Back to resultsSafety Study of Melatonin in Stroke Patients
Primary Purpose
Acute Ischemic Stroke
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Melatonin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke
Eligibility Criteria
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
Sites / Locations
- E. Wolfson Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Melatonin
sugar pill
Arm Description
Melatonin 14mg/daily given over 14 days
sugar pill given over 14 days
Outcomes
Primary Outcome Measures
Improvement of at least one point on the MRS score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01863277
Brief Title
Safety Study of Melatonin in Stroke Patients
Official Title
A Double Blind, Placebo Controlled Study to Evaluate the Efficacy of Melatonin in Acute Ischemic Stroke.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wolfson Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Melatonin
Arm Type
Active Comparator
Arm Description
Melatonin 14mg/daily given over 14 days
Arm Title
sugar pill
Arm Type
Placebo Comparator
Arm Description
sugar pill given over 14 days
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Improvement of at least one point on the MRS score
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
E. Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yair Lampl, Prof
Phone
+972-3-5028513
Email
y_lampl@hotmail.com
First Name & Middle Initial & Last Name & Degree
Mary Israelson
Phone
+972-507-704618
Email
maryisraelson@gmail.com
First Name & Middle Initial & Last Name & Degree
Yair Lampl, Prof
12. IPD Sharing Statement
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Safety Study of Melatonin in Stroke Patients
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