Clinical Trial: A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis
Brief Summary: A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety & efficacy
Detailed Summary: 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
Sponsor: Immune Response BioPharma, Inc.
Current Primary Outcome: The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups [ Time Frame: 26 Weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- A Secondary clinical endpoint is the measurement of FOXP3+ expression [ Time Frame: 26 Weeks ]Secondary measurements objectives to compare immunologic evaluations increases in FOXP3+ expression between treatment groups
- A Secondary clinical endpoint is the measurment of EDSS scores [ Time Frame: 26 Weeks ]To compare between treatment groups the Measures of neurologic disability EDSS scores utilizing the Kurtzke scale, Patients will be assessed using the EDSS, a 25-foot timed walk, and a nine-hole peg test assessments at weeks 0, 4, 8, 12, 16, 20 & 26 visit then exit the study.
- A Secondary clinical endpoint is the measurement of clinical relapses [ Time Frame: 26 Weeks ]To compare the Analysis of clinical relapses between the treatment groups of Pediatric MS subjects at week 26
Original Secondary Outcome: Same as current
Information By: Immune Response BioPharma, Inc.
Dates:
Date Received: July 17, 2014
Date Started: November 2017
Date Completion: November 2019
Last Updated: February 22, 2016
Last Verified: February 2016