Text Size

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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

Drug Information available for: Melatonin
U.S. FDA Resources

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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 31, 2008
Last Updated: January 4, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 Disorders
Nervous System Diseases
Mental Disorders
Melatonin
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013