Secondary Progressive Multiple SclerosisPhase 2/3MAESTRO-01NCT00869726
A Study for Patients With Secondary Progressive 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
The purpose of this study is to determine whether MBP8298 is effective and safe in the treatment secondary progressive 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?
- Yes, some participants may receive a placebo
- How many people
- 596 participants
- Where
- 10 sitesin 10 countries
- Study dates
- Dec 2004to May 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
- Documented history of SPMS
- Absence of relapse in the 3mos prior to baseline
- EDSS of 3.5 - 6.5
- Pyramidal or Cerebellar FSS greater than or equal to 3
- A cohort of 100 HLA DR2/4 negative patients is required. Once enrollment to this cohort is complete, all further patients are required to be HLA DR2/4 positive.
- Informed consent
- Subject reliability and compliance
Who cannot join
- Diagnosis of Primary Progressive MS
- Subjects have previously received MBP8298
- Recent history of malignancy, with the exclusion on basal cell carcinoma.
- Steroid therapy within 30 days prior to first study specific procedure or any other treatment known to be used for putative or experimental MS treatment
- Therapy with beta-interferon, glatiramer acetate within 3 mos or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating or immunosuppressive drugs including recombinant or non-recombinant cytokines or plasma exchange within 6 mos prior to performance of the first study-specific test, with the exception of corticosteroids or ACTH for relapse treatment.
- Initiation or discontinuation of therapy with 4-AP or 3,4-DAP at any time during the study period.
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- History of anaphylactic/anaphlactoid reactions to glatiramer acetate
- Abnormal lab values at the Screening Visit deemed by the Investigator to be clinically significant
- Known allergy to Gadolinium-DTPA
- Treatment at any time with Cladribine, total lymphoid irradiation, monoclonal antibody treatment
- Treatment at any time wtih an altered peptide ligand
- Any conditions that could interfere with the performance of study specific procedures e.g.MRI
- Previous randomization to this study
- Known positivity for HIV, Hepatitis B, or Hepatitis C
- Participation in any other non-MS clinical trial within 30 days prior to performance of the first study specific test or any investigational therapy in the past 6 mos.
- Females who are breast feeding, pregnant or not using a medically approved method of contraception regularly
- Known or suspected current or past alcohol or drug abuse (within the last year)
- 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
Trial locations and contacts
10 sites in 10 countries.
10 sites in 10 countries
About this study
Official title: A Double-Blind, Placebo Controlled Multicentre Study To Evaluate The Efficacy And Safety Of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis
The purpose of this study is to determine whether MBP8298 is effective and safe in the treatment secondary progressive multiple sclerosis.
Dirucotide is generic name for MBP8298.
- Conditions
- Secondary Progressive Multiple Sclerosis
- Being tested
- dirucotide, Placebo
- 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, dosed once every six months for 18 months
PlaceboDrug
intravenous, once every six months for 18 months
| Study group | Role | What they receive |
|---|---|---|
| Dirucotide | Experimental | Not described Receives: Drug: dirucotide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS).
Measured: baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos
Secondary outcomes (7)
degree of change in EDSS
Measured: baseline, 24mos
Brain Atrophy by MRI
Measured: baseline, 12mos, 24mos
Activity analysis of T2 and Gadolinium enhancing lesions
Measured: 12mos and 24mos
Lesion burden
Measured: 12mos and 24mos
Degree of change in MS Functional Composite Index (MSFC)
Measured: baseline, 3mos, 6mos, 9mos, 12mos, 15mos, 18mos, 21mos, 24mos
Relapse rates
Measured: baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos
Quality of life as measured by Short Form 36 (SF-36) or MSQoL54
Measured: baseline, 6mos, 12mos, 18mos, 24mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startDec 2004
- Primary completionMay 2009
- Study completionMay 2009
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 596 participants (actual)
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 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
- NCT00869726
- Sponsor's protocol ID
- 12788
- Other IDs
- I3E-BM-MSAB, MBP8298-01
- Acronym
- MAESTRO-01
- Status last verified
- May 2010
- First submitted
- 24 Mar 2009
- Last updated
- 2 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo Controlled Multicentre Study To Evaluate The Efficacy And Safety Of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00869726
- Acronym / sponsor ID
- MAESTRO-01 / 12788
- Conditions
- Secondary Progressive Multiple Sclerosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- BioMS Technology Corp.
- Study start
- Dec 2004
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 26 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.
The purpose of this study is to determine whether MBP8298 is effective and safe in the treatment secondary progressive multiple sclerosis.
Dirucotide is generic name for MBP8298.
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 |
|---|---|---|
| Dirucotide | Experimental | Drug: dirucotide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Documented history of SPMS
- Absence of relapse in the 3mos prior to baseline
- EDSS of 3.5 - 6.5
- Pyramidal or Cerebellar FSS greater than or equal to 3
- A cohort of 100 HLA DR2/4 negative patients is required. Once enrollment to this cohort is complete, all further patients are required to be HLA DR2/4 positive.
Key exclusion criteria (19 listed)
- Diagnosis of Primary Progressive MS
- Subjects have previously received MBP8298
- Recent history of malignancy, with the exclusion on basal cell carcinoma.
- Steroid therapy within 30 days prior to first study specific procedure or any other treatment known to be used for putative or experimental MS treatment
- Therapy with beta-interferon, glatiramer acetate within 3 mos or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating or immunosuppressive drugs including recombinant or non-recombinant cytokines or plasma exchange within 6 mos prior to performance of the first study-specific test, with the exception of corticosteroids or ACTH for relapse treatment.
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, dosed once every six months for 18 months | Drug | Dirucotide |
| Placebointravenous, once every six months for 18 months | Drug | Placebo |
Primary outcome
Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS).
Time frame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos
7 secondary outcomes
degree of change in EDSS
Time frame: baseline, 24mos
Brain Atrophy by MRI
Time frame: baseline, 12mos, 24mos
Activity analysis of T2 and Gadolinium enhancing lesions
Time frame: 12mos and 24mos
Lesion burden
Time frame: 12mos and 24mos
Degree of change in MS Functional Composite Index (MSFC)
Time frame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos, 18mos, 21mos, 24mos
Relapse rates
Time frame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos
Quality of life as measured by Short Form 36 (SF-36) or MSQoL54
Time frame: baseline, 6mos, 12mos, 18mos, 24mos
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 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 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 7 inclusion and 19 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: finished, as of the sponsor's last update on 2 Jun 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. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS). (time frame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos). 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 2 Jun 2010.