Multiple Sclerosis, Secondary ProgressivePhase 3MAESTRO-03NCT00468611
Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis
A Phase 3 study testing MBP8298 in people with Multiple Sclerosis, Secondary Progressive, run by BioMS Technology Corp..
Trial summary
This study will assess the efficacy and safety of MBP8298 compared to placebo in subjects with Secondary Progressive Multiple Sclerosis (SPMS) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Secondary Progressive
- What is being tested?
- MBP8298
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 510 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Sep 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this 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
This study will assess the efficacy and safety of MBP8298 compared to placebo in subjects with Secondary Progressive Multiple Sclerosis (SPMS)
- Being tested
- MBP8298
- Keywords
- Secondary Progressive Multiple Sclerosis, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBP8298Drug
500mg MBP8298 IV every six months for a period of two years
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: MBP8298 |
| 2 | Placebo comparator | Not described Receives: Drug: MBP8298 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression of disease in subjects with SPMS as measured by the EDSS after 24 months of treatment
Measured: 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
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2007 (estimated)
- Study startJun 2007
- Primary completionJul 2009
- Study completionSep 2009 (estimated)
Why it stopped: Negative efficacy results of the MAESTRO-01 study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Secondary ProgressiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMS Technology Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clyde E Markowitz, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468611
- Sponsor's protocol ID
- MBP8298-SP-03
- Acronym
- MAESTRO-03
- Status last verified
- Aug 2009
- First submitted
- 1 May 2007
- Last updated
- 13 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00468611
- Acronym / sponsor ID
- MAESTRO-03 / MBP8298-SP-03
- Keywords
- Secondary Progressive Multiple Sclerosis, Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Negative efficacy results of the MAESTRO-01 study
- Enrolment
- 510 participants (actual)
- Lead sponsor
- BioMS Technology Corp.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (estimated)
- First posted
- 3 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy and safety of MBP8298 compared to placebo in subjects with Secondary Progressive Multiple Sclerosis (SPMS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MBP8298 |
| 2 | Placebo comparator | Drug: MBP8298 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBP8298500mg MBP8298 IV every six months for a period of two years | Drug | 1, 2 |
Primary outcome
Time to progression of disease in subjects with SPMS as measured by the EDSS after 24 months of treatment
Time frame: 24 Months
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Negative efficacy results of the MAESTRO-01 study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clyde E Markowitz, MD principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MBP8298 in people with Multiple Sclerosis, Secondary Progressive, run by BioMS Technology Corp..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Negative efficacy results of the MAESTRO-01 study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression of disease in subjects with SPMS as measured by the EDSS after 24 months of treatment (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2009; AzTrials last refreshed its copy on 8 Nov 2026.