A Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Mu

A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis

Status unknownPhase 2Phase 3Progressive MSNCT02057159

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • NeuroVax

Placebo

  • IFA Placebo

What it measured

Main measures

  • The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI at up to 48 weeks in subjects with secondary progressive MS

    up to 48 weeks

    MRI lesions

Other measures (5)

  • Secondary MRI measurements objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.

    48 Weeks

    RelapsesMRI lesionsSafety

  • Analyses of clinical relapses

    48 Weeks

    Relapses

  • Measures of neurologic disability EDSS score

    48 Weeks

    Disability progression

  • Immunologic evaluations

    48 Weeks

  • Safety Evaluation

    48 Weeks

    Safety

Who could take part

Progressive MS · 18 to 50

Show the full criteria

Inclusion criteria

* Subject is between 18 and 50 years of age, inclusive. * Definite MS by the revised McDonald criteria (2005) (Appendix A), with a Secondary Progressive course. * Expanded Disability Status Scale (EDSS) >=score 3.5 (Appendix B). * Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 1 2 months prior to screening . * Laboratory values within the following limits: * Creatinine 1 . 5 x high normal. * Hemoglobin

Exclusion criteria

Not separately supplied in the registry.

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

About this trial

In the sponsor's words

Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 200 subjects with Secondary Progressive SPMS

Papers

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    History

      1. Started

        Mar 2020

      2. Main results due

        Mar 2023

      3. Finished

        Mar 2023

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