Secondary Progressive Multiple SclerosisPhase 2/3MAESTRO-02NCT00870155
A Study for Patients With Multiple Sclerosis
A Phase 2/3 study testing dirucotide in people with Secondary Progressive Multiple Sclerosis, run by Eli Lilly and Company at 10 sites in 10 countries.
Trial summary
To obtain additional safety data in subjects who have previously completed the MBP8298-01 study "A Double Blind Placebo Controlled Multi-Centre to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Multiple Sclerosis" Dirucotide is generic name for MBP8298. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Secondary Progressive Multiple Sclerosis
- What is being tested?
- dirucotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 546 participants
- Where
- 10 sitesin 10 countries
- Study dates
- Feb 2007to Sep 2009
- Phase
- Phase 2/3
- 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
- Subjects participating in this study must have completed treatment and all required evaluations in the previous MBP8298-01 study "A Double Blind Placebo Controlled Multi-Centre Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Progressive Multiple Sclerosis",
- Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial in accordance with regulatory requirements,
- In the Investigator's opinion, subjects must be reliable, compliant and agree to cooperate with all trial evaluations.
Who cannot join
- Use of any concomitant disease modifying therapy for Multiple Sclerosis e.g. ß-interferon, glatiramer acetate or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g. IVIG) or immunosuppressive drugs including recombinant or non-recombinant cytokines.
- Any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements.
- Any other condition that, in the Investigator's opinion, makes the subject unsuitable for participation in the study.
- Females who are breast feeding, pregnant or not using a medically approved method of contraception regularly.
Trial locations and contacts
10 sites in 10 countries.
10 sites in 10 countries
Germany1 site
Heinrich Heine Universitaets
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: An Open Label Follow-On Study to Assess the Ongoing Safety of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis
To obtain additional safety data in subjects who have previously completed the MBP8298-01 study "A Double Blind Placebo Controlled Multi-Centre to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Multiple Sclerosis" Dirucotide is generic name for MBP8298.
- Conditions
- Secondary Progressive Multiple Sclerosis
- Being tested
- dirucotide
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dirucotideDrug
Also called MBP8298, LY2820671
500mg, intravenous, every 6mos until regulatory approval, denial or sponsor termination
| Study group | Role | What they receive |
|---|---|---|
| Dirucotide | Experimental | Not described Receives: Drug: dirucotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess clinically significant effects of MBP8298 synthetic peptide in all subjects by collecting adverse event, ECG, laboratory, and physical exam outcomes
Measured: every 6 mos
Secondary outcomes (7)
Degree of change in Kurtzke Expended Disability Status (EDSS)
Measured: every 6mos
Brain atrophy by MRI
Measured: every 6mos
Activity analysis of T2 and Gadolinium enhancing lesions
Measured: every 6mos
Lesion burden
Measured: every 6mos
Degree of change in MS Functional Composite Index (MSFC)
Measured: every 6mos
Relapse rates
Measured: every 6mos
Quality of life as measured by Short Form 36 (SF-36) or MSQoL54
Measured: every 6mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startFeb 2007
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Negative efficacy results of the MAESTRO-01 trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Progressive Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 546 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioMS Technology Corp.
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870155
- Sponsor's protocol ID
- 12789
- Other IDs
- I3E-BM-MSAC, 2007-001480-30, MBP8298-SP-02
- Acronym
- MAESTRO-02
- Status last verified
- Sep 2010
- First submitted
- 26 Mar 2009
- Last updated
- 9 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Follow-On Study to Assess the Ongoing Safety of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00870155
- Acronym / sponsor ID
- MAESTRO-02 / 12789
- Conditions
- Secondary Progressive Multiple Sclerosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Negative efficacy results of the MAESTRO-01 trial
- Enrolment
- 546 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- BioMS Technology Corp.
- Study start
- Feb 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 27 Mar 2009 (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.
To obtain additional safety data in subjects who have previously completed the MBP8298-01 study "A Double Blind Placebo Controlled Multi-Centre to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Multiple Sclerosis" Dirucotide is generic name for MBP8298.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dirucotide | Experimental | Drug: dirucotide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects participating in this study must have completed treatment and all required evaluations in the previous MBP8298-01 study "A Double Blind Placebo Controlled Multi-Centre Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Progressive Multiple Sclerosis",
- Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial in accordance with regulatory requirements,
- In the Investigator's opinion, subjects must be reliable, compliant and agree to cooperate with all trial evaluations.
Key exclusion criteria (4 listed)
- Use of any concomitant disease modifying therapy for Multiple Sclerosis e.g. ß-interferon, glatiramer acetate or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g. IVIG) or immunosuppressive drugs including recombinant or non-recombinant cytokines.
- Any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements.
- Any other condition that, in the Investigator's opinion, makes the subject unsuitable for participation in the study.
- Females who are breast feeding, pregnant or not using a medically approved method of contraception regularly.
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 |
|---|---|---|
| dirucotideAlso: MBP8298, LY2820671500mg, intravenous, every 6mos until regulatory approval, denial or sponsor termination | Drug | Dirucotide |
Primary outcome
To assess clinically significant effects of MBP8298 synthetic peptide in all subjects by collecting adverse event, ECG, laboratory, and physical exam outcomes
Time frame: every 6 mos
7 secondary outcomes
Degree of change in Kurtzke Expended Disability Status (EDSS)
Time frame: every 6mos
Brain atrophy by MRI
Time frame: every 6mos
Activity analysis of T2 and Gadolinium enhancing lesions
Time frame: every 6mos
Lesion burden
Time frame: every 6mos
Degree of change in MS Functional Composite Index (MSFC)
Time frame: every 6mos
Relapse rates
Time frame: every 6mos
Quality of life as measured by Short Form 36 (SF-36) or MSQoL54
Time frame: every 6mos
Results and safety
The study was stopped early (reason given: Negative efficacy results of the MAESTRO-01 trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2010.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
10 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing dirucotide in people with Secondary Progressive Multiple Sclerosis, run by Eli Lilly and Company at 10 sites in 10 countries.
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 3 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 9 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada, Denmark, Estonia, Finland, Germany and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 trial). 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?
To assess clinically significant effects of MBP8298 synthetic peptide in all subjects by collecting adverse event, ECG, laboratory, and physical exam outcomes (time frame: every 6 mos). 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 9 Sep 2010; AzTrials last refreshed its copy on 27 Oct 2026.