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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: |
NCT02149706 |
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Date of registration:
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24/05/2014 |
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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 SPMS of Multiple Sclerosis
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Scientific title:
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A Phase IIb Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis Slowing Disease Progression Via Vaccination |
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Date of first enrolment:
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March 9, 2020 |
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Target sample size:
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150 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02149706 |
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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 2
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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, 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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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, 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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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Ages Eligible for Study: 18 Years to 70 Years
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: No Criteria
- Subject is between 18 and 70 years of age, inclusive.
- Definite MS by the revised McDonald criteria (2005) (Appendix A), with a Secondary
Progressive course.
- Expanded Disability Status Scale (EDSS) >=score 3.5 (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 1 2 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:
18 Years
Age maximum:
70 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 objective is to compare between treatment groups the Measures of neurologic disability EDSS score
[Time Frame: 48 Weeks]
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Secondary Outcome(s)
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Secondary measurements objectives immunologic evaluations
[Time Frame: 48 Weeks]
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Secondary ID(s)
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Immune Response 2020
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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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