Primary Insomnia in adults over 55 years
Conditions
Interventions
Product Name: CIRCADIN ®
Product Code: N/A
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administratio
Sponsors
Neurim Pharmaceuticals (1991) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · 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
Exclusion criteria
Exclusion criteria: · 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare, by the end of the 3 weeks treatment period, the rate of patients in the Circadin® (2 mg) and placebo-treated groups improving by 10 mm or more on the QOS and BFW variables of the LSEQ, in patients with primary insomnia aged 55-80. ; Secondary Objective: To compare by the end of the 3 weeks treatment period, vs. placebo the effects of Circadin® 2 mg: 1. on all parameters derived from the Leeds SEQ: on the global score of the PSQI: on QON and QOD derived from the Diary and on Clinical Global Impression Scale score derived from the Clinical General Impression Score (CGIS). 2. in patients with low endogenous melatonin (defined as urinary excretion of the major melatonin metabolite 6 sulphatoxymelatonin (6 SMT) of 7 mg 6-SMT on the global score of the PSQI and all other parameters identified under point 1. 4. To assess safety parameters ;Primary end point(s): The primary efficacy endpoint in this study for the EMEA, is responder rate (defined by improvement of at least 10 mm from baseline to end of the three-week treatment period in both the QOS and BFW variables, as derived as the means of Questions 4, 5 and of Questions 8, 9, 10 of the LSEQ respectively). | — |
Countries
United Kingdom
Outcome results
None listed