A Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | February 2017 |
| End Date: | February 2019 |
| Contact: | Richard M Bartholomew, Ph.D |
| Email: | Richardmbartholomew@gmail.com |
| Phone: | 1-858-414-4664 |
A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
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
of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 200 subjects with Secondary
Progressive SPMS
Objectives:The primary objective is to compare between treatment groups the cumulative
number of new gadolinium enhancing (Gd+) lesions on brain MRI at weeks 24, 32, 40 and 48 i n
subjects with secondary progressive MS. Secondary objectives include additional MRI
measurements, analyses of clinical relapses, measures of neurologic disability, immunologic
evaluations, and safety.
Study Design: Multi-center, randomized , double-blind, placebo-controlled , two arm parallel
design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo.
Subject Population: 200 subjects with Secondary Progressive SPMS MS, with an EDSS score >=
3.5 , and meeting all inclusion/exclusion criteria, will be enroll in this study. Subjects
will be randomized equally to NeuroVax™ or I F A
,1 0 0 per arm .
number of new gadolinium enhancing (Gd+) lesions on brain MRI at weeks 24, 32, 40 and 48 i n
subjects with secondary progressive MS. Secondary objectives include additional MRI
measurements, analyses of clinical relapses, measures of neurologic disability, immunologic
evaluations, and safety.
Study Design: Multi-center, randomized , double-blind, placebo-controlled , two arm parallel
design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo.
Subject Population: 200 subjects with Secondary Progressive SPMS MS, with an EDSS score >=
3.5 , and meeting all inclusion/exclusion criteria, will be enroll in this study. Subjects
will be randomized equally to NeuroVax™ or I F A
,1 0 0 per arm .
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
We found this trial at
1
site
Portland, Oregon 97239
Principal Investigator: Dennis Bourdette, F.A.A.N. M.D.
Phone: 1-858-414-4664
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