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

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ClinicalTrials.gov Identifier: NCT00397189
Recruitment Status : Completed
First Posted : November 8, 2006
Results First Posted : March 28, 2011
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Neurim Pharmaceuticals Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Insomnia Drug: Circadin Drug: placebo circadin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 930 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Circadin Drug: Circadin
Prolonged release melatonin 2 mg
Other Name: ATC code: N05CH01

Placebo Comparator: placebo Drug: placebo circadin
placebo circadin tablets




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT00397189


Locations
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United Kingdom
CPS Research
Glasgow, United Kingdom, G20 0XA
Sponsors and Collaborators
Neurim Pharmaceuticals Ltd.
Investigators
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Principal Investigator: Gordon M Crawford, MBChB CPS Research
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Neurim Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT00397189    
Other Study ID Numbers: NEU 112006
First Posted: November 8, 2006    Key Record Dates
Results First Posted: March 28, 2011
Last Update Posted: May 1, 2018
Last Verified: April 2018
Keywords provided by Neurim Pharmaceuticals Ltd.:
Primary insomnia as defined by DSM IV criteria
Additional relevant MeSH terms:
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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