Combination Therapy of Betaseron-Prograf in Multiple Sclerosis
Status:
Unknown status
Trial end date:
2006-09-01
Target enrollment:
Participant gender:
Summary
The purpose of the study is to evaluate the safety and tolerability of a combination of
interferon beta 1-b (Betaseron®) and tacrolimus (Prograf®) in patients suffering from
multiple sclerosis (MS) who have failed treatment with currently approved drugs for MS
Prograf is an immunosuppressant that weakens the immune reactions responsible to protect the
organism against infections. It is currently available on the market for patients who have
received an organ transplant, to prevent rejection. Because of its effect on the immune
system, theoretically, Prograf should exert a significant effect in MS. It has been tried in
a small number of MS patients at a lower dose than the one used in organ transplant, however
the results of the study did not allow to draw definite conclusions on its safety and
efficacy in MS.
Betaseron is approved in Canada for the reduction of the frequency of relapses in patients
with relapsing-remitting MS and for the slowing of progression and reduction of the frequency
of relapses in patients with secondary-progressive MS. The combination of Betaseron and
Prograf may result in an additive effect or an increase in the actions of the drugs. However,
the combination of the two drugs has never been studied.
The aim of this study is to see how well the combination of Betaseron and Prograf is
tolerated by patients with MS. The side effects of the treatment, if any, will be followed.
In addition, the efficacy of the combination will be evaluated.
Phase:
Phase 2
Details
Lead Sponsor:
Clinique de sclérose en plaques et neuromusculaire de l'Outaouais