Primary insomnia in adults with low endegenous melatonin.
Conditions
Interventions
Product Name: CIRCADIN
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Neurim Pharmaceuticals (1991) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • male or female and aged 18-80 years • 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) (Based on a Sleep History Questionnaire that is given to the patient before Visit 1, Appendix 24.9) • sleep latency of at least 20 minutes • 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 1 month • are willing to sign a written informed consent to participate in the study Patients completing the two week placebo baseline/screening who continue to meet the entry criteria and who fulfill the following will be eligible to be randomisedrandomized if: • Negative drug screen (BZD or opiates). Where the patient has reported use of opiate analgesics for pain relief (not hypnosis) at visit 1 the opiate screen may be positive and the patient still randomised. • No reported use of BZD and non-BZD hypnotics, antihistamines or psychotropic treatments during the two-week placebo baseline/screening period • A good compliance during the two-week placebo baseline/screening period defined as 70% to 130% of prescribed tablets • Correct use of the Diary and Leeds SEQ 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: EU Version To assess the sustained long-term efficacy of Circadin 2 mg vs placebo for up to six months of treatment as assessed by changes from baseline in subjective sleep quality (as measured by the mean PSQI global score) during visits 6 and 7 (mean value) in all patients aged 55-80. US Version Following three weeks treatment with Circadin® 2 mg or placebo, to compare the change from baseline in subjective sleep latency (as measured by the sleep diary, question 3) in “low excretors”.;Secondary Objective: EU Version In all patients aged 55-80 to compare: -change from baseline in mean subjective sleep latency (as measured by question 2 of the PSQI at visits 6, 7). -change from baseline in quality of life (as measured by the WHO-5 scale at visits 6, 7). -Clinical Global Impressions (CGI) global improvement at visits 6 and 7. -To assess withdrawal effect after discontinuation (as measured by the Tyrer scale) of Circadin vs placebo following 6 months of treatment. US Version Following three weeks treatment with Circadin® 2 mg or placebo, to compare: -change from baseline in subjective sleep latency (Sleep Diary, question 3) patients aged 65-80 inclusive. -change from baseline in “low excretors” compared to “high excretors” on efficacy variables in different age bands -the rate of responders in patients aged 55 to 80 -To assess safety parameters in the total population following three weeks treatment;Primary end point(s): EU Version To assess the sustained long-term efficacy of Circadin 2 mg vs placebo for up to six months of treatment as assessed by changes from baseline in subjective sleep quality (as measured by the mean PSQI global score) during visits 6 and 7 (mean value) in all patients aged 55-80. US Version Following three weeks treatment with Circadin® 2 mg or placebo, comparison of the change from baseline in subjective sleep latency (as measured by the Sleep Diary, question 3) in “low excretors”. | — |
Countries
United Kingdom
Outcome results
None listed