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Safety Study of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder in Blind Individuals With No Light Perception

Primary Purpose

Non 24 Hour Sleep Wake Disorder

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
tasimelteon
Sponsored by
Vanda Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non 24 Hour Sleep Wake Disorder focused on measuring Blindness, Eye Diseases, Nap Disorders, Circadian Rhythm Disorders, Sleep disorders, Circadian Rhythm Sleep Disorders, Dyssomnias, Nervous System Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability and acceptance to provide informed consent;
  • No perception of light;
  • History (within the last 3 months) of trouble sleeping at night difficulty initiating sleep or staying asleep), difficulty awakening in the morning, or daytime sleepiness as determined by answering yes to at least one question in the Sleep Complaint Questionnaire
  • Willing and able to comply with study requirements and restrictions including a commitment to a fixed 9-hour sleep opportunity during the study;

Exclusion Criteria:

  • Have a probable diagnosis of a current sleep disorder other than N24HSWD that is the primary cause of the sleep disturbance based on clinical investigator medical judgment;
  • Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable;
  • 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;
  • Smoke more than 10 cigarettes/day
  • Participation in a previous tasimelteon (aka VEC-162 or BMS-214778) trial;
  • Use of central nervous system prescription or OTC medications, other than melatonin, that affects the sleep-wake cycle within 3 weeks or 5 half-lives (whichever was longer) of Baseline;
  • Use of melatonin or melatonin agonist;

Sites / Locations

  • Recruiting
  • Recruiting
  • Recruiting
  • Recruiting
  • Recruiting
  • Recruiting
  • Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tasimelteon

Arm Description

20 mg tasimelteon capsules, PO daily for 1 year

Outcomes

Primary Outcome Measures

Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.

Secondary Outcome Measures

Patient Global Impression of Change (PGI-C)
A patient rated assessment of reported nighttime sleep
Clinical Global Impression of Change (CGI-C)
rate of total improvement due to drug as viewed by the clinician
Patient Global Impression of Change (PGI-C)
A patient rated assessment on daytime naps

Full Information

First Posted
September 28, 2010
Last Updated
November 14, 2017
Sponsor
Vanda Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01218789
Brief Title
Safety Study of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder in Blind Individuals With No Light Perception
Official Title
Open-Label Safety Study of a 1-Year 20 mg Dose Regimen of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder (N24HSWD) in Blind Individuals With No Light Perception
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety of a one year open-label treatment of tasimelteon in male and female subjects with Non-24-Hour Sleep-Wake Disorder.
Detailed Description
Non-24-Hour Sleep-Wake Disorder (N24HSWD) occurs when individuals, primarily those without light perception, are unable to synchronize their endogenous circadian pacemaker to the 24-hour light-dark cycle, and the timing of their circadian rhythm instead reflects the intrinsic period of their endogenous circadian pacemaker. As a result, the circadian rhythm of sleep-wake propensity in these individuals moves gradually later and later each day if there circadian period is > 24 hours and earlier and earlier if < 24 hours. These individuals will be able to sleep well at night when their sleep-wake propensity rhythm is approximately aligned with the 24-hour light-dark and social cycle. However, after a short time, the endogenous sleep-wake propensity rhythm and the 24-hour light-dark cycle will move out of synchrony with each other, and they may have difficulty falling asleep until well into the night. In addition to problems sleeping at the desired time, the subjects experience daytime sleepiness and daytime napping. This will be a multicenter, open-label study. The study has two phases: the screening phase and the evaluation phase. The screening phase is comprised of a screening visit where a patient's general health and initial eligibility will be evaluated. The evaluation phase is comprised of a baseline visit and a 52 week segment. Patients that meet all entry criteria for the study at baseline visit will enter the treatment segment where patients will be asked to take 20 mg tasimelteon daily approximately 60 minutes prior to their target bedtime for 52 weeks in an open-label fashion. An optional sub-study extension phase is available to subjects who complete the first year of treatment and consists of continued open-label treatment for up to 3 years additional.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non 24 Hour Sleep Wake Disorder
Keywords
Blindness, Eye Diseases, Nap Disorders, Circadian Rhythm Disorders, Sleep disorders, Circadian Rhythm Sleep Disorders, Dyssomnias, Nervous System Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tasimelteon
Arm Type
Experimental
Arm Description
20 mg tasimelteon capsules, PO daily for 1 year
Intervention Type
Drug
Intervention Name(s)
tasimelteon
Other Intervention Name(s)
VEC-162
Intervention Description
20 mg tasimelteon capsules, PO daily for 1 year
Primary Outcome Measure Information:
Title
Safety Evaluations
Description
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Time Frame
Week 4
Title
Safety Evaluations
Description
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Time Frame
Week 8
Title
Safety Evaluations
Description
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Time Frame
Week 12
Title
Safety Evaluations
Description
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Time Frame
Week 16
Title
Safety Evaluations
Description
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Time Frame
Week 26
Title
Safety Evaluations
Description
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Time Frame
Week 34
Title
Safety Evaluations
Description
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Time Frame
Week 42
Title
Safety Evaluations
Description
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Patient Global Impression of Change (PGI-C)
Description
A patient rated assessment of reported nighttime sleep
Time Frame
Weeks 8, 16, 26, 34, 42, 52
Title
Clinical Global Impression of Change (CGI-C)
Description
rate of total improvement due to drug as viewed by the clinician
Time Frame
Weeks 8, 16, 26, 34, 42, 52
Title
Patient Global Impression of Change (PGI-C)
Description
A patient rated assessment on daytime naps
Time Frame
Weeks 8, 16, 26, 34, 42, 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability and acceptance to provide informed consent; No perception of light; History (within the last 3 months) of trouble sleeping at night difficulty initiating sleep or staying asleep), difficulty awakening in the morning, or daytime sleepiness as determined by answering yes to at least one question in the Sleep Complaint Questionnaire Willing and able to comply with study requirements and restrictions including a commitment to a fixed 9-hour sleep opportunity during the study; Exclusion Criteria: Have a probable diagnosis of a current sleep disorder other than N24HSWD that is the primary cause of the sleep disturbance based on clinical investigator medical judgment; Current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable; 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; Smoke more than 10 cigarettes/day Participation in a previous tasimelteon (aka VEC-162 or BMS-214778) trial; Use of central nervous system prescription or OTC medications, other than melatonin, that affects the sleep-wake cycle within 3 weeks or 5 half-lives (whichever was longer) of Baseline; Use of melatonin or melatonin agonist;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanda Pharmaceuticals
Phone
1-877-486-4817
Facility Information:
City
Garches
Country
France
Individual Site Status
Recruiting
City
Lille
Country
France
Individual Site Status
Recruiting
City
Lyon
Country
France
Individual Site Status
Recruiting
City
Montpellier
Country
France
Individual Site Status
Recruiting
City
Paris
Country
France
Individual Site Status
Recruiting
City
Rennes
Country
France
Individual Site Status
Recruiting
City
Toulouse
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Safety Study of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder in Blind Individuals With No Light Perception

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