Status:
TERMINATED
Neuroprotection With Minocycline Therapy for Acute Stroke Recovery Trial
Lead Sponsor:
Singhealth Foundation
Collaborating Sponsors:
National Neuroscience Institute
Changi General Hospital
Conditions:
Acute Stroke
Eligibility:
All Genders
21-80 years
Phase:
PHASE4
Brief Summary
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 i...
Detailed Description
A) Specific Primary Objective: 1\. To determine if minocycline, administered within 3 to 48 hours of acute ischemic stroke onset is superior to placebo in reducing neurological deficit and improving ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT00930020
Start Date
July 1 2009
End Date
November 1 2012
Last Update
June 3 2013
Active Locations (1)
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1
National Neuroscience Institute - Tan Tock Seng hospital
Singapore, Singapore, 308433