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A Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified February 2016 by Immune Response BioPharma, Inc.
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Immune Response BioPharma, Inc.
ClinicalTrials.gov Identifier:
NCT02057159
First received: February 4, 2014
Last updated: February 22, 2016
Last verified: February 2016
  Purpose
Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 200 subjects with Secondary Progressive SPMS

Condition Intervention Phase
Secondary Progress Multiple Sclerosis Multiple Sclerosis Biological: NeuroVax Biological: IFA Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Immune Response BioPharma, Inc.:

Primary Outcome Measures:
  • The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI at up to 48 weeks in subjects with secondary progressive MS [ Time Frame: up to 48 weeks ]

Secondary Outcome Measures:
  • Secondary MRI measurements objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety. [ Time Frame: 48 Weeks ]
    Secondary MRI measurements

  • Analyses of clinical relapses [ Time Frame: 48 Weeks ]
    Analyses of clinical relapses

  • Measures of neurologic disability EDSS score [ Time Frame: 48 Weeks ]
    Measures of neurologic disability EDSS score

  • Immunologic evaluations [ Time Frame: 48 Weeks ]
    Immunologic evaluations

  • Safety [ Time Frame: 48 Weeks ]
    Safety


Estimated Enrollment: 200
Study Start Date: February 2017
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NeuroVax
NeuroVax
Biological: NeuroVax
Placebo Comparator: IFA Placebo
IFA Placebo
Biological: IFA Placebo
IFA Placebo

Detailed Description:

Objectives:The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI at weeks 24, 32, 40 and 48 i n subjects with secondary progressive MS. Secondary objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.

Study Design: Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo.

Subject Population: 200 subjects with Secondary Progressive SPMS MS, with an EDSS score >= 3.5 , and meeting all inclusion/exclusion criteria, will be enroll in this study. Subjects will be randomized equally to NeuroVax™ or I F A

,1 0 0 per arm .

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is between 18 and 50 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02057159

Contacts
Contact: Richard M Bartholomew, Ph.D 1-858-414-4664 Richardmbartholomew@gmail.com

Locations
United States, Oregon
Multiple Sclerosis Center Oregon Health & Science University Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Richard M Bartholomew, PhD    1-858-414-4664    Richardmbartholomew@gmail.com   
Principal Investigator: Dennis Bourdette, F.A.A.N. M.D.         
Sponsors and Collaborators
Immune Response BioPharma, Inc.
Oregon Health and Science University
Investigators
Study Director: Richard M Bartholomew, Ph.D Immune Response BioPharma, Inc.
  More Information

Additional Information:
Responsible Party: Immune Response BioPharma, Inc.
ClinicalTrials.gov Identifier: NCT02057159     History of Changes
Other Study ID Numbers: IR902-231
Study First Received: February 4, 2014
Last Updated: February 22, 2016

Keywords provided by Immune Response BioPharma, Inc.:
Secondary Progress Multiple Sclerosis
SPMS
Multiple Sclerosis
NeuroVax

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 22, 2017