A DOUBLE-BLIND, PARALLEL GROUP, RANDOMISED, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CIRCADIN® 2MG IN THE IMPROVEMENT OF SLEEP QUALITY IN PATIENTS WITH INSOMNIA AGED 55-80 YEARS.
- Conditions
- Primary Insomnia in adults over 55 years
- Registration Number
- EUCTR2004-000914-37-GB
- Lead Sponsor
- eurim Pharmaceuticals (1991) Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 520
· male or female and aged 55-80 years
· suffering from primary insomnia according to DSM-IV criteria (307.42 primary
insomnia, Appendix 24.3) characterized by poor quality of sleep with or without
difficulty in initiating sleep or difficulty in maintaining sleep (Based on a Sleep
History Questionnaire that is given to the patient before Visit 1, Appendix 24.11)
· have not been using 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 3 months
· are willing to take a 6-SMT level evaluation test on the night of the visit
· are willing to sign a written informed consent to participate in the study
Patients completing the two week placebo run-in and who fulfil the following criteria will be eligible to be randomised:
· Negative drug screen (BZD and opiates)
· No reported use of BZD and non-BZD hypnotics, antihistamines or psychotropic
treatments during the two-week placebo run-in period
· A good compliance during the two-week placebo run-in period defined as 70% to
130% of prescribed tablets
· Correct use of the LSEQ and Sleep Diary
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
· Incorrect use of the Sleep Diary or of the Leeds questionnaire.
· 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 and alcoholism
· Other serious diseases that could interfere with patient assessment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method