NCT00397189

Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients

A Double-blind, Parallel Group, Randomised, Placebo Controlled Study of Efficacy and Safety of Circadin® 2 mg in the Treatment of Insomnia Patients With Low Endogenous Melatonin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 930 (actual)
• Sponsor: Neurim Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomised, placebo controlled study to evaluate the efficacy of a 3 week treatment period with Circadin® 2 mg in shortening sleep latency in patients with primary insomnia aged 18-80 with melatonin deficiency.

Detailed description

Studies throughout the world have shown that insomnia is a common complaint that occurs in 10-50% of the population depending on age, sex and country. Among the wide variety of available treatments of sleep disturbances, the most commonly prescribed hypnotics are the benzodiazepines (BZD) and non-BZD hypnotics. However, these hypnotics were often associated with rebound, dependency, tolerance, higher risk of falls mainly in the elderly population, anterograde memory disturbances and increased risk for motor accidents the next day. In response to the unmet clinical need for a safe and efficacious alternative treatment for primary insomnia, that in addition to treating quantitative sleep problems, would improve sleep quality and daytime functioning, a clinical development program on melatonin for the treatment of primary insomnia was initiated. This study is conducted using a randomised, double-blind, placebo controlled parallel group design, after a single-blind placebo period. Primary insomnia patients aged 18-80 will be screened for entry into the study. After the initial 3 weeks double-blind treatment period, patients will be given the option to enter a six-month double-blind continuation study. Primary parameter is sleep latency, secondary parameter is sleep maintenance. Exploratory parameters are total sleep time, sleep quality, morning alertness and quality of life.

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
DRUG	Circadin	Prolonged release melatonin 2 mg
DRUG	placebo circadin	placebo circadin tablets

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-12-01
• Completion: 2009-04-01
• First posted: 2006-11-08
• Last updated: 2018-05-01
• Results posted: 2011-03-28

Locations

1 site across 1 country: United Kingdom