This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

HomeBrowseAboutFAQs
Log In
Sign Up
Primary Insomnia

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

Sponsored by Neurim Pharmaceuticals Ltd.

About this trial

Last updated 7 years ago

Study ID

NEU 112006

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18 to 80 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 16 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status