Safety Study of Melatonin in Stroke Patients

Acute Ischemic Stroke Clinical Trial

Official title:

A Double Blind, Placebo Controlled Study to Evaluate the Efficacy of Melatonin in Acute Ischemic Stroke.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01863277
• Other study ID #: 0130-12
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 22, 2013
• Last updated: May 24, 2013
• Start date: July 2013

Study information

• Verified date: April 2013
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the effect of Melatonin (in a dosage of 14mg daily) for a better clinical outcome in the period three days post stroke.

Description:

Stroke is the third most common cause of stroke. The cascade of event is separated into hyperacute,,acute,sub-acute and chronic. In the acute, sub acute state there are mechanisms of inflammation apoptotic death and effect of free radicals. Melatonin was proved to effect these mechanisms and to have a favourable effect in different diseases. The aim of the study is to prove That the use of Melatonin in a higher dosage may have a anti-destructive effect in stoke.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• within 72hours of ischemic stroke

• age 18-80

• both gender

• ability to sign consent form

Exclusion Criteria:

• intra-cerebral bleeding

• tumour of brain

• multiple sclerosis

• s/p craniotomy

• known allergy to melatonin

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Stroke

Intervention

Drug:
• Melatonin

• placebo

Locations

Country	Name	City	State
Israel	E. Wolfson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of at least one point on the MRS score		3 months	No