Combination Therapy of Betaseron-Prograf in Multiple Sclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Clinique de sclérose en plaques et neuromusculaire de l'Outaouais.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Clinique de sclérose en plaques et neuromusculaire de l'Outaouais
ClinicalTrials.gov Identifier:
NCT00298662
First received: March 2, 2006
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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
Multiple Sclerosis
Drug: Interferon beta-1b and Tacrolimus
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Clinique de sclérose en plaques et neuromusculaire de l'Outaouais:

Primary Outcome Measures:
  • safety and tolerability
  • relapse rate
  • number of T2 godolinium enhencing lesions on MRI
  • expanded disease severity score (EDSS)
  • multiple sclerosis functional composite(MSFC)

Estimated Enrollment: 30
Study Start Date: February 2003
Estimated Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298662

Locations
Canada, Quebec
Clinique de sclérose en plaques et neuromusculaire
Gatineau, Quebec, Canada, J8Y 1W7
Sponsors and Collaborators
Clinique de sclérose en plaques et neuromusculaire de l'Outaouais
Investigators
Principal Investigator: François Jacques Multiple Sclerosis Clinic - Hull Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00298662     History of Changes
Other Study ID Numbers: 137-020826
Study First Received: March 2, 2006
Last Updated: March 2, 2006
Health Authority: Canada: Health Canada

Keywords provided by Clinique de sclérose en plaques et neuromusculaire de l'Outaouais:
Multiple Sclerosis
Betaseron-Prograf
patients of Multiple Sclerosis
Secondary Progressive type
Relapsing-Remitting type

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Tacrolimus
Interferon beta-1b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Immunosuppressive Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 23, 2014