Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00298662
Status:
UNKNOWN
Last Update Posted:
2006-03-03
First Post:
2006-03-02
Brief Title:
Combination Therapy of Betaseron-Prograf in Multiple Sclerosis
Sponsor:
Clinique de sclérose en plaques et neuromusculaire de lOutaouais
Organization:
Clinique de sclérose en plaques et neuromusculaire de lOutaouais
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None