- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01863277
Safety Study of Melatonin in Stroke Patients
May 24, 2013 updated by: Dr. Yair Lampl, Wolfson Medical Center
A Double Blind, Placebo Controlled Study to Evaluate the Efficacy of Melatonin in Acute Ischemic Stroke.
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
140
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Holon, Israel, 58100
- E. Wolfson Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Melatonin
Melatonin 14mg/daily given over 14 days
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Placebo Comparator: sugar pill
sugar pill given over 14 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement of at least one point on the MRS score
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Anticipated)
April 1, 2014
Study Registration Dates
First Submitted
May 22, 2013
First Submitted That Met QC Criteria
May 24, 2013
First Posted (Estimate)
May 27, 2013
Study Record Updates
Last Update Posted (Estimate)
May 27, 2013
Last Update Submitted That Met QC Criteria
May 24, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Stroke
- Ischemic Stroke
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Protective Agents
- Antioxidants
- Melatonin
Other Study ID Numbers
- 0130-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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