A Study for Patients With Secondary Progressive Multiple Sclerosis
NCT ID: NCT00869726
Last Updated: 2010-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
596 participants
INTERVENTIONAL
2004-12-31
2009-05-31
Brief Summary
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Dirucotide is generic name for MBP8298.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dirucotide
dirucotide
500mg, intravenous, dosed once every six months for 18 months
Placebo
Placebo
intravenous, once every six months for 18 months
Interventions
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dirucotide
500mg, intravenous, dosed once every six months for 18 months
Placebo
intravenous, once every six months for 18 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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BioMS Technology Corp.
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon-Fri 9am-5pm Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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St. Michaels Hospital
Toronto, Ontario, Canada
Copenhagen University Hospital
Copenhagen, , Denmark
West Tallinn Central Hospital
Tallinn, , Estonia
Terveystalo Turku Kuvantaminen
Turku, , Finland
Heinrich Heine Universitaets
Düsseldorf, , Germany
Vecmilgravis Hospital
Riga, , Latvia
Maaslandziekenhuis
Sittard, , Netherlands
Hospital Duran I Reynals
Barcelona, , Spain
Karolinska Universitetssjukhus
Stockholm, , Sweden
Walton Hospital
Liverpool, , United Kingdom
Countries
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Other Identifiers
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I3E-BM-MSAB
Identifier Type: OTHER
Identifier Source: secondary_id
MBP8298-01
Identifier Type: OTHER
Identifier Source: secondary_id
12788
Identifier Type: -
Identifier Source: org_study_id
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