CompletedPhase 2Phase 3Progressive MSNCT008697262004-002571-16

What it found

Missed its main goal

The main measure did not show a significant benefit.

“Results There were no significant differences between treatment groups in either the primary or secondary endpoints.”
Read by software from the paper's abstract

time to progression by ≥1.0 EDSS point (or 0.5 point if baseline EDSS was 5.5 or higher), confirmed 6 months later · 2 years

Total participants: 612

Read by software from the paper's abstract

This trial finished 17 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Dirucotide

Placebo or sham

  • Placebo

What it measured

Main measures

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

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

    Disability progression
  • The primary endpoint is a statistically and clinically significant increase in the time to confirmed worsening of disability as measured by EDSS.

    Disability progression

Other measures (7)

  • degree of change in EDSS

    baseline, 24mos

    Disability progression
  • Brain Atrophy by MRI

    baseline, 12mos, 24mos

    MRI lesionsBrain volume loss
  • Activity analysis of T2 and Gadolinium enhancing lesions

    12mos and 24mos

    MRI lesions
  • Lesion burden

    12mos and 24mos

    MRI lesions
  • Degree of change in MS Functional Composite Index (MSFC)

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

    Disability progression
  • Relapse rates

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

    Relapses
  • Quality of life as measured by Short Form 36 (SF-36) or MSQoL54

    baseline, 6mos, 12mos, 18mos, 24mos

    Quality of life (reported by participants)

Who could take part

Progressive MS · 18 to 65

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    Related trials

    History

      1. Started

        Dec 2004

      2. Main results due

        May 2009

      3. Finished

        May 2009

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