A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis



Status:Not yet recruiting
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:5 - 17
Updated:4/21/2016
Start Date:November 2017
End Date:November 2019
Contact:Richard M Bartholomew, Ph.D
Email:Richardmbartholomew@gmail.com
Phone:1-858-414-4664

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis

A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple
Sclerosis to demonstrate safety & efficacy

A Multi-Center Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for
Pediatric Multiple Sclerosis to demonstrate safety & efficacy 12 subjects with pediatric MS

Inclusion Criteria:

- Ages Eligible for Study: 5 Years to 17 Years

- Genders Eligible for Study: Both

- Accepts Healthy Volunteers: No Criteria

- Subject is between 5 and 17 years of age, inclusive

- Clinically diagnosed Pediatric MS

- Definite Pediatric MS by the revised McDonald criteria (2005) (Appendix A), with a
pediatric MS course

- Expanded Disability Status Scale (EDSS) <= score 6.5 (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 12 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
Multiple Sclerosis Center Oregon Health & Science University
Portland, Oregon 97239
Principal Investigator: Dennis Bourdette, MD F.A.A.N.
Phone: 858-414-4664
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mi
from
Portland, OR
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