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Efficacy and Safety of MBP829...

Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis

Last Updated: 2009-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-09-30

Brief Summary

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This study will assess the efficacy and safety of MBP8298 compared to placebo in subjects with Secondary Progressive Multiple Sclerosis (SPMS)

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Detailed Description

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Conditions

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Multiple Sclerosis, Secondary Progressive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

MBP8298

Intervention Type DRUG

500mg MBP8298 IV every six months for a period of two years

2

Group Type PLACEBO_COMPARATOR

MBP8298

Intervention Type DRUG

500mg MBP8298 IV every six months for a period of two years

Interventions

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MBP8298

500mg MBP8298 IV every six months for a period of two years

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male of female subjects, 18-65 years of age with a diagnosis of SPMS
* HLA DR2 and/or DR4 positive
* Absence of a relapse in the 3 months prior to baseline
* EDSS of 3.0 - 6.5

Exclusion Criteria

* Therapy with Beta-interferon, glatiramer acetate within 3 months or mitoxantrone, cyclophosphamide, methotrexate, azathioprine or any immune modulating or immunosuppressive drugs within 6 months of baseline
* Treatment with Tysabri within 2 years of baseline
* Females who are breast feeding, pregnant (pregnancy test at baseline) or not using a medically approved method of contraception regularly

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers