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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00972075
Recruitment Status : Completed
First Posted : September 4, 2009
Last Update Posted : September 9, 2009
Information provided by:
Neurim Pharmaceuticals Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Non-24 Hour Sleep-Wake Disorder Blindness Drug: melatonin (Circadin) Drug: placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders
Drug Information available for: Melatonin

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Total sleep time [ Time Frame: six weeks ]

Secondary Outcome Measures :
  1. Daily diary records of sleep latency, sleep maintenance , total duration of naps; [ Time Frame: six weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00972075

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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.
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Principal Investigator: Alan Lankford, PhD Sleep Disorders Center of Atlanta
Principal Investigator: Gary Zammit, PhD Clinlabs, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Tali Nir, VP clinical and regulatory affairs, Neurim Pharmaceuticals Ltd. Identifier: NCT00972075    
Other Study ID Numbers: CIRCADIN 1
First Posted: September 4, 2009    Key Record Dates
Last Update Posted: September 9, 2009
Last Verified: September 2009
Keywords provided by Neurim Pharmaceuticals Ltd.:
totally blind subjects
Additional relevant MeSH terms:
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Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Mental Disorders
Chronobiology Disorders
Occupational Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants