Lack of efficacy

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.

Primary outcome measure:

The cumulative number of new GdE T1 lesions developing while on treatment.

Secondary outcome measures:

• MRI:

  • Cumulative number of total GdE T1 lesions developing while on treatment
  • Cumulative number of new T2 lesions
  • Patients free of GdE (T1-weighted) lesions at week 24
  • Change in volume of GdE T1
  • Brain atrophy
  • Cumulative number of new T1 hypointense lesions (black holes)

• 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

1. Diagnosis of relapsing MS according to the revised 2005 McDonald criteria.

2. 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):

   1. Gd-enhancing on any scan obtained in the last year, or
   2. new T2 lesions between two scans both obtained within the last year.
   3. A minimum total of 9 T2 lesions reported on a recent MRI obtained within 1 month prior to the screening visit.

3. Baseline EDSS score 0 - 5.5.

4. 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:

1. Has experienced an MS relapse or received systemic corticosteroids or adrenocorticotropic hormone (ACTH) in the previous 1 month.

2. Has a secondary progressive (SPMS), progressive relapsing (PRMS), or primary progressive MS (PPMS).

3. Has received any of the following agents to treat MS (approved or unapproved):

   • Within the previous 3 months: interferon beta, glatiramer acetate, intravenous immunoglobulin or plasmapheresis.
   • Within the previous 12 months: natalizumab, daclizumab, cytapheresis, azathioprine, cladribine, cyclophosphamide, methotrexate, mitoxantrone, mycophenolate, pixantrone, sirolimus, tacrolimus, or other agents typically used to prevent transplant rejection or as cancer chemotherapy, excluding hormonal treatments.
   • Ever having received: stem cell or bone marrow transplant, total lymphoid irradiation, vaccine therapy for MS, or monoclonal antibodies whose effects may be longer than 1 year (such as alemtuzumab or rituximab).
   • Within the previous 3 months: any other agents given for the non-symptomatic treatment of MS which are not included above, including over-the-counter, herbal and nutritional supplements. However, if the agent is being taken primarily to treat another medical condition, then it is allowed as long as the dose is unchanged within the previous 3 months and is unlikely to change before week

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):
• Gd-enhancing on any scan obtained in the last year, or
• new T2 lesions between two scans both obtained within the last year
• A minimum total of 9 T2 lesions reported on a recent MRI obtained within 1 month prior to the screening visit
• 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):
• Within the previous 3 months: interferon beta, glatiramer acetate, intravenous immunoglobulin or plasmapheresis
• Within the previous 12 months: natalizumab, daclizumab, cytapheresis, azathioprine, cladribine, cyclophosphamide, methotrexate, mitoxantrone, mycophenolate, pixantrone, sirolimus, tacrolimus, or other agents typically used to prevent transplant rejection or as cancer chemotherapy, excluding hormonal treatments
• Ever having received: stem cell or bone marrow transplant, total lymphoid irradiation, vaccine therapy for MS, or monoclonal antibodies whose effects may be longer than 1 year (such as alemtuzumab or rituximab)
• Within the previous 3 months: any other agents given for the non-symptomatic treatment of MS which are not included above, including over-the-counter, herbal and nutritional supplements. However, if the agent is being taken primarily to treat another medical condition, then it is allowed as long as the dose is unchanged within the previous 3 months and is unlikely to change before week 24.