Safety Study of Melatonin in Stroke Patients

Phase 4

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Melatonin; Drug: placebo

• Registration Number: NCT01863277
• Lead Sponsor: Wolfson Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2013-04
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-05-24
• Last Update Submitted: 2013-05-24
• Study First Posted: 2013-05-27
• Last Update Posted: 2013-05-27
• Study Start: 2013-07
• Primary Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin	Melatonin	Melatonin 14mg/daily given over 14 days
sugar pill	placebo	sugar pill given over 14 days

Primary Outcome Measures

Name	Time	Method
Improvement of at least one point on the MRS score	3 months

Trial Locations

Locations (1)

E. Wolfson Medical Center; 🇮🇱 Holon, Israel