Safety Study of Melatonin in Stroke Patients

• Sponsor: Wolfson Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01863277
• Collaborator: (none)
• Enrollment: 140
• Location: 1
• Arms: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Drug: Melatonin; Drug: placebo	Phase 4

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
• Anticipated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double Blind, Placebo Controlled Study to Evaluate the Efficacy of Melatonin in Acute Ischemic Stroke.
• Study Start Date: Jul 1, 2013
• Anticipated Primary Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Melatonin Melatonin 14mg/daily given over 14 days	Drug: Melatonin
Placebo Comparator: sugar pill sugar pill given over 14 days	Drug: placebo

Outcome Measures

Primary Outcome Measures

1. Improvement of at least one point on the MRS score [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	E. Wolfson Medical Center	Holon		Israel	58100

Sponsors and Collaborators

• Wolfson Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Yair Lampl, Prof. Yair Lampl, Wolfson Medical Center
• ClinicalTrials.gov Identifier: NCT01863277
• Other Study ID Numbers: 0130-12
• First Posted: May 27, 2013
• Last Update Posted: May 27, 2013
• Last Verified: Apr 1, 2013

• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Melatonin

Study Results

No Results Posted as of May 27, 2013