Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatment interferon beta-1b and tacrolimus
Phase phase 2
Sponsor Clinique de sclérose en plaques et neuromusculaire de l'Outaouais
Start date February 2003
End date September 2006
Trial size 30 participants
Trial identifier NCT00298662, 137-020826

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
safety and tolerability
time frame:
relapse rate
time frame:
number of T2 godolinium enhencing lesions on MRI
time frame:
expanded disease severity score (EDSS)
time frame:
multiple sclerosis functional composite(MSFC)
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - relapsing-remitting or secondary-progressive multiple sclerosis - patients who have failed treatment with approved immunomodulator drugs (having experienced same or higher annual relapse rate or having experinced progression on the EDSS scale) - Expanded Disability Status Scale (EDSS) score less than 7.0 Exclusion Criteria: - any of the following conditions: diabetes mellitus, uncontrolled hypertension, active infection or viral diseases

Additional Information

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
Principal investigator François Jacques
Trial information was received from ClinicalTrials.gov and was last updated in March 2006.
Information provided to ClinicalTrials.gov by Clinique de sclérose en plaques et neuromusculaire de l'Outaouais.