Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs

Primary Insomnia Clinical Trial

— Neu I  

Official title:

Phase II Study of Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816673
• Other study ID #: Neurim I
• Status: Completed
• Phase: Phase 2
• First received: December 31, 2008
• Last updated: January 4, 2009
• Start date: September 1996
• Est. completion date: September 1997

Study information

• Verified date: January 2009
• Source: Neurim Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 1997
• Est. primary completion date: May 1997
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Healthy male and female, aged = 55 years, suffering from primary insomnia according to DSM-IV criteria (307.42)

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary Insomnia

Intervention

Drug:
• placebo Circadin
Placebo tabs of Prolonged release melatonin
• Circadin
prolonged release melatonin 2 mg taken daily 2 hours before bed-time for 3 weeks

Locations

Country	Name	City	State
France	FORENAP	Centre Hospitalier de Rouffach

Sponsors (1)

Lead Sponsor	Collaborator
Neurim Pharmaceuticals Ltd.

Country where clinical trial is conducted

France,