Efficacy and Safety of MBP8298 in Subjects With Secondary... | NCT00468611

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

NCT00468611

Sponsor

BioMS Technology Corp.

Status

Terminated

Last Update Posted

Aug 13, 2009Estimated

Enrollment

510Actual

Phase

Phase 3

Conditions

Multiple Sclerosis, Secondary Progressive

Interventions

MBP8298

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Negative efficacy results of the MAESTRO-01 study

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Jul 2009Actual

Completion Date

Sep 2009Estimated

First Submitted Date

May 1, 2007

First Submission Date that Met QC Criteria

May 1, 2007

First Posted Date

May 3, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2009

Last Update Posted Date

Aug 13, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

510Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: MBP8298
2	Placebo Comparator		Drug: MBP8298

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MBP8298	Drug	500mg MBP8298 IV every six months for a period of two years	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to progression of disease in subjects with SPMS as measured by the EDSS after 24 months of treatment		24 Months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clyde E Markowitz, MD	University of Pennsylvania	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020528	Multiple Sclerosis, Chronic Progressive
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C526227	MBP-8298

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided