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

David Hess, MD

Status and phase: Completed; Phase 2; Phase 1

Conditions: Stroke, Acute

Treatments: Drug: Minocycline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00630396

R01NS055728-01A1

07-02-202 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Minocycline is a widely used antibiotic and is approved by the Food and Drug Administration (FDA) for treatment of infections and acne. However, doctors do not know whether minocycline will work in stroke patients. Its use in stroke patients is experimental. There is a lot of information from experimental stroke studies in animals that minocycline lessens the damage from a stroke and the animals recover better. Since minocycline is generally a very safe drug in humans and does not have a lot of side effects, investigators at Georgia Health Sciences University (formerly the Medical College of Georgia) believe that it might be a safe and effective drug to improve the outcome in patients with stroke.

Enrollment: 60 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)