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To determine the efficacy and safety of an oral drug (BGC20-0134) in patients with relapsing remitting multiple sclerosis. Specifically, the cumulative number of new gadolinium enhancing lesions after 24 weeks of treatment with BGC20-0134.
Full description
Primary outcome measure:
The cumulative number of new GdE T1 lesions developing while on treatment.
Secondary outcome measures:
MRI:
Disease burden, T1 and T2 lesion activity at week 48.
Number of clinical relapses from baseline to the end of treatment. • Change on the Expanded Disability Status Scale (EDSS)
Number of patients requiring methylprednisolone treatment for a relapse.
Serum levels of pro- and anti-inflammatory cytokines.
Quality of life (MSQOL-54)
Eligibility Criteria
MS-Related inclusion criteria
Diagnosis of relapsing MS according to the revised 2005 McDonald criteria.
Has shown disease activity defined by 1 or more MS attack within the last year which has been documented in prior medical notes and or the presence of active lesions on historical scans being either (based on radiology report or investigator review of MRI):
Baseline EDSS score 0 - 5.5.
Has refused to be treated with approved disease modifying therapies available for MS, for any reason and once the investigator has fully informed the patient about the related benefits and potential adverse events associated with such treatments. Also, patients for whom such treatments have proved to be intolerable.
Exclusion Criteria:
Has experienced an MS relapse or received systemic corticosteroids or adrenocorticotropic hormone (ACTH) in the previous 1 month.
Has a secondary progressive (SPMS), progressive relapsing (PRMS), or primary progressive MS (PPMS).
Has received any of the following agents to treat MS (approved or unapproved):
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Interventional model
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173 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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