A Phase 2 interventional study of placebo Circadin and Circadin in Primary Insomnia, sponsored by Neurim Pharmaceuticals Ltd.. Completed at 1 site in France. Open to participants aged 55 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by Neurim Pharmaceuticals Ltd. · Phase 2, Interventional, and Treatment
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.
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 with deficiency in melatonin; thus it deserves more clinical and paraclinical investigations for establishing efficacy in inducing and maintaining sleep and for safety. Since, on the one hand, the endogenous substance melatonin has beneficial effects on sleep in man and, on the other hand, there is a decrease in melatonin secretion in elderly people, substitution therapy in elderly insomniacs would be a desirable therapy.
The aim of this placebo controlled study was 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. Sleep was assessed by means of polysomnography (hypnographic results), all-night sleep EEG spectral analysis (functional and quantitative results of sleep EEG), actimetry (SomnitorTM), wake EEG and sleep/wake quality questionnaires. Vigilance and cognitive skills were assessed by means of psychomotor and neurocognitive tests derived from the Leeds psychomotor test battery (vigilance and arousal) and TEA battery (attention).
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 40 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Neurim Pharmaceuticals Ltd. is the lead sponsor of 14 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: placebo Circadin
Drug: Circadin
Placebo tabs of Prolonged release melatonin
prolonged release melatonin 2 mg taken daily 2 hours before bed-time for 3 weeks
Also known as: ATC code: N05CH01
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Neurim Pharmaceuticals Ltd.