Clinically Isolated Syndromes Clinical Trial
Official title:
A Phase III Double-blind, Randomized, Placebo-controlled Trial of Minocycline in Clinically Isolated Syndromes (CIS) and Early Single Relapse Multiple Sclerosis (MS)
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.
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