Acute Stroke Clinical Trial
— NeuMASTOfficial title:
Neuroprotection With Minocycline Therapy for Acute Stroke Recovery Trial, A Double-Blind, Randomized, Placebo-controlled, Multi-center Study
Verified date | May 2013 |
Source | Singhealth Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | Singapore: Health Sciences Authority |
Study type | Interventional |
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.
Secondary Hypotheses:
1. 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.
2. 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.
3. 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.
Status | Terminated |
Enrollment | 139 |
Est. completion date | November 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Singapore citizens or permanent residents - Age range between 21 to 80 years - NIHSS equal or more than 5 but less than 22 at time of admission - Clinical diagnosis of acute ischemic stroke according to WHO criteria - Onset of stroke between 3 to 48 hours prior to start of treatment - Must have a working telephone line Exclusion Criteria: - Long term residents of Institutions and Nursing homes - Patients with significant baseline cognitive dysfunction - Patients with hemorrhagic stroke - Pre-stroke MRS more than 1 - Evidence of other disease of the CNS (i.e., brain tumor, CNS infections) - Known allergic response to tetracycline - Acute or Chronic renal failure - Hepatitis or liver disease - Pre-existing infectious disease requiring antibiotics - Receipts of IV rTPA - Participation in another clinical trial in the preceding 3 months - Unable or unwilling to provide inform consent - Unwilling to return for frequent clinic visits - Geographic or social factors making the study participation impractical |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Singapore | National Neuroscience Institute - Tan Tock Seng hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singhealth Foundation | Changi General Hospital, National Neuroscience Institute |
Singapore,
Lampl Y, Boaz M, Gilad R, Lorberboym M, Dabby R, Rapoport A, Anca-Hershkowitz M, Sadeh M. Minocycline treatment in acute stroke: an open-label, evaluator-blinded study. Neurology. 2007 Oct 2;69(14):1404-10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of neurologic deficits and improvement of functional outcome on day 90 post-stroke | 3 months | Yes | |
Secondary | Reduction of 90 day risk of recurrent ischemic stroke, myocardial infarction and death | 3 months | Yes |
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