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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurim Pharmaceuticals Ltd.
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• Male or female and aged 18-80 years.

• Are willing to take a 6-SMT level evaluation test.

• Suffering from primary insomnia according to DSM-IV. criteria (307.42 primary insomnia, Appendix 24.3) .

• Sleep latency of at least 20 minutes.

• Have not been using benzodiazepines (BZD) and non-BZD hypnotics for the past 2 weeks or more.

• Have not been using psychotropic treatments for the past 3 months or more.

• Are stabilized on non-psychotropic treatments for more than 1 month.

• Are willing to sign a written informed consent to participate in the study.

Exclusion Criteria:

• Use of benzodiazepines or other hypnotics (including psychotropic treatments) during the study and preceding two weeks.

• Alcohol intake more than 30 g of pure alcohol per day and any intake after lunch-time.

• Pharmacological immunosuppression.

• Participation in a clinical trial with any investigational agent within two months prior to study enrollment.

• According to DSM IV, subjects belonging to the following groups are excluded: 780.59 (breathing related sleep disorder); 307.45 (circadian rhythm sleep disorder); 307.47 (dyssomnia not otherwise specified); 780.xx (sleep disorder due to general medical condition).

• Severe neurological, psychiatric disorders (especially psychosis, anxiety and depression) and alcoholism.

• Other serious diseases that could interfere with patient assessment.

• Pregnant or breast feeding women.