Status:
COMPLETED
Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients
Lead Sponsor:
Neurim Pharmaceuticals Ltd.
Conditions:
Primary Insomnia
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 m...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
930 Patients enrolled
Trial Details
Trial ID
NCT00397189
Start Date
October 1 2006
End Date
April 1 2009
Last Update
May 1 2018
Active Locations (1)
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1
CPS Research
Glasgow, United Kingdom, G20 0XA