Minocycline treatment in acute stroke
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Status:
Completed. Results published October 2007.
Purpose:
To analyze the effect of minocycline treatment of acute ischemic stroke patients.
Interventions:
Minocycline
Minocycline is a member of the broad spectrum tetracycline antibiotics, and has a broader spectrum than the other members. It is a bacteriostatic antibiotic.
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Year Started:
2003
Year Finished:
2005
Design:
Open-label, randomized, controlled, evaluator-blinded study.
Inclusion Criteria
NIHSS score >5; onset of stroke 6 to 24 hours prior to beginning of treatment.
Exclusion Criteria
Patients with onset of stroke from 0 to 6 hours; hemorrhagic stroke; evidence of other disease of the CNS, including brain tumor, demyelinating disease, inflammatory disease of the CNS, craniotomy in the past, severe brain injuries, and idiopathic intracranial hypertension; pre-existing neurologic disability; known allergic response to tetracyclines; acute or chronic renal failure; pre-existing infectious disease requiring antibiotic therapy; and swallowing difficulties.
Patient Involvement:
Patients were randomized according to their 8th number on their identity card. Treatment of 200 mg/day minocycline or placebo was given for 5 consecutive days. The neurologic deficits, global functional abilities, and the level of handicap were scored using the NIH Stroke Scale (NIHSS) findings, Barthel Index (BI), and modified Rankin Scale (mRS) score at baseline on days 7, 30 and 90.
Primary Outcome:
NIH Stroke Scale (NIHSS) scores on day 90.
Secondary Outcome:
NIHSS scores on day 7 and day 30, as well as modified Rankin Scale (mRS) and Barthel Index (BI) scores on day 7, day 30, and day 90. Favorable outcome was defined as NIHSS 0 to 1 on day 90.
Results:
NIH Stroke Scale (NIHSS) scores at day 90 were significantly lower in minocycline vs placebo-treated patients (1.6 +/- 1.9 vs 6.5 +/- 3.8, p < 0.0001). NIHSS scores favored the treatment group from day 1, with day 7 (6.5 +/- 3.8 vs 8.1 +/- 4.4, p < 0.0001) and day 30 (1.8 +/- 2.1 vs 7.1 +/- 4.4, p < 0.0001). Modified Rankin Scale (mRS) on day 7 for treatment group 1.5 +/- 1.4 vs placebo group 3.1 +/- 1.3; on day 30 (1.1 +/- 1.2 vs 2.7 +/- 1.3); and day 90 (0.9 +/- 1.1 vs 2.1 +/- 1.2). Barthel Index (BI) scores showed similar results with day 7 (85.9 +/- 22.3 vs 61.9 +/- 30.8), day 30 (90.6 +/- 19.1 vs 69.5 +/- 26.6) and day 90 (94.9 +/- 12.5 vs 77.6 +/- 24.0).
Seventy-four patients received minocycline treatment, and 77 received placebo. Time to treatment with minocycline was an average of 12.64 hours: 28 patients received treatment between 6 and 9 hours, 20 between 10 and 12 hours, 7 between 13 and 15 hours, 5 between 16 and 18 hours, 6 between 19 and 21 hours, and 8 between 22 and 24 hours. Time to treatment with placebo was an average of 11.99 hours. Fourteen of the study patients (5 minocycline-treated subjects and 9 control subjects) died during follow-up, none were lost to follow-up and no one dropped out.
Source of Information:
Neurology 2007;69:1404–1410.
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This information last updated on: 8/14/2008
Reviewed on: 08/14/2008.
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