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

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.

Study Overview

• Status: Completed
• Conditions: Secondary Progressive Multiple Sclerosis
• Intervention / Treatment: Drug: dirucotide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 596
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michaels Hospital
• Denmark
  • Kobenhavn, Denmark, 2100
    • Copenhagen University Hospital
• Estonia
  • Tallinn, Estonia, 10617
    • West Tallinn Central Hospital
• Finland
  • Turku, Finland, 20101
    • Terveystalo Turku Kuvantaminen
• Germany
  • Duesseldorf, Germany, 40225
    • Heinrich Heine Universitaets
• Latvia
  • Riga, Latvia, 1015
    • Vecmilgravis Hospital
• Netherlands
  • Sittard, Netherlands, 6131 BK
    • Maaslandziekenhuis
• Spain
  • Barcelona, Spain, 08907
    • Hospital Duran i Reynals
• Sweden
  • Stockholm, Sweden, 14186
    • Karolinska Universitetssjukhus
• United Kingdom
  • Liverpool, United Kingdom, L97LJ
    • Walton Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; intravenous, once every six months for 18 months
Experimental: Dirucotide	Drug: dirucotide; 500mg, intravenous, dosed once every six months for 18 months; Other Names: MBP8298; LY2820671

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
degree of change in EDSS	baseline, 24mos
Brain Atrophy by MRI	baseline, 12mos, 24mos
Activity analysis of T2 and Gadolinium enhancing lesions	12mos and 24mos
Lesion burden	12mos and 24mos
Degree of change in MS Functional Composite Index (MSFC)	baseline, 3mos, 6mos, 9mos, 12mos, 15mos, 18mos, 21mos, 24mos
Relapse rates	baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos
Quality of life as measured by Short Form 36 (SF-36) or MSQoL54	baseline, 6mos, 12mos, 18mos, 24mos

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: 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 record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: March 24, 2009
• First Submitted That Met QC Criteria: March 24, 2009
• First Posted (Estimate): March 26, 2009

Study Record Updates

• Last Update Posted (Estimate): June 2, 2010
• Last Update Submitted That Met QC Criteria: May 27, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Neoplasms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neoplastic Processes; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; Neoplasm Metastasis
• Other Study ID Numbers: 12788; I3E-BM-MSAB (Other Identifier: Eli Lilly and Company); MBP8298-01 (Other Identifier: BioMS Technology Corp.)