Neuroprotection With Minocycline Therapy for Acute Stroke Recovery Trial (NeuMAST)
Background: Stroke is a leading cause of death and chronic serious disability worldwide.
Minocycline, a semisynthetic tetracycline, has consistently been shown in recent years to be neuroprotective in animal models of brain ischemia. Furthermore, a small, open label study done in humans with acute ischemic stroke published late last year showed that minocycline, when administered for 5 days, within 6 to 24 hours after stroke onset was highly effective in improving functional outcome even as early as 7 days after stroke onset. However, further well-conducted, randomized controlled translational studies using minocycline are currently lacking.
Objective: To determine if minocycline, administered within 3 to 48 hours after acute ischemic stroke onset is superior to placebo in reducing neurological deficit and improving functional outcome at 90 days post stroke.
Methods: The investigators plan to do a multi-centre randomized, double-blind, placebo controlled trial in which ischemic stroke patients will be randomized to treatment with either oral minocycline or placebo within 3 to 48 hours of symptom onset. The primary efficacy endpoint will be the modified Rankin scale (mRS) score for all randomized subjects at 90 days.
Secondary endpoints will include improvement of the NIH Stroke Scale (NIHSS) score from baseline and Barthel index at 90 days.
NeuMAST will test the following hypotheses:
Primary Hypothesis: Minocycline, compared with placebo, when administered between 3 to 48 hours after the onset of acute ischemic stroke improves recovery and functional outcome as assessed by mRS scores on day 90 post-stroke.
- Minocycline compared to placebo, when administered between 3 to 48 hours after onset of acute ischemic stroke improves recovery and functional outcome as assessed by improvement of NIHSS score on day 90 post-stroke.
- Minocycline compared to placebo, when administered between 3 to 48 hours after onset of acute ischemic stroke improves functional outcome as assessed by the Barthel Index (BI) score on day 90 post-stroke.
- Minocycline, compared with placebo reduces 90 day risk of recurrent stroke, MI or death when administered between 3 to 48 hours after acute ischemic stroke onset.
A positive result will have a significant impact in the management of acute ischemic stroke and pave the way for future studies aimed at finding the optimal dose and formulation of minocycline for treating acute ischemic stroke.
|Acute Stroke||Drug: Minocycline (Borymycin) Drug: Matched placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Neuroprotection With Minocycline Therapy for Acute Stroke Recovery Trial, A Double-Blind, Randomized, Placebo-controlled, Multi-center Study|
- Reduction of neurologic deficits and improvement of functional outcome on day 90 post-stroke [ Time Frame: 3 months ]
- Reduction of 90 day risk of recurrent ischemic stroke, myocardial infarction and death [ Time Frame: 3 months ]
|Study Start Date:||July 2009|
|Study Completion Date:||November 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: matching placebo pill
Drug: Matched placebo
matched placebo (cornstarch) once a day for 5 days
Other Name: Placebo - cornstarch
Active Comparator: Oral minocycline
Drug: Minocycline (Borymycin)
oral dose, 200 mg once a day for 5 days
Other Name: Borymycin
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930020
|National Neuroscience Institute - Tan Tock Seng hospital|
|Singapore, Singapore, 308433|
|Principal Investigator:||Rajinder Singh, Doctor||National Neuroscience Institute - Tan Tock Seng campus and Changi hospital|