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MINDSET01: A Study for Patients With Relapsing Remitting Multiple Sclerosis

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00869986
Collaborator
BioMS Technology Corp. (Industry)
218
Enrollment
6
Locations
2
Arms
34
Duration (Months)
36.3
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test if dirucotide is safe and effective in treating patients with relapsing remitting multiple sclerosis.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
218 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting Multiple Sclerosis
Study Start Date :
Nov 1, 2006
Actual Primary Completion Date :
Sep 1, 2009
Actual Study Completion Date :
Sep 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dirucotide

Drug: dirucotide
500mg, intravenous, every 6 months for 15 months
Other Names:
  • MBP8298
  • LY2820671

    		•
    Placebo Comparator: Placebo

    Drug: placebo
    intravenous, once every six months for 15 months

    Outcome Measures

    Primary Outcome Measures

    1. Annualized relapse rate [15 months]

    Secondary Outcome Measures

    1. Time to confirmed worsening of disability by Expanded Disability Status Scale (EDSS) [baseline, 15, 24 and 27 months]

    2. Time to confirmed worsening of disability by Multiple Sclerosis Functional Composite (MSFC) [baseline, 15, 24 and 27 months]

    3. Proportion of patients relapse-free [15, 24, and 27 months]

    4. Activity analysis of T2 and Gadolinium enhancing lesions [15 and 27 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or female subjects, 18-50 years of age

    2. Relapsing-remitting multiple sclerosis (RRMS) according to "Diagnostic criteria for multiple sclerosis: 2005 revisions to the McDonald Criteria" (Annals of Neurology 58: 840-846)

    3. At least 2 years history of MS before trial entry

    4. Documented history of 2 or more exacerbations in the 2 years prior to trial entry

    5. Stable neurological status for at least 30 days before first study drug administration

    6. Have an EDSS from 0-5.5

    7. 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

    1. Willingness and ability to comply with the protocol for the duration of the study

    2. In the Investigator's opinion, subjects must be reliable, compliant, and agree to cooperate with all trial evaluations

    3. Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements

    Exclusion Criteria:

    1. Have Clinically Isolated Syndrome (CIS), Secondary Progressive MS (SPMS), Primary Progressive MS (PPMS)

    2. Any known malignancy, or history of malignancy, with the exclusion of basal cell carcinoma

    3. 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),

    4. Clinically significant ECG abnormalities at screening

    5. 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)

    6. Have current autoimmune disease, compromised immune function or infection

    7. History of allergic reactions to glatiramer acetate

    8. 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

    9. Therapy with ß-interferon, glatiramer acetate, statins, copaxone or nonspecific phosphodiesterase inhibitors within 3 months prior to first study-specific test

    10. 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

    11. 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,

    12. Any contraindications for MRI, e.g. pacemaker or known allergy to Gadolinium- DTPA

    13. Participation in any other trial of an investigational agent within 90 days prior to screening

    14. 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

    15. 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

    16. Any other condition that, in the Investigator's opinion, makes the subject unsuitable for participation in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Military Medical Academy Sofia Bulgaria
    2 Silesian Medical School Katowice Poland
    3 Clinical City Hospital No. 11 Moscow Russian Federation
    4 Clinical Center of Serbia Belgrade Serbia
    5 FNsP J A Reimana Presov Slovakia
    6 Vinnitsa State Medical University Vinnitsa Ukraine

    Sponsors and Collaborators

    • Eli Lilly and Company
    • BioMS Technology Corp.

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am - 5pm Eastern Time (UTC/GMT)-5 hours,EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00869986
    Other Study ID Numbers:
    • 12791
    • I3E-BM-MSAE
    • 2006-001947-70
    • MBP8298-RR01
    First Posted:
    Mar 26, 2009
    Last Update Posted:
    Sep 9, 2010
    Last Verified:
    Sep 1, 2010
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Multiple Sclerosis, Relapsing-Remitting
    Sclerosis

    Study Results

    No Results Posted as of Sep 9, 2010