Loading clinical trials...

COMPLETEDPHASE2

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

A Double-Blind, Placebo-Controlled Study of Circadin™ for Non-24 Hour Sleep-Wake Disorder in Totally Blind Subjects

NCT00972075•Neurim Pharmaceuticals Ltd.

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.

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

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (2)

Sleep Disorders Center of Atlanta

Atlanta, Georgia, United States

Clinlabs, Inc.

New York, New York, United States

Key Dates

Start Date

February 1, 2006

Primary Completion Date

August 1, 2007

Completion Date

October 1, 2007

Last Updated

September 9, 2009

Enrollment

ACTUAL participants

Conditions

Non-24 Hour Sleep-Wake DisorderBlindness

Interventions

melatonin (Circadin)

DRUG

placebo

DRUG

Mechanisms of Visual Restoration After Occipital Stroke

NCT07134777

Cortical BlindnessStroke Ischemic+5 more

View study

RECRUITING

Holistic Mixed Approaches to Capture the Real Life of Children With Rare Eye Diseases

NCT06070467

Eye DiseasesSevere Loss of Vision+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 9, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Mechanisms of Visual Restoration After Occipital Stroke

Holistic Mixed Approaches to Capture the Real Life of Children With Rare Eye Diseases

Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis

MySpace: the Role of Vision in Representing Space

Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers

Eye Health Intervention Study in Upper Manhattan