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Completed

NCT Number: NCT00869726

A Study for Patients 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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

St. Michaels Hospital, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dirucotide

Drug

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

Other names: MBP8298, LY2820671

Placebo

Drug

intravenous, once every six months for 18 months

Primary outcomes

  1. 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

Secondary outcomes

  1. degree of change in EDSS

    Time frame: baseline, 24mos

  2. Brain Atrophy by MRI

    Time frame: baseline, 12mos, 24mos

  3. Activity analysis of T2 and Gadolinium enhancing lesions

    Time frame: 12mos and 24mos

  4. Lesion burden

    Time frame: 12mos and 24mos

  5. Degree of change in MS Functional Composite Index (MSFC)

    Time frame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos, 18mos, 21mos, 24mos

  6. Relapse rates

    Time frame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos

  7. Quality of life as measured by Short Form 36 (SF-36) or MSQoL54

    Time frame: baseline, 6mos, 12mos, 18mos, 24mos

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • BioMS Technology Corp.

Registry information

Official study title

A Double-Blind, Placebo Controlled Multicentre Study To Evaluate The Efficacy And Safety Of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis

Acronym: MAESTRO-01

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Mar 26, 2009
Registry last updated
Jun 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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