Phase 3
N=789
Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients
Primary Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT00397189 ↗Enrolled (actual)
789
Serious AEs
0.5%
Results posted
Mar 2011
Primary outcome: Primary: The Change From Baseline in Subjective Sleep Latency. — -19.1; -1.7 minutes — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Circadin (Drug); placebo circadin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Neurim Pharmaceuticals Ltd.
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change From Baseline in Subjective Sleep Latency. |
-19.1; -1.7 | <0.05 sig |
| SECONDARY The Change From Baseline in Subjective Sleep Maintenance. |
-0.24; -0.09 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00397189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.