Stopped earlyPhase 2Phase 3Progressive MSNCT00870155

What it found

Stopped: not working

The trial was stopped early because the treatment was not working.

Reason given: Negative efficacy results of the MAESTRO-01 trial

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

What it measured

Main measures

  • 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

    Safety

Other measures (7)

  • Degree of change in Kurtzke Expended Disability Status (EDSS)

    every 6mos

    Disability progression
  • Brain atrophy by MRI

    every 6mos

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

    every 6mos

    MRI lesions
  • Lesion burden

    every 6mos

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

    every 6mos

    Disability progression
  • Relapse rates

    every 6mos

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

    every 6mos

    Quality of life (reported by participants)

Who could take part

Progressive MS · 18 to 65

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.

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

About this trial

In the sponsor's words

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.

Papers

    Loading reviews and guidelines…

    Related trials

    History

      1. Started

        Feb 2007

      2. Main results due

        Sept 2009

      3. Finished

        Sept 2009

      Assembled by software from public sources and not checked by people. Each record links to its source. Report an error