A Study for Patients With Secondary Progressive Multiple Sclerosis

NCT00869726 | Completed Phase 2 DMC

• 3 other identifiers: 12788I3E-BM-MSABMBP8298-01
• Study Type: interventional
• Target: 596
• Locations: 9 countries
• Sites: 9

Brief Summary

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.

Conditions

Secondary Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS).

  baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos

Secondary Outcomes (7)

• 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

Study Arms (2)

Dirucotide

EXPERIMENTAL

Drug: dirucotide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

dirucotide DRUG

500mg, intravenous, dosed once every six months for 18 months

Also known as: MBP8298, LY2820671

Dirucotide

Placebo DRUG

intravenous, once every six months for 18 months

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of Primary Progressive MS
• Subjects have previously received MBP8298
• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• BioMS Technology Corp.: collaborator

Study Sites (10)

St. Michaels Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

West Tallinn Central Hospital

Tallinn, 10617, Estonia

Location

Terveystalo Turku Kuvantaminen

Turku, 20101, Finland

Location

Heinrich Heine Universitaets

Düsseldorf, 40225, Germany

Location

Vecmilgravis Hospital

Riga, 1015, Latvia

Location

Maaslandziekenhuis

Sittard, 6131 BK, Netherlands

Location

Hospital Duran I Reynals

Barcelona, 08907, Spain

Location

Karolinska Universitetssjukhus

Stockholm, 14186, Sweden

Location

Walton Hospital

Liverpool, L97LJ, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

MBP-8298

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 26, 2009
• Study Start: December 1, 2004
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 2, 2010

Record last verified: 2010-05

Locations

DK (1); ES (1); GB (1); LA (1); DE (1); SE (1); NL (1); FI (1); CA (1)