A Study for Patients With Multiple Sclerosis (MAESTRO-02)

An Open Label Follow-On Study to Assess the Ongoing Safety of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis

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.

Study Overview

• Status: Terminated
• Conditions: Secondary Progressive Multiple Sclerosis
• Intervention / Treatment: Drug: dirucotide

• Study Type: Interventional
• Enrollment (Anticipated): 546
• 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
  • North Rhine Westphalia
    • Duesseldorf, North Rhine Westphalia, Germany, 40225
      • Heinrich Heine Universitaets
• Latvia
  • Riga, Latvia, 1015
    • Vecmilgravis Hospital
• Netherlands
  • Sittard, Netherlands, 6131BK
    • 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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dirucotide	Drug: dirucotide; 500mg, intravenous, every 6mos until regulatory approval, denial or sponsor termination; Other Names: MBP8298; LY2820671

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Degree of change in Kurtzke Expended Disability Status (EDSS)	every 6mos
Brain atrophy by MRI	every 6mos
Activity analysis of T2 and Gadolinium enhancing lesions	every 6mos
Lesion burden	every 6mos
Degree of change in MS Functional Composite Index (MSFC)	every 6mos
Relapse rates	every 6mos
Quality of life as measured by Short Form 36 (SF-36) or MSQoL54	every 6mos

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: BioMS Technology Corp.

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (ACTUAL): September 1, 2009
• Study Completion (ACTUAL): September 1, 2009

Study Registration Dates

• First Submitted: March 26, 2009
• First Submitted That Met QC Criteria: March 26, 2009
• First Posted (ESTIMATE): March 27, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): September 9, 2010
• Last Update Submitted That Met QC Criteria: September 7, 2010
• Last Verified: September 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: 12789; I3E-BM-MSAC; 2007-001480-30; MBP8298-SP-02