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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00816673
First Posted: January 5, 2009
Last Update Posted: January 6, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Neurim Pharmaceuticals Ltd.
  Purpose
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.

Condition Intervention Phase
Primary Insomnia Drug: placebo Circadin Drug: Circadin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study of Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs.

Resource links provided by NLM:


Further study details as provided by Neurim Pharmaceuticals Ltd.:

Enrollment: 40
Study Start Date: September 1996
Study Completion Date: September 1997
Primary Completion Date: May 1997 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: placebo Circadin
Placebo tabs of Prolonged release melatonin
Experimental: Circadin Drug: Circadin
prolonged release melatonin 2 mg taken daily 2 hours before bed-time for 3 weeks
Other Name: ATC code: N05CH01

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 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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816673


Locations
France
FORENAP
Centre Hospitalier de Rouffach, France, F-68250
Sponsors and Collaborators
Neurim Pharmaceuticals Ltd.
Investigators
Principal Investigator: Jean Paul MACHER, MD Forenap
  More Information

Responsible Party: Tali Nir Director Clinical and Regulatory Affairs, Neurim Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT00816673     History of Changes
Other Study ID Numbers: Neurim I
First Submitted: December 31, 2008
First Posted: January 5, 2009
Last Update Posted: January 6, 2009
Last Verified: January 2009

Keywords provided by Neurim Pharmaceuticals Ltd.:
Insomnia
Primary insomnia
sleep latency
non restorative sleep
sleep quality
Double-Blind
Placebo Controlled
Parallel-Group
Sleep Laboratory Study

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants