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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary: 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.
Sponsor: Neurim Pharmaceuticals Ltd.

Current Primary Outcome: Total sleep time [ Time Frame: six weeks ]

Original Primary Outcome: Total sleep time

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

Original Secondary Outcome: Daily diary records of sleep latency, sleep maintenance , total duration of naps;

Information By: Neurim Pharmaceuticals Ltd.

Dates:
Date Received: September 3, 2009
Date Started: February 2006
Date Completion:
Last Updated: September 6, 2009
Last Verified: September 2009