Neuroprotection With Minocycline Therapy for Acute Stroke Recovery Trial (NeuMAST)

This study has been terminated.
(interim analysis shows futility)
Sponsor:
Collaborators:
National Neuroscience Institute
Changi General Hospital
Information provided by (Responsible Party):
Dr. Rajinder Singh, Singhealth Foundation
ClinicalTrials.gov Identifier:
NCT00930020
First received: June 29, 2009
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Acute Stroke
Drug: Minocycline (Borymycin)
Drug: Matched placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Singhealth Foundation:

Primary Outcome Measures:
  • Reduction of neurologic deficits and improvement of functional outcome on day 90 post-stroke [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduction of 90 day risk of recurrent ischemic stroke, myocardial infarction and death [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 139
Study Start Date: July 2009
Study Completion Date: November 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: matching placebo pill
matching placebo
Drug: Matched placebo
matched placebo (cornstarch) once a day for 5 days
Other Name: Placebo - cornstarch
Active Comparator: Oral minocycline
Minocycline 200mg
Drug: Minocycline (Borymycin)
oral dose, 200 mg once a day for 5 days
Other Name: Borymycin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930020

Locations
Singapore
National Neuroscience Institute - Tan Tock Seng hospital
Singapore, Singapore, 308433
Sponsors and Collaborators
Singhealth Foundation
National Neuroscience Institute
Changi General Hospital
Investigators
Principal Investigator: Rajinder Singh, Doctor National Neuroscience Institute - Tan Tock Seng campus and Changi hospital
  More Information

Publications:
Responsible Party: Dr. Rajinder Singh, Dr, Singhealth Foundation
ClinicalTrials.gov Identifier: NCT00930020     History of Changes
Other Study ID Numbers: SHF/CTG016/2008
Study First Received: June 29, 2009
Last Updated: May 30, 2013
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Singhealth Foundation:
ischemic stroke recovery
minocycline
neuroprotection
acute stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014