Phase 2
Completed N=60
Study of a Neuroprotective Drug to Limit the Extent of Damage From an Ischemic Stroke
Stroke, Acute
Source: ClinicalTrials.gov NCT00630396 ↗
Enrolled (actual)
60
Serious AEs
48.3%
Results posted
Jan 2012
Primary outcomePrimary: Maximally Tolerated Dose of IV Minocycline — 10 mg/kg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximally Tolerated Dose of IV Minocycline |
10 | — |
| SECONDARY Half-life of IV Minocycline |
23.8 | — |
| SECONDARY 90 Day Modified Rankin Scale Score |
15; 15; 9; 11; 2; 3 | — |
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
Data sourced from ClinicalTrials.gov (NCT00630396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.