Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients

April 29, 2018 updated by: Neurim Pharmaceuticals Ltd.

A Double-blind, Parallel Group, Randomised, Placebo Controlled Study of Efficacy and Safety of Circadin® 2 mg in the Treatment of Insomnia Patients With Low Endogenous Melatonin

This is a randomised, placebo controlled study to evaluate the efficacy of a 3 week treatment period with Circadin® 2 mg in shortening sleep latency in patients with primary insomnia aged 18-80 with melatonin deficiency.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Studies throughout the world have shown that insomnia is a common complaint that occurs in 10-50% of the population depending on age, sex and country. Among the wide variety of available treatments of sleep disturbances, the most commonly prescribed hypnotics are the benzodiazepines (BZD) and non-BZD hypnotics.

However, these hypnotics were often associated with rebound, dependency, tolerance, higher risk of falls mainly in the elderly population, anterograde memory disturbances and increased risk for motor accidents the next day.

In response to the unmet clinical need for a safe and efficacious alternative treatment for primary insomnia, that in addition to treating quantitative sleep problems, would improve sleep quality and daytime functioning, a clinical development program on melatonin for the treatment of primary insomnia was initiated.

This study is conducted using a randomised, double-blind, placebo controlled parallel group design, after a single-blind placebo period. Primary insomnia patients aged 18-80 will be screened for entry into the study.

After the initial 3 weeks double-blind treatment period, patients will be given the option to enter a six-month double-blind continuation study.

Primary parameter is sleep latency, secondary parameter is sleep maintenance. Exploratory parameters are total sleep time, sleep quality, morning alertness and quality of life.

Study Type

Interventional

Enrollment (Actual)

930

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female and aged 18-80 years.
  • Are willing to take a 6-SMT level evaluation test.
  • Suffering from primary insomnia according to DSM-IV. criteria (307.42 primary insomnia, Appendix 24.3) .
  • Sleep latency of at least 20 minutes.
  • Have not been using benzodiazepines (BZD) and non-BZD hypnotics for the past 2 weeks or more.
  • Have not been using psychotropic treatments for the past 3 months or more.
  • Are stabilized on non-psychotropic treatments for more than 1 month.
  • Are willing to sign a written informed consent to participate in the study.

Exclusion Criteria:

  • Use of benzodiazepines or other hypnotics (including psychotropic treatments) during the study and preceding two weeks.
  • Alcohol intake more than 30 g of pure alcohol per day and any intake after lunch-time.
  • Pharmacological immunosuppression.
  • Participation in a clinical trial with any investigational agent within two months prior to study enrollment.
  • According to DSM IV, subjects belonging to the following groups are excluded: 780.59 (breathing related sleep disorder); 307.45 (circadian rhythm sleep disorder); 307.47 (dyssomnia not otherwise specified); 780.xx (sleep disorder due to general medical condition).
  • Severe neurological, psychiatric disorders (especially psychosis, anxiety and depression) and alcoholism.
  • Other serious diseases that could interfere with patient assessment.
  • Pregnant or breast feeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo circadin
placebo circadin tablets
Experimental: Circadin
Drug: Circadin
Prolonged release melatonin 2 mg
Other Names:
  • ATC code: N05CH01

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change From Baseline in Subjective Sleep Latency.
Time Frame: Baseline and 3 weeks
Sleep latency (SL) after 3 weeks of treatment was assessed by Patient Daily Sleep Diary (National sleep foundation sleep diary). The patients reported subjectively of their SL. The Sleep Diary question 3 (SL) was summarised at baseline (end of the two-week run-in period) and after three weeks double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. At each visit, the mean of the seven days prior to the visit were used. For each treatment group, the mean score at visit 3 was compared, adjusting for the visit 2 score. An ANCOVA model was used. Lower score indicates reduction in sleep latency and thus considered improvement
Baseline and 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change From Baseline in Subjective Sleep Maintenance.
Time Frame: 3 weeks
Sleep maintenance as measured by number of awakening (NOA) after 3 weeks of treatment was assessed by Patient Daily Sleep Diary (National sleep foundation sleep diary). The patients reported subjectively of their NOA. The Sleep Diary question 4 (NOA) was summarized at baseline (end of the two-week run-in period) and after three weeks double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. At each visit, the mean of the seven days prior to the visit were used. For each treatment group, the mean score at visit 3 was compared, adjusting for the visit 2 score. An ANCOVA model was used. Lower score indicates less awakenings and thus considered improvement.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurim Pharmaceuticals Ltd.

Investigators

  • Principal Investigator: Gordon M Crawford, MBChB, CPS Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

November 7, 2006

First Submitted That Met QC Criteria

November 7, 2006

First Posted (Estimate)

November 8, 2006

Study Record Updates

Last Update Posted (Actual)

May 1, 2018

Last Update Submitted That Met QC Criteria

April 29, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEU 112006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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