Minocycline Treatment in Acute Hemorrhagic Stroke

• Conditions: Poor Performance Status

• Registration Number: NCT01388127
• Lead Sponsor: Wolfson Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2011-06
• Study Start: 2011-07
• Study First Submitted: 2011-07-03
• Study First Submitted QC: 2011-07-05
• Last Update Submitted: 2011-07-05
• Study First Posted: 2011-07-06
• Last Update Posted: 2011-07-06
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Edith Wolfson Medical Center; 🇮🇱 Holon, Israel