Status:
UNKNOWN
A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis
Lead Sponsor:
Immune Response BioPharma, Inc.
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
5-17 years
Phase:
PHASE1
Brief Summary
A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety \& efficacy
Detailed Description
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
Eligibility Criteria
Inclusion
- 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
- Subjects currently prescribed Campath or Lemtrada
Key Trial Info
Start Date :
December 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 9 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02200718
Start Date
December 31 2020
End Date
November 9 2024
Last Update
March 31 2020
Active Locations (1)
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1
CRO
San Diego, California, United States, 92129