Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
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.

Tracking Information
First Submitted Date  ICMJE November 7, 2006
First Posted Date  ICMJE November 8, 2006
Results First Submitted Date  ICMJE August 26, 2010
Results First Posted Date  ICMJE March 28, 2011
Last Update Posted Date May 1, 2018
Study Start Date  ICMJE October 2006
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2006)
The change from baseline in subjective sleep latency.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2006)
The change from baseline in subjective sleep maintenance.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Primary Insomnia
Intervention  ICMJE
  • Drug: Circadin
    Prolonged release melatonin 2 mg
    Other Name: ATC code: N05CH01
  • Drug: placebo circadin
    placebo circadin tablets
Study Arms  ICMJE
  • Experimental: Circadin
    Intervention: Drug: Circadin
  • Placebo Comparator: placebo
    Intervention: Drug: placebo circadin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2011)
930
Original Enrollment  ICMJE
 (submitted: November 7, 2006)
600
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00397189
Other Study ID Numbers  ICMJE NEU 112006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Neurim Pharmaceuticals Ltd.
Study Sponsor  ICMJE Neurim Pharmaceuticals Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gordon M Crawford, MBChB CPS Research
PRS Account Neurim Pharmaceuticals Ltd.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP