Multiple Sclerosis Clinical Trial

A Study of NeuroVaxâ„¢, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis

Summary

A Phase I Study of NeuroVaxâ„¢, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety & efficacy

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Full Description

A Multi-Center Phase I Study of NeuroVaxâ„¢, a Novel Therapeutic TCR Peptide Vaccine for Pediatric Multiple Sclerosis to demonstrate safety & efficacy 12 subjects with pediatric MS

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Eligibility 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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

12

Study ID:

NCT02200718

Recruitment Status:

Not yet recruiting

Sponsor:

Immune Response BioPharma, Inc.

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There is 1 Location for this study

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CRO
San Diego California, 92129, United States More Info
Richard M Bartholomew, PhD
Contact
858-414-4664
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

12

Study ID:

NCT02200718

Recruitment Status:

Not yet recruiting

Sponsor:


Immune Response BioPharma, Inc.

How clear is this clinincal trial information?

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