A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pedi
A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- NeuroVax
Placebo
- IFA Incomplete Freund's Adjuvant
What it measured
Main measures
The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups
26 Weeks
MRI lesions
Other measures (3)
A Secondary clinical endpoint is the measurement of FOXP3+ expression
26 Weeks
A Secondary clinical endpoint is the measurment of EDSS scores
26 Weeks
Disability progressionWalking and mobilityA Secondary clinical endpoint is the measurement of clinical relapses
26 Weeks
Relapses
Who could take part
MS (type not specified) · 5 to 17
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety \& efficacy
Papers
Loading reviews and guidelines…
History
Started
Dec 2020
Main results due
Nov 2024
Finished
Nov 2024