Trial record 18 of 40 for:    "Sleep Disorders, Circadian Rhythm"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Vanda Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01218789
First received: September 28, 2010
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Non 24 Hour Sleep Wake Disorder
Drug: tasimelteon
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Vanda Pharmaceuticals:

Primary Outcome Measures:
  • Safety Evaluations [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Week 16 ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Week 26 ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Week 34 ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Week 42 ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]

    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) [ Time Frame: Weeks 8, 16, 26, 34, 42, 52 ] [ Designated as safety issue: No ]
    A patient rated assessment of reported nighttime sleep

  • Clinical Global Impression of Change (CGI-C) [ Time Frame: Weeks 8, 16, 26, 34, 42, 52 ] [ Designated as safety issue: No ]
    rate of total improvement due to drug as viewed by the clinician

  • Patient Global Impression of Change (PGI-C) [ Time Frame: Weeks 8, 16, 26, 34, 42, 52 ] [ Designated as safety issue: No ]
    A patient rated assessment on daytime naps


Estimated Enrollment: 140
Study Start Date: September 2010
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tasimelteon
20 mg tasimelteon capsules, PO daily for 1 year
Drug: tasimelteon
20 mg tasimelteon capsules, PO daily for 1 year
Other Name: VEC-162

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218789

Contacts
Contact: Vanda Pharmaceuticals 1-877-486-4817

Locations
France
Recruiting
Garches, France
Recruiting
Lille, France
Recruiting
Lyon, France
Recruiting
Montpellier, France
Recruiting
Paris, France
Recruiting
Rennes, France
Recruiting
Toulouse, France
Sponsors and Collaborators
Vanda Pharmaceuticals
  More Information

No publications provided

Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01218789     History of Changes
Other Study ID Numbers: VP-VEC-162-3202
Study First Received: September 28, 2010
Last Updated: June 5, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United States: Food and Drug Administration

Keywords provided by Vanda Pharmaceuticals:
Blindness
Eye Diseases
Nap Disorders
Circadian Rhythm Disorders
Sleep disorders
Circadian Rhythm Sleep Disorders
Dyssomnias
Nervous System Diseases

Additional relevant MeSH terms:
Disease
Sleep Disorders, Circadian Rhythm
Chronobiology Disorders
Dyssomnias
Mental Disorders
Nervous System Diseases
Occupational Diseases
Pathologic Processes
Sleep Disorders

ClinicalTrials.gov processed this record on October 29, 2014