Multiple Sclerosis Clinical Trial

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

Summary

Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVaxâ„¢ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 150 subjects with Secondary Progressive SPMS.

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Full Description

The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores.

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Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

150

Study ID:

NCT02149706

Recruitment Status:

Unknown status

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]
Richard Bartholomew, Phd
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

150

Study ID:

NCT02149706

Recruitment Status:

Unknown status

Sponsor:


Immune Response BioPharma, Inc.

How clear is this clinincal trial information?

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