Combination Therapy of Betaseron-Prograf in Multiple Sclerosis
NCT ID: NCT00298662
Last Updated: 2006-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2003-02-28
2006-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Interferon beta-1b and Tacrolimus
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
55 Years
ALL
No
Sponsors
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Clinique de sclérose en plaques et neuromusculaire de l'Outaouais
OTHER
Principal Investigators
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François Jacques
Role: PRINCIPAL_INVESTIGATOR
Multiple Sclerosis Clinic - Hull Hospital
Locations
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Clinique de sclérose en plaques et neuromusculaire
Gatineau, Quebec, Canada
Countries
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Other Identifiers
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137-020826
Identifier Type: -
Identifier Source: org_study_id