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MAESTRO-02: A Study for Patients With Multiple Sclerosis

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Terminated
CT.gov ID
NCT00870155
Collaborator
BioMS Technology Corp. (Industry)
546
Enrollment
10
Locations
1
Arm
31
Duration (Months)
54.6
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
546 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label Follow-On Study to Assess the Ongoing Safety of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis
Study Start Date :
Feb 1, 2007
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 6mos until regulatory approval, denial or sponsor termination
Other Names:
  • MBP8298
  • LY2820671

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To assess clinically significant effects of MBP8298 synthetic peptide in all subjects by collecting adverse event, ECG, laboratory, and physical exam outcomes [every 6 mos]

    Secondary Outcome Measures

    1. Degree of change in Kurtzke Expended Disability Status (EDSS) [every 6mos]

    2. Brain atrophy by MRI [every 6mos]

    3. Activity analysis of T2 and Gadolinium enhancing lesions [every 6mos]

    4. Lesion burden [every 6mos]

    5. Degree of change in MS Functional Composite Index (MSFC) [every 6mos]

    6. Relapse rates [every 6mos]

    7. Quality of life as measured by Short Form 36 (SF-36) or MSQoL54 [every 6mos]

    Eligibility Criteria

    Criteria

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

    1. 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",

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

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

    Exclusion Criteria:

    1. 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.

    2. 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.

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

    4. Females who are breast feeding, pregnant or not using a medically approved method of contraception regularly.

    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 North Rhine Westphalia Germany 40225
    6 Vecmilgravis Hospital Riga Latvia 1015
    7 Maaslandziekenhuis Sittard Netherlands 6131BK
    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 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:
    NCT00870155
    Other Study ID Numbers:
    • 12789
    • I3E-BM-MSAC
    • 2007-001480-30
    • MBP8298-SP-02
    First Posted:
    Mar 27, 2009
    Last Update Posted:
    Sep 9, 2010
    Last Verified:
    Sep 1, 2010
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Multiple Sclerosis
    Multiple Sclerosis, Chronic Progressive
    Sclerosis

    Study Results

    No Results Posted as of Sep 9, 2010