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Q :
When will we get the results of the study out of Calgary that is looking into Minocycline for the treatment of MS?
A :
The testing of new medications in clinical trials proceeds at a very slow pace as one needs to be very careful and thoughtful of the trial results. Clinical trials also have to be conducted in a well-planned and rigorous manner so that results, either positive or negative, can be interpreted by the clinical community. As well, trials of a new medication normally evolve from a phase I (where the main outcome being measured is the safety profile of the drug), to phase II (to obtain preliminary evidence of efficacy and to obtain other information), to large phase III trials to obtain evidence of whether a given medication is efficacious or not. Only after favorable phase III results would a medication be considered for common use.
Clinical trials on minocycline in MS have been ongoing in Calgary but these are phase II trials of 10 patients using minocycline alone, or in a combination study of minocycline plus glatiramer acetate involving 44 patients. The phase II trial results of minocycline tested alone have recently been published in the medical journal Multiple Sclerosis. The results are promising but one would need to go to a phase III trial before minocycline would be considered for common clinical usage.
The MS Society of Canada through the Multiple Sclerosis Scientific Research Foundation has, in fact, just agreed to fund a phase III trial of minocycline in clinically isolated syndrome (CIS). CIS is a situation where a patient has one episode suggestive of possible MS, but has not yet been given the diagnosis of MS as one needs a second event to fall into the clinical diagnosis of MS. The $4 million trial of minocycline in CIS will involve over 200 patients across Canada and it will address whether minocycline can slow the conversion, or prevent entirely the conversion, of CIS to clinically definite MS. If so, this will be very useful for CIS patients but it will also generate impetus to address the utility of minocycline in the different forms of MS in phase III trials.
In summary, partial results are published and encouraging but they are not in the arena of recommended clinical usage as of yet.
9/14/2007
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