Minocycline Treatment in Acute Hemorrhagic Stroke

Poor Performance Status Clinical Trial

— Minocycline  

Official title:

Minocycline Treatment in Acute Hemorrhagic Stroke for Evaluation of Treatment Efficacy and Blood Brain Barrier Permeability

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01388127
• Other study ID #: 0048-11 WOMC
• Status: Not yet recruiting
• Phase: N/A
• First received: July 3, 2011
• Last updated: July 5, 2011
• Start date: July 2011
• Est. completion date: July 2012

Study information

• Verified date: June 2011
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The investigators will perform a double blind controlled study to investigate the efficacy of oral administration of 200 mg minocycline, on the neurological and functional outcome after acute hemorrhagic stroke and the effect on blood brain barrier permeability.

Description:

Minocycline, a semisynthetic second generation derivative of tetracycline, was shown to have a clear beneficial neuroprotective effect in animal models of multiple sclerosis, Parkinson's disease, Huntington's disease and amyotrophic lateral sclerosis. Animal models provide promising evidence of minocycline's ability to improve outcomes in an animal stroke model.

In light of these findings, we will perform a double blind controlled study to investigate the efficacy of oral administration of 200 mg minocycline, on the neurological and functional outcome after acute hemorrhagic stroke and the effect on blood brain barrier permeability.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with acute hemorrhagic stroke

1. age > 18

2. NIHSS score > 5

3. onset of stroke 6 to 24 hours prior to beginning of treatment. Patients, who arrived within 0 to 6 hours post stroke, were treated with other medications according to the best accepted medical treatment guidelines.

Exclusion Criteria:

1. Evidence of other disease of the central nervous system, including brain tumor, demyelinating disease, inflammatory disease of the central nervous system, craniotomy in the past, severe brain injuries and benign intracranial hypertension

2. pre-existing neurological disability

3. known allergic response to tetracyclines

4. acute or chronic renal failure

5. pre-existing infectious disease requiring antibiotic therapy

6. swallowing difficulties

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Poor Performance Status

Locations

Country	Name	City	State
Israel	Edith Wolfson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel,