Relapsing Remitting Multiple SclerosisPhase 2/3MINDSET01NCT00869986
A Study for Patients With Relapsing Remitting Multiple Sclerosis
A Phase 2/3 study testing dirucotide in people with Relapsing Remitting Multiple Sclerosis, run by Eli Lilly and Company at 6 sites in 6 countries.
Trial summary
The purpose of this study is to test if dirucotide is safe and effective in treating patients with relapsing remitting multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Relapsing Remitting 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
- 218 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Nov 2006to 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects, 18-50 years of age
- Relapsing-remitting multiple sclerosis (RRMS) according to "Diagnostic criteria for multiple sclerosis: 2005 revisions to the McDonald Criteria" (Annals of Neurology 58: 840-846)
- At least 2 years history of MS before trial entry
- Documented history of 2 or more exacerbations in the 2 years prior to trial entry
- Stable neurological status for at least 30 days before first study drug administration
- Have an EDSS from 0-5.5
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- If female, she must either
- be post-menopausal or surgically sterilized; or
- use a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and
- be neither pregnant nor breast-feeding
- Willingness and ability to comply with the protocol for the duration of the study
- In the Investigator's opinion, subjects must be reliable, compliant, and agree to cooperate with all trial evaluations
- Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements
Who cannot join
- Have Clinically Isolated Syndrome (CIS), Secondary Progressive MS (SPMS), Primary Progressive MS (PPMS)
- Any known malignancy, or history of malignancy, with the exclusion of basal cell carcinoma
- Have active, clinically significant liver, renal or bone marrow disease accompanied with significant laboratory abnormalities in the range of grade I or more as defined by Common Toxicity Criteria (CTC),
- Clinically significant ECG abnormalities at screening
- Have the presence of systemic disease that, in the opinion of the investigator, might interfere with subject safety, compliance or evaluation of the condition under study (e.g. insulin dependent diabetes, lyme disease, clinically significant cardiac, hepatic, or renal disease, Human Immunodeficiency Virus, or Human T-Cell Lymphotrophic Virus Type-1)
- Have current autoimmune disease, compromised immune function or infection
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- History of allergic reactions to glatiramer acetate
- 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 ß-interferon, glatiramer acetate, statins, copaxone or nonspecific phosphodiesterase inhibitors within 3 months prior to first study-specific test
- Therapy with mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g. IVIG) or immunosuppressive drugs including recombinant or non-recombinant cytokines or plasma exchange within 6 months prior to performance of the first study-specific test, with the exception of corticosteroids or ACTH for relapse treatment
- Treatment at any time with an altered peptide ligand, cladribine, total lymphoid irradiation, monoclonal anti-body treatment e.g. anti-CD4, anti-CD52, anti-VLA4, Anti-CD20,
- Any contraindications for MRI, e.g. pacemaker or known allergy to Gadolinium- DTPA
- Participation in any other trial of an investigational agent within 90 days prior to screening
- History of alcohol or drug abuse as specified by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) within the year before screening
- 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
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: A Double Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting Multiple Sclerosis
The purpose of this study is to test if dirucotide is safe and effective in treating patients with relapsing remitting multiple sclerosis.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- dirucotide, placebo
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
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 6 months for 15 months
placeboDrug
intravenous, once every six months for 15 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.
Annualized relapse rate
Measured: 15 months
Secondary outcomes (4)
Time to confirmed worsening of disability by Expanded Disability Status Scale (EDSS)
Measured: baseline, 15, 24 and 27 months
Time to confirmed worsening of disability by Multiple Sclerosis Functional Composite (MSFC)
Measured: baseline, 15, 24 and 27 months
Proportion of patients relapse-free
Measured: 15, 24, and 27 months
Activity analysis of T2 and Gadolinium enhancing lesions
Measured: 15 and 27 months
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 startNov 2006
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting 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
- 218 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 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
- NCT00869986
- Sponsor's protocol ID
- 12791
- Other IDs
- I3E-BM-MSAE, 2006-001947-70, MBP8298-RR01
- Acronym
- MINDSET01
- Status last verified
- Sep 2010
- First submitted
- 24 Mar 2009
- Last updated
- 9 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
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
- A Double Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00869986
- Acronym / sponsor ID
- MINDSET01 / 12791
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- BioMS Technology Corp.
- Study start
- Nov 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 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 test if dirucotide is safe and effective in treating patients with relapsing remitting multiple sclerosis.
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 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Male or female subjects, 18-50 years of age
- Relapsing-remitting multiple sclerosis (RRMS) according to "Diagnostic criteria for multiple sclerosis: 2005 revisions to the McDonald Criteria" (Annals of Neurology 58: 840-846)
- At least 2 years history of MS before trial entry
- Documented history of 2 or more exacerbations in the 2 years prior to trial entry
- Stable neurological status for at least 30 days before first study drug administration
Key exclusion criteria (16 listed)
- Have Clinically Isolated Syndrome (CIS), Secondary Progressive MS (SPMS), Primary Progressive MS (PPMS)
- Any known malignancy, or history of malignancy, with the exclusion of basal cell carcinoma
- Have active, clinically significant liver, renal or bone marrow disease accompanied with significant laboratory abnormalities in the range of grade I or more as defined by Common Toxicity Criteria (CTC),
- Clinically significant ECG abnormalities at screening
- Have the presence of systemic disease that, in the opinion of the investigator, might interfere with subject safety, compliance or evaluation of the condition under study (e.g. insulin dependent diabetes, lyme disease, clinically significant cardiac, hepatic, or renal disease, Human Immunodeficiency Virus, or Human T-Cell Lymphotrophic Virus Type-1)
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 6 months for 15 months | Drug | Dirucotide |
| placebointravenous, once every six months for 15 months | Drug | Placebo |
Primary outcome
Annualized relapse rate
Time frame: 15 months
4 secondary outcomes
Time to confirmed worsening of disability by Expanded Disability Status Scale (EDSS)
Time frame: baseline, 15, 24 and 27 months
Time to confirmed worsening of disability by Multiple Sclerosis Functional Composite (MSFC)
Time frame: baseline, 15, 24 and 27 months
Proportion of patients relapse-free
Time frame: 15, 24, and 27 months
Activity analysis of T2 and Gadolinium enhancing lesions
Time frame: 15 and 27 months
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 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
6 sites in 6 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 Relapsing Remitting Multiple Sclerosis, run by Eli Lilly and Company at 6 sites in 6 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 13 inclusion and 16 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 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 6 sites in Bulgaria, Poland, Russia, Serbia, Slovakia and 1 more country. 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?
Annualized relapse rate (time frame: 15 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 9 Sep 2010.