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MAESTRO-01: A Study for Patients With Secondary Progressive Multiple Sclerosis

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00869726
Collaborator
BioMS Technology Corp. (Industry)
596
Enrollment
10
Locations
2
Arms
53
Duration (Months)
59.6
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Study Design

Study Type:
Interventional
Actual Enrollment :
596 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 Multicentre Study To Evaluate The Efficacy And Safety Of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis
Study Start Date :
Dec 1, 2004
Actual Primary Completion Date :
May 1, 2009
Actual Study Completion Date :
May 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dirucotide

Drug: dirucotide
500mg, intravenous, dosed once every six months for 18 months
Other Names:
  • MBP8298
  • LY2820671

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    intravenous, once every six months for 18 months

    Outcome Measures

    Primary Outcome Measures

    1. Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS). [baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos]

    Secondary Outcome Measures

    1. degree of change in EDSS [baseline, 24mos]

    2. Brain Atrophy by MRI [baseline, 12mos, 24mos]

    3. Activity analysis of T2 and Gadolinium enhancing lesions [12mos and 24mos]

    4. Lesion burden [12mos and 24mos]

    5. Degree of change in MS Functional Composite Index (MSFC) [baseline, 3mos, 6mos, 9mos, 12mos, 15mos, 18mos, 21mos, 24mos]

    6. Relapse rates [baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos]

    7. Quality of life as measured by Short Form 36 (SF-36) or MSQoL54 [baseline, 6mos, 12mos, 18mos, 24mos]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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.

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Michaels Hospital Toronto Ontario Canada M5B 1W8
    2 Copenhagen University Hospital Kobenhavn Denmark 2100
    3 West Tallinn Central Hospital Tallinn Estonia 10617
    4 Terveystalo Turku Kuvantaminen Turku Finland 20101
    5 Heinrich Heine Universitaets Duesseldorf Germany 40225
    6 Vecmilgravis Hospital Riga Latvia 1015
    7 Maaslandziekenhuis Sittard Netherlands 6131 BK
    8 Hospital Duran I Reynals Barcelona Spain 08907
    9 Karolinska Universitetssjukhus Stockholm Sweden 14186
    10 Walton Hospital Liverpool United Kingdom L97LJ

    Sponsors and Collaborators

    • Eli Lilly and Company
    • BioMS Technology Corp.

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 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:
    NCT00869726
    Other Study ID Numbers:
    • 12788
    • I3E-BM-MSAB
    • MBP8298-01
    First Posted:
    Mar 26, 2009
    Last Update Posted:
    Jun 2, 2010
    Last Verified:
    May 1, 2010
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Multiple Sclerosis
    Multiple Sclerosis, Chronic Progressive
    Sclerosis

    Study Results

    No Results Posted as of Jun 2, 2010