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| Name | Class |
|---|---|
| cro | AMBIG |
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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.
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeuroVax | Experimental | NeuroVax |
|
| IFA Incomplete Freund's Adjuvant | Placebo Comparator | Incomplete Freund's Adjuvant IFA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroVax | Biological | NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS score | The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores improvements | 48 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary measurements objectives immunologic evaluations | Secondary measurements objectives immunologic evaluations increases in white blood cell counts & FOXP+3 expression increases | 48 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard M Bartholomew, Ph.D | Contact | 1-858-414-4664 | Richardmbartholomew@gmail.com | |
| Richard Bartholomew | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Richard M Bartholomew, Ph.D | Immune Response BioPharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRO | San Diego | California | 92129 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C508473 | NeuroVax vaccine |
| C098825 | HIV-1 immunogen, incomplete Freund's adjuvant |
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| IFA Incomplete Freund's Adjuvant |
| Biological |
IFA Placebo Incomplete Freund's Adjuvant |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |