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

Primary Purpose

Primary Insomnia

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Circadin
placebo circadin
Sponsored by
Neurim Pharmaceuticals Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Insomnia focused on measuring Primary insomnia as defined by DSM IV criteria

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CPS Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Circadin

placebo

Arm Description

Outcomes

Primary Outcome Measures

The Change From Baseline in Subjective Sleep Latency.
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

The Change From Baseline in Subjective Sleep Maintenance.
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.

Full Information

First Posted
November 7, 2006
Last Updated
April 29, 2018
Sponsor
Neurim Pharmaceuticals Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00397189
Brief Title
Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients
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 Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurim Pharmaceuticals Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia
Keywords
Primary insomnia as defined by DSM IV criteria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
930 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Circadin
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Circadin
Other Intervention Name(s)
ATC code: N05CH01
Intervention Description
Prolonged release melatonin 2 mg
Intervention Type
Drug
Intervention Name(s)
placebo circadin
Intervention Description
placebo circadin tablets
Primary Outcome Measure Information:
Title
The Change From Baseline in Subjective Sleep Latency.
Description
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
Time Frame
Baseline and 3 weeks
Secondary Outcome Measure Information:
Title
The Change From Baseline in Subjective Sleep Maintenance.
Description
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.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon M Crawford, MBChB
Organizational Affiliation
CPS Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
CPS Research
City
Glasgow
ZIP/Postal Code
G20 0XA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21091391
Citation
Wade AG, Crawford G, Ford I, McConnachie A, Nir T, Laudon M, Zisapel N. Prolonged release melatonin in the treatment of primary insomnia: evaluation of the age cut-off for short- and long-term response. Curr Med Res Opin. 2011 Jan;27(1):87-98. doi: 10.1185/03007995.2010.537317. Epub 2010 Nov 24.
Results Reference
derived
PubMed Identifier
20712869
Citation
Wade AG, Ford I, Crawford G, McConnachie A, Nir T, Laudon M, Zisapel N. Nightly treatment of primary insomnia with prolonged release melatonin for 6 months: a randomized placebo controlled trial on age and endogenous melatonin as predictors of efficacy and safety. BMC Med. 2010 Aug 16;8:51. doi: 10.1186/1741-7015-8-51.
Results Reference
derived

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

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