Multiple Sclerosis, Secondary Progress Multiple Sclerosis
Conditions
Keywords
Secondary Progress Multiple Sclerosis, SPMS, Multiple Sclerosis, NeuroVax
Brief summary
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
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 .
Interventions
BIOLOGICALNeuroVax
TCR peptides in IFA
BIOLOGICALIFA Placebo
IFA Placebo
Sponsors
cro
Immune Response BioPharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | up to 48 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunologic evaluations | 48 Weeks | Immunologic evaluations |
| Safety Evaluation | 48 Weeks | Safety Evaluation |
| Secondary MRI measurements objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety. | 48 Weeks | Secondary MRI measurements |
| Analyses of clinical relapses | 48 Weeks | Analyses of clinical relapses |
| Measures of neurologic disability EDSS score | 48 Weeks | Measures of neurologic disability EDSS score |
Countries
United States
Contacts
Primary ContactRichard M Bartholomew, Ph.D
Outcome results
None listed