A Study of NeuroVax™, a Novel 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 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | March 2017 |
| End Date: | March 2019 |
| Contact: | Richard M Bartholomew, Ph.D |
| Email: | Richardmbartholomew@gmail.com |
| Phone: | 1-858-414-4664 |
A Phase IIb Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis Slowing Disease Progression Via Vaccination
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.
of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 150 subjects with Secondary
Progressive SPMS.
The primary objective is to compare between treatment groups the Measures of neurologic
disability EDSS scores.
disability EDSS scores.
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
We found this trial at
1
site
Portland, Oregon 97239
Principal Investigator: Dennis Bourdette, FAAN MD
Phone: 858-414-4664
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