Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs (Neu I)

This study has been completed.
Sponsor:
Information provided by:
Neurim Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT00816673
First received: December 31, 2008
Last updated: January 4, 2009
Last verified: January 2009

December 31, 2008
January 4, 2009
September 1996
May 1997   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00816673 on ClinicalTrials.gov Archive Site
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Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs
Phase II Study of Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Primary Insomnia
  • Drug: placebo Circadin
    Placebo tabs of Prolonged release melatonin
  • Drug: Circadin
    prolonged release melatonin 2 mg taken daily 2 hours before bed-time for 3 weeks
    Other Name: ATC code: N05CH01
  • Placebo Comparator: placebo
    Intervention: Drug: placebo Circadin
  • Experimental: Circadin
    Intervention: Drug: Circadin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 1997
May 1997   (final data collection date for primary outcome measure)

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.
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00816673
Neurim I
Not Provided
Tali Nir Director Clinical and Regulatory Affairs, Neurim Pharmaceuticals Ltd.
Neurim Pharmaceuticals Ltd.
Not Provided
Principal Investigator: Jean Paul MACHER, MD Forenap
Neurim Pharmaceuticals Ltd.
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP