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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02200718 |
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Date of registration:
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17/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis
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Scientific title:
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A Phase I Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis |
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Date of first enrolment:
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December 31, 2020 |
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Target sample size:
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12 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02200718 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Richard M Bartholomew, Ph.D |
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Address:
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Telephone:
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1-858-414-4664 |
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Email:
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Richardmbartholomew@gmail.com |
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Affiliation:
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Name:
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Richard M Bartholomew, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Immune Response BioPharma, Inc. |
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Name:
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Richard M Bartholomew, PhD |
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Address:
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Telephone:
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858-414-4664 |
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Email:
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Richardmbartholomew@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
5 Years
Age maximum:
17 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Biological: IFA Incomplete Freund's Adjuvant
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Biological: NeuroVax
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Primary Outcome(s)
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The primary clinical endpoints are comparisons of MRI & WBC measurements between the treatment groups
[Time Frame: 26 Weeks]
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Secondary Outcome(s)
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A Secondary clinical endpoint is the measurement of FOXP3+ expression
[Time Frame: 26 Weeks]
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A Secondary clinical endpoint is the measurement of clinical relapses
[Time Frame: 26 Weeks]
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A Secondary clinical endpoint is the measurment of EDSS scores
[Time Frame: 26 Weeks]
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Secondary ID(s)
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IR902-007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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