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Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs

NCT00816673 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-11-14

No results posted yet for this study

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.

Conditions

  • Primary Insomnia

Interventions

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

Sponsors & Collaborators

  • Neurim Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Jean Paul MACHER, MD · Forenap

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-09-30
Primary Completion
1997-05-31
Completion
1997-09-30

Countries

  • France

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00816673 on ClinicalTrials.gov