Status:
COMPLETED
Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs
Lead Sponsor:
Neurim Pharmaceuticals Ltd.
Conditions:
Primary Insomnia
Eligibility:
All Genders
55-70 years
Phase:
PHASE2
Brief Summary
The aim of this placebo controlled study is to investigate the effect of 2 mg melatonin Slow Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years or more.
Detailed Description
Circadin® is a newly developed slow release galenic formulation of melatonin, producing overall levels of melatonin comparable to those observed in a control population, when administered to patients ...
Eligibility Criteria
Inclusion
- Healthy male and female, aged ≥ 55 years, suffering from primary insomnia according to DSM-IV criteria (307.42)
Exclusion
- According to DSM-IV, subjects belonging to the following groups are excluded: 780.59; 307.45; 307.47; 780.xx (Appendix 2);
- Use of benzodiazepines or other hypnotics during the preceding 1 month with a frequency of more than 2 times a week and lasting more than 2 weeks;
- Severe neurological, psychiatric or sleep disorders;
- Other serious diseases;
- Taking more than 1/2 l of alcohol, more than 3 cups of coffee or more than 10 cigarettes per day .
- Subjects who need beta blockers as a treatment.
Key Trial Info
Start Date :
September 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 1997
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00816673
Start Date
September 1 1996
End Date
September 1 1997
Last Update
November 14 2024
Active Locations (1)
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1
FORENAP
Centre Hospitalier de Rouffach, France, F-68250