A Double Blind, Placebo Controlled Study to Evaluate the Efficacy of Melatonin in Acute Ischemic Stroke.
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Wolfson Medical Center
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Improvement of at least one point on the MRS score
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Melatonin
Melatonin 14mg/daily given over 14 days
Intervention: Melatonin (Drug)
sugar pill
sugar pill given over 14 days
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Improvement of at least one point on the MRS score
Time Frame: 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Yair Lampl
Prof. Yair Lampl
Wolfson Medical Center