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

This study has been completed.
Sponsor:
Collaborator:
BioMS Technology Corp.
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00869726
First received: March 24, 2009
Last updated: May 27, 2010
Last verified: May 2010

March 24, 2009
May 27, 2010
December 2004
May 2009   (final data collection date for primary outcome measure)
Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS). [ Time Frame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00869726 on ClinicalTrials.gov Archive Site
  • degree of change in EDSS [ Time Frame: baseline, 24mos ] [ Designated as safety issue: No ]
  • Brain Atrophy by MRI [ Time Frame: baseline, 12mos, 24mos ] [ Designated as safety issue: No ]
  • Activity analysis of T2 and Gadolinium enhancing lesions [ Time Frame: 12mos and 24mos ] [ Designated as safety issue: No ]
  • Lesion burden [ Time Frame: 12mos and 24mos ] [ Designated as safety issue: No ]
  • Degree of change in MS Functional Composite Index (MSFC) [ Time Frame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos, 18mos, 21mos, 24mos ] [ Designated as safety issue: No ]
  • Relapse rates [ Time Frame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos ] [ Designated as safety issue: No ]
  • Quality of life as measured by Short Form 36 (SF-36) or MSQoL54 [ Time Frame: baseline, 6mos, 12mos, 18mos, 24mos ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study for Patients With Secondary Progressive Multiple Sclerosis
A Double-Blind, Placebo Controlled Multicentre Study To Evaluate The Efficacy And Safety Of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Secondary Progressive Multiple Sclerosis
  • Drug: dirucotide
    500mg, intravenous, dosed once every six months for 18 months
    Other Names:
    • MBP8298
    • LY2820671
  • Drug: Placebo
    intravenous, once every six months for 18 months
  • Experimental: Dirucotide
    Intervention: Drug: dirucotide
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
596
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Denmark,   Estonia,   Finland,   Germany,   Latvia,   Netherlands,   Spain,   Sweden,   United Kingdom
 
NCT00869726
12788, I3E-BM-MSAB, MBP8298-01
Yes
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
BioMS Technology Corp.
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
Eli Lilly and Company
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP