A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS
A Phase IIb Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis Slowing Disease Progression Via Vaccination
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- NeuroVax
Placebo
- IFA Incomplete Freund's Adjuvant
What it measured
Main measures
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS score
48 Weeks
Disability progression
Other measures (1)
Secondary measurements objectives immunologic evaluations
48 Weeks
Who could take part
Progressive MS · 18 to 70
Show the full criteria
Inclusion criteria
* Ages Eligible for Study: 18 Years to 70 Years * Genders Eligible for Study: Both * Accepts Healthy Volunteers: No Criteria * Subject is between 18 and 70 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
* Subjects currently prescribed Campath or Lemtrada
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. 150 subjects with Secondary Progressive SPMS.
Papers
Loading reviews and guidelines…
History
Started
Mar 2020
Main results due
Mar 2022
Finished
Mar 2022