Study of a Neuroprotective Drug to Limit the Extent of Damage From an Ischemic Stroke

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary aim of this study is to find out which of 4 different doses of minocycline are safe and well tolerated so that we will know the optimal dose to test in future patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Hess, MD
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Oregon Health and Science University; University of Kentucky
• Treatments: Minocycline

Criteria

Inclusion Criteria:

• over 18 years of age

• acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia

• onset of symptoms less than 6 hours

• measurable neurologic deficit (National Institutes of Health [NIH] Stroke Scale >/= 1)

Exclusion Criteria:

• allergy to tetracycline antibiotics

• women of child-bearing potential

• known hepatic and/or renal insufficiency

• Thrombocytopenia

• history of intolerance to minocycline

• dizziness at the time of stroke or in the past month (by self-report)

• aphasia likely to interfere with patients ability to report adverse effects

• previous functional disability

• stuporous or comatose

• presence of another serious illness likely to confound the study

• unlikely to be available for 90 day follow-up

• severe stroke (National Institutes of Health [NIH] Stroke Scale >22)

• undergoing an interventional neuro-radiological intervention in first 12 hour