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

NCT01218789 | Active Not Recruiting Phase 3

• 1 other identifier: VP-VEC-162-3202
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

• 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.

  Week 4

• 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.

  Week 8

• 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.

  Week 12

• 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.

  Week 16

• 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.

  Week 26

• 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.

  Week 34

• 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.

  Week 42

• 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.

  Week 52

Secondary Outcomes (3)

• Patient Global Impression of Change (PGI-C)

  Weeks 8, 16, 26, 34, 42, 52

• Clinical Global Impression of Change (CGI-C)

  Weeks 8, 16, 26, 34, 42, 52

• Patient Global Impression of Change (PGI-C)

  Weeks 8, 16, 26, 34, 42, 52

Study Arms (1)

tasimelteon

EXPERIMENTAL

20 mg tasimelteon capsules, PO daily for 1 year

Drug: tasimelteon

Interventions

tasimelteon DRUG

20 mg tasimelteon capsules, PO daily for 1 year

Also known as: VEC-162

tasimelteon

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Vanda Pharmaceuticals: lead

Study Sites (7)

Unknown Facility

Garches, France

Location

Unknown Facility

Lille, France

Location

Unknown Facility

Lyon, France

Location

Unknown Facility

Montpellier, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Rennes, France

Location

Unknown Facility

Toulouse, France

Location

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm; Blindness; Eye Diseases; Chronobiology Disorders; Sleep Wake Disorders; Dyssomnias; Nervous System Diseases

Interventions

tasimelteon

Condition Hierarchy (Ancestors)

Occupational Diseases; Mental Disorders; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: September 28, 2010
• First Posted: October 11, 2010
• Study Start: October 28, 2010
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

FR (7)