NCT00468611

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
510

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2007

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2007

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

August 13, 2009

Status Verified

August 1, 2009

Enrollment Period

2.1 years

First QC Date

May 1, 2007

Last Update Submit

August 12, 2009

Conditions

Multiple Sclerosis, Secondary Progressive

Keywords

Secondary Progressive Multiple SclerosisMultiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Time to progression of disease in subjects with SPMS as measured by the EDSS after 24 months of treatment

    24 Months

Secondary Outcomes (1)

  • 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

    24 Months

Study Arms (2)

1

EXPERIMENTAL
Drug: MBP8298

2

PLACEBO COMPARATOR
Drug: MBP8298

Interventions

MBP8298DRUG

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

12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis, Chronic ProgressiveMultiple Sclerosis

Interventions

MBP-8298

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clyde E Markowitz, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 1, 2007

First Posted

May 3, 2007

Study Start

June 1, 2007

Primary Completion

July 1, 2009

Study Completion

September 1, 2009

Last Updated

August 13, 2009

Record last verified: 2009-08