Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis - Full Text View

Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis (MAESTRO-03)

This study is ongoing, but not recruiting participants.

First Received: May 1, 2007 Last Updated: April 6, 2009 History of Changes

Sponsored by:	BioMS Technology Corp.
Information provided by:	BioMS Technology Corp.
ClinicalTrials.gov Identifier:	NCT00468611

Purpose

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

Condition	Intervention	Phase
Multiple Sclerosis, Secondary Progressive	Drug: MBP8298	Phase III

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis

Further study details as provided by BioMS Technology Corp.:

Primary Outcome Measures:

Time to progression of disease in subjects with SPMS as measured by the EDSS after 24 months of treatment [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the safety of MBP8298, degree of change in the EDSS scores, effect of MBP8298 on MRI parameters, difference in relapse rates, effect on MSFC, subject's quality of life (MSQoL54) and fatigue (MFIS) after 24 months of treatment [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	510
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: MBP8298 500mg MBP8298 IV every six months for a period of two years
2: Placebo Comparator	Drug: MBP8298 500mg MBP8298 IV every six months for a period of two years

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468611

Show 61 Study Locations

Sponsors and Collaborators

BioMS Technology Corp.

Investigators

Principal Investigator:

Clyde E Markowitz, MD

University of Pennsylvania

More Information

No publications provided

Study ID Numbers:	MBP8298-SP-03
Study First Received:	May 1, 2007
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00468611 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by BioMS Technology Corp.:

Secondary Progressive Multiple Sclerosis
Multiple Sclerosis

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Neoplasm Metastasis

Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System
Multiple Sclerosis, Chronic Progressive

Additional relevant MeSH terms:

Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Sclerosis
Multiple Sclerosis, Chronic Progressive
Neoplastic Processes

Neoplasms
Multiple Sclerosis
Pathologic Processes
Neoplasm Metastasis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 06, 2009