MBP 8298 for SPMS Phase III Trial in Canada

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MBP 8298 for SPMS Phase III Trial in Canada

Postby Chilcotin » Fri Mar 11, 2005 1:24 am

Clinical Trial Information for MBP8298

A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis
This is a two-year, randomized, double-blind, placebo-controlled, parallel-group trial in secondary progressive MS patients, comparing the time to confirmed worsening of disability as measured by EDSS (Expanded Disability Status Scale).

The trial is expected to enroll up to 553 patients. Patients will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the EDSS in the previously identified responder group, patients with immune response genes HLA-DR2 or HLA-DR4.

Inclusion Criteria:
In order to meet the regulatory requirements, a series of inclusion criteria has been identified for patients who would be safely and appropriately offered the opportunity to participate in the trial. Listed below are some (but not all) of the inclusion criteria requirements:

Age between 18 and 65 years old
Diagnosis of multiple sclerosis by a neurologist
Diagnosis of multiple sclerosis for at least three years
Clinical proof of progression of multiple sclerosis within the last 3 years
Having reached Expanded Disability Status Scale (EDSS) of 3.5 or more since diagnosis (moderate disability in one functional system; fully ambulatory)
Having an EDSS score between 3.5 and 6.5 (constant bilateral assistance required to walk 10m without resting, moderate disability in two functional systems)
EDSS Cerebellar Functional sub score of 3 or more or EDSS Pyramidal Functional sub score of 3 or more (indicating at least partial paralysis of one side of the body [hemiparesis] or partial paralysis of the lower limbs [paraparesis] or moderate tremor of the arms, leg or trunk)
Must not be allergic to Copaxone® or Gadolinium
Must not have ever taken Cladribine, Monoclonal antibodies
Must never have been treated with irradiation for their MS
Must not be infected with the AIDS virus, or with Hepatitis B or C
Must not be pregnant or breast-feeding
Must not have had cancer before (with the exception of Basal Cell Carcinoma)
Willing, able, reliable and agree to cooperate with all trial evaluations

Currently enrolling patients (see clinical trial sites below).

Patient Participation:
Due to the number of interested patients, referrals for participating in the trial must come from the patient’s neurologist or physician. Referrals must be submitted to the clinical trial sites (please keep updated on additional sites). Please note, not all participating clinical trial sites may be accepting new patients and the decision regarding the inclusion or exclusion of patients is the sole responsibility of the participating investigators. There is no guarantee for any patient of participation in the trial.

Clinical Trial Sites:
A limited number of sites are currently enrolling patients; additional sites across Canada and the UK will be added over the next several months. Please keep updated on additional clinical trial sites closer to your geographical area at www.biomsmedical.com.

St. Michael's Hospital - MS Research
Toronto, ON
Study Coordinator: 416-864-5834

Health Sciences Foundation, University of Manitoba
Winnipeg, MB

Foothills Medical Centre - MS Clinic
Calgary, AB
Study Coordinator: 403-944-4244

Vancouver Coastal Health Authority of British Columbia - MS Clinic
Vancouver, BC
Study Coordinator: 604-822-1756

The Ottawa Hospital - General Campus, Division of Neurology
Ottawa, ON

University of Alberta Hospital, Northern Alberta Clinical Trials and Research Centre
Edmonton, AB
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