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

NCT ID: NCT00630396

Last Updated: 2012-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-01-31

Brief 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.

Detailed 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.

Conditions

Stroke, Acute

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Minocycline

Dose level 1 = 3mg/kg intravenous (IV) initial dose, followed by 1.5mg/kg every 12 hours times 5 more doses.

Dose level 2 = 4.5mg/kg intravenous (IV) initial dose, followed by 2.25mg/kg every 12 hours times 5 more doses.

Dose level 3 = 6 mg/kg intravenous (IV) initial dose, followed by 3 mg/kg every 12 hours times 5 more doses.

Dose level 4 = 10 mg/kg intravenous (IV) initial dose, followed by 5 mg/kg every 12 hours times 5 more doses

Intervention Type: DRUG

Other Intervention Names

Minomycin; Minocycline hydrochloride; Minocycline hydrochloride injection; Minomycin Intravenous (for drip use); Minomycin Intravenous; MINO

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of Kentucky

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

David Hess, MD

OTHER

Sponsor Role: lead

Responsible Party

David Hess, MD

Professor and Chairman

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David C Hess, MD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

University of Kentucky

Lexington, Kentucky, United States

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

References

Fagan SC, Waller JL, Nichols FT, Edwards DJ, Pettigrew LC, Clark WM, Hall CE, Switzer JA, Ergul A, Hess DC. Minocycline to improve neurologic outcome in stroke (MINOS): a dose-finding study. Stroke. 2010 Oct;41(10):2283-7. doi: 10.1161/STROKEAHA.110.582601. Epub 2010 Aug 12.

Reference Type: RESULT

PMID: 20705929 (View on PubMed)

Other Identifiers

07-02-202

Identifier Type: OTHER

Identifier Source: secondary_id

R01NS055728-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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