The aim of the trial is to demonstrate that 100 mg of oral minocycline twice daily reduces the conversion of CIS to McDonald Criteria MS (McDMS) by an absolute 25% as compared to placebo, over a 6 month follow-up period (primary outcome). A key secondary outcome is to confirm that this early treatment benefit is maintained at two years.
* Minocycline 100 mg bid orally compared to identical placebo * Clinically Isolated Syndrome (CIS): Patients with a first clinical demyelinating event suggestive of multiple sclerosis (At baseline participants may meet 2010 McDonald diagnostic criteria for MS, but not 2005 criteria) * Men and women, aged 18-60y, first event within the previous 180 days; brain magnetic resonance imaging (MRI) with at least two brain T2 lesions which are at least 3 mm in diameter, and at least one of which is ovoid or periventricular or infratentorial. * Up to 24 months of study drug (Up to 12 months of study drug for patients recruited after December 31, 2012) * Patients will be discontinued from the study when they convert to McDMS based on the 2005 McDonald definition. * 12 Canadian MS Clinics * A total of 154 patients will be randomized. Because 30% of screened patients with CIS who are clinically eligible are not expected to meet the MRI criteria for inclusion, up to 280 patients will be screened.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
142
100 mg twice daily to be taken for up to 2 years
placebo twice daily for 2 years
University of Calgary, Calgary Health Region
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Fraser Health Multiple Sclerosis Clinic
Burnaby, British Columbia, Canada
To demonstrate that 100 mg of oral minocycline twice daily reduces the conversion of CIS to McDonald Criteria MS (McDMS) by an absolute 25% as compared to placebo, over a 6 month follow-up period.
Time frame: 6 Months
To confirm that this early treatment benefit is maintained at two years.
Time frame: 2 years
Change in T2 lesion volume
Time frame: 6 months and 24 months
Cumulative number of enhancing T1 lesions
Time frame: 6 months and 24 months
cumulative combined unique lesions (new enhancing T1-weighted lesions plus new and enlarging T2 lesions, without lesion double counting)
Time frame: 6 months and 24 months
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UBC Hospital
Vancouver, British Columbia, Canada
MS Research Unit, Health Sciences Centre
Winnipeg, Manitoba, Canada
Dalhousie MS Research Unit
Halifax, Nova Scotia, Canada
MS Clinic, London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital, Multiple Sclerosis Research Clinic
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Clinique Neuro Rive-Sud
Greenfield Park, Quebec, Canada
...and 2 more locations