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Sponsored by: |
Clinique de sclérose en plaques et neuromusculaire de l'Outaouais |
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Information provided by: | Clinique de sclérose en plaques et neuromusculaire de l'Outaouais |
ClinicalTrials.gov Identifier: | NCT00298662 |
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.
Condition | Intervention | Phase |
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Multiple Sclerosis |
Drug: Interferon beta-1b and Tacrolimus |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Safety and Tolerability Open-Label Study of Interferon Beta-1b in Combination With Tacrolimus in Patients Suffering From Multiple Sclerosis Who Have Failed Treatment With Approved Disease Modifying Agents |
Estimated Enrollment: | 30 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | September 2006 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Quebec | |
Clinique de sclérose en plaques et neuromusculaire | |
Gatineau, Quebec, Canada, J8Y 1W7 |
Principal Investigator: | François Jacques | Multiple Sclerosis Clinic - Hull Hospital |
Study ID Numbers: | 137-020826 |
Study First Received: | March 2, 2006 |
Last Updated: | March 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00298662 |
Health Authority: | Canada: Health Canada |
Multiple Sclerosis Betaseron-Prograf patients of Multiple Sclerosis Secondary Progressive type Relapsing-Remitting type |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Interferons Interferon beta-1b Interferon-beta |
Neoplasm Metastasis Demyelinating Autoimmune Diseases, CNS Demyelinating diseases Sclerosis Tacrolimus Autoimmune Diseases of the Nervous System |
Anti-Infective Agents Pathologic Processes Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Nervous System Diseases Adjuvants, Immunologic Immunosuppressive Agents Antiviral Agents Pharmacologic Actions |