoke more than 10 cigarettes/day;
- Unwilling or unable to discontinue usage of medication listed in Section 8.2.1;
- Any other sound medical reason as determined by the clinical investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Pulmonary Associates, PA
Phoenix, Arizona, 85006, United States
SDS Clinical Trials Inc.
Orange, California, 92868, United States
VA Palo Alto Health Care System/PAIRE (San Fransisco Bay Area)
Palo Alto, California, 94304, United States
St. Johns Sleep Disorder Center - St. Johns Medical Plaza
Santa Monica, California, 90404, United States
Radiant Research - Denver
Denver, Colorado, 80239, United States
PAB Clinical Research Inc.
Brandon, Florida, 33511, United States
Kendall South Medical Center, Inc.
Miami, Florida, 33185, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174, United States
Sleep Disorders Center Of Georgia
Atlanta, Georgia, 30342, United States
Suburban Lung Associates SC (Chicago Metropolitan Area)
Elk Grove Village, Illinois, 60007, United States
The Center for Sleep and Wake Disorders (Washington, D.C. Metropolitan Area)
Chevy Chase, Maryland, 20815, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Michigan Head-Pain Neurological Institute
Ann Arbor, Michigan, 48104, United States
St. Luke's Sleep Medicine and Research Center (St. Louis Metropolitan Area)
Chesterfield, Missouri, 63017, United States
New York Eye and Ear Infirmary
New York, New York, 10003, United States
Ohio Sleep Medicine Institute (Columbus Metropolitan Area)
Dublin, Ohio, 43017, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Columbia Research Group Inc.
Portland, Oregon, 97239, United States
Center for Sleep Medicine at Chestnut Hill Hospital
Philadelphia, Pennsylvania, 19118, United States
Consolidated Clinical trials
Pittsburgh, Pennsylvania, 15221, United States
SleepMed, Inc. - Columbia
Columbia, South Carolina, 29201, United States
Todd J. Swick, M.D., P.A.
Houston, Texas, 77063, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Vanda Pharmaceuticals
Vanda Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2011
First Posted
September 5, 2011
Study Start
October 1, 2011
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
April 21, 2015
Record last verified: 2015-04