Efficacy and Safety of Circadin for Non-24 Hour Sleep-Wake Disorder in Totally Blind Subjects

This study has been completed.
Sponsor:
Information provided by:
Neurim Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT00972075
First received: September 3, 2009
Last updated: September 6, 2009
Last verified: September 2009
  Purpose

The aim of this placebo-controlled randomized study was to evaluate the efficacy of Circadin™ 2 mg in improving total night sleep duration and stabilizing the circadian clock phase in totally blind subjects with non-24 hour sleep-wake disorder.


Condition Intervention Phase
Non-24 Hour Sleep-Wake Disorder
Blindness
Drug: melatonin (Circadin)
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of Circadin™ for Non-24 Hour Sleep-Wake Disorder in Totally Blind Subjects

Resource links provided by NLM:


Further study details as provided by Neurim Pharmaceuticals Ltd.:

Primary Outcome Measures:
  • Total sleep time [ Time Frame: six weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Daily diary records of sleep latency, sleep maintenance , total duration of naps; [ Time Frame: six weeks ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: February 2006
Study Completion Date: October 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Circadin
Circadin is 2 mg of prolonged release melatonin
Drug: melatonin (Circadin)
2 mg prolonged release melatonin tablets once daily 2 hours before going to bed
Other Names:
  • Circadin
  • ATC code N05CH01
Placebo Comparator: Placebo Drug: placebo
one tablet per day 2 hours before going to bed

Detailed Description:

This was a multi-center, double-blind, placebo-controlled study of a once-daily (QD) dose of Circadin™ 2 mg in subjects with non-24 hour sleep-wake disorder. Subjects were initially treated with placebo for 2 weeks and then were randomly assigned in a 1:1 ratio to receive Circadin™ 2 mg or placebo for 6 weeks, followed by a 2-week washout period. The primary objective was to assess the effect of Circadin 2 mg given once daily for 6 weeks on total night sleep duration. Secondary objectives were other sleep variables recorded by the diary like sleep latency, daytime naps and sleep offset time. Other endpoints were CGIC score for Severity of Illness and Global Improvement and WHO (Five) Well-Being Index score.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects aged 20-80, having no conscious perception of light.
  • Meeting the criteria for diagnosing Non-24h cycle in the clinical setting: 1) difficulty initiating sleep or difficulty in awakening, 2) progressive delay of sleep phase with inability to maintain entrainment to 24-hour-day, and 3) presence of the sleep pattern for at least six weeks.
  • Average total night sleep duration of less than 6 hours per night for at least six weeks.
  • Ability to ingest oral medication and participate in all scheduled evaluations.
  • Signing of the Informed Consent approved by the Ethics Committee. The Informed Consent will be written in both Braille and black-and-white forms for blind subject and sighted witness.
  • Education or a work history sufficient to exclude mental retardation.
  • Stable medications for non-excluded concurrent medical conditions for four weeks prior to the screening visit.

Exclusion Criteria:

  • Presence of medical disorders other than those related to blindness and medical treatment that may influence melatonin production, sleep or alertness. To be ascertained by medical history, complete physical examination including ECG and general biochemical work-up including complete blood count, serum chemistries, and urine analysis.
  • Presence of a psychiatric or mental disorder to be assessed by a structured psychiatric interview performed by a trained individual.
  • History of seizure disorders.
  • Irregular lifestyle or life pattern (e.g. shift workers and patients unable to keep the study routine).
  • Presence of a sleep problem revealed that may explain the subjects' complaints, such as sleep disordered breathing, restless leg syndrome or periodic limb movement syndrome.
  • Use of benzodiazepines or other hypnotics during the study and preceding two weeks or 5 half lives whichever is longer.
  • Known or suspected hypersensitivity to exogenous melatonin or melatonin receptor agonists
  • Use of melatonin during preceding two weeks
  • Use of psychiatric medications during the study and preceding three months.
  • History of autoimmune diseases
  • Pharmacological immuno-suppression.
  • Pregnancy or lactation, child-bearing potential with a lack of adequate contraception.
  • History of severe pathology likely to recur during or immediately after the study.
  • Participation in a clinical trial with any investigational agent within two months prior to study enrollment.
  • Patients incapable of performing the daily call to the study IVRS system and reporting on the questionnaires.
  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: NCT00972075

Locations
United States, Georgia
Sleep Disorders Center of Atlanta
Atlanta, Georgia, United States, 30382
United States, New York
Clinlabs, Inc.
New York, New York, United States, 10019
Sponsors and Collaborators
Neurim Pharmaceuticals Ltd.
Investigators
Principal Investigator: Alan Lankford, PhD Sleep Disorders Center of Atlanta
Principal Investigator: Gary Zammit, PhD Clinlabs, Inc.
  More Information

No publications provided

Responsible Party: Tali Nir, VP clinical and regulatory affairs, Neurim Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT00972075     History of Changes
Other Study ID Numbers: CIRCADIN 1
Study First Received: September 3, 2009
Last Updated: September 6, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Neurim Pharmaceuticals Ltd.:
totally blind subjects

Additional relevant MeSH terms:
Disease
Sleep Disorders, Circadian Rhythm
Chronobiology Disorders
Dyssomnias
Mental Disorders
Nervous System Diseases
Occupational Diseases
Pathologic Processes
Sleep Disorders
Melatonin
Antioxidants
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014