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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00298662 |
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Date of registration:
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02/03/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Combination Therapy of Betaseron-Prograf in Multiple Sclerosis
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Scientific title:
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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 |
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Date of first enrolment:
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February 2003 |
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Target sample size:
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30 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00298662 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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François Jacques |
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Address:
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Telephone:
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Email:
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Affiliation:
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Multiple Sclerosis Clinic - Hull Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Interferon beta-1b and Tacrolimus
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Primary Outcome(s)
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expanded disease severity score (EDSS)
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multiple sclerosis functional composite(MSFC)
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relapse rate
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safety and tolerability
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number of T2 godolinium enhencing lesions on MRI
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Secondary ID(s)
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137-020826
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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