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

NCT00397189 | Completed Phase 3 Results

• 1 other identifier: NEU 112006
• Study Type: interventional
• Target: 930
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Insomnia

Keywords

Primary insomnia as defined by DSM IV criteria

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and 3 weeks

Secondary Outcomes (1)

• The Change From Baseline in Subjective Sleep Maintenance.

  3 weeks

Study Arms (2)

Circadin

EXPERIMENTAL

Drug: Circadin

placebo

PLACEBO COMPARATOR

Drug: placebo circadin

Interventions

Circadin DRUG

Prolonged release melatonin 2 mg

Also known as: ATC code: N05CH01

Circadin

placebo circadin DRUG

placebo circadin tablets

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurim Pharmaceuticals Ltd.: lead

Study Sites (1)

CPS Research

Glasgow, G20 0XA, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 21091391 DERIVED

• 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.

  PMID: 20712869 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: VP clinical and regulatory affairs
• Organization: Neurim Pharmaceuticals

Talin@neurim.com

+972-3-6499340

Study Officials

• Gordon M Crawford, MBChB

  CPS Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2006
• First Posted: November 8, 2006
• Study Start: October 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: April 1, 2009
• Last Updated: May 1, 2018
• Results First Posted: March 28, 2011

Record last verified: 2018-04

Locations

GB (1)