Multiple Sclerosis
Conditions
Interventions
Product Name: NeuroVax 300ug/mL Dose for IM Injection
Product Code: IR902
Pharmaceutical Form: Emulsion for injection
Current Sponsor code: IR208
Other descriptive name: VB6S5
Concentration unit: µg/m
Sponsors
The Immune Response Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects between 18 and 50 years of age, inclusive. 2. Definite MS by the revised McDonald criteria (2005) (Appendix A), with a relapsing remitting course. 3. Expanded Disability Status Scale (EDSS) score = 5.5 (Appendix B). 4. Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse in the preceding 12 months prior to screening. 5. Laboratory values within the following limits: • Creatinine 9.5 mg/dL • SGOT/SGPT 75,000/mm3 6. Must use effective means of contraception. 7. Must give adequate informed consent and abide by the requirements of the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating female. 2. Clinical relapse or corticosteroid treatment within 30 days prior to screening. 3. Prior use of TCR peptides, T cell vaccines, natalizumab, cladribine, or mitoxantrone. 4. Use of beta interferon, glatiramer acetate, methotrexate, azothioprine, cyclophosphamide, any immunostimulatory, immunosuppressive or immunomodulatory therapy within 90 days of screening. 5. Receipt of any immunizations within 30 days prior to Week 0. 6. Use of any statin class medications within 30 days prior to screening. 7. Any other investigational drug within 30 days prior to screening or planned use during study. 8. Active malignancy (other than squamous or basal cell skin cancer or cancer in situ of the cervix). 9. Any medical condition, which in the judgment of the investigator would put the subject at unacceptable risk for participation in the study or that would confound the results of the study. 10. Active substance abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 in subjects with relapsing remitting MS. ;Secondary Objective: Secondary objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety. ;Primary end point(s): The primary endpoint is the cumulative number of new Gd+ lesions on brain MRI at Week 24, 32, 40, and 48 for each subject. All MRIs shall be evaluated in a blinded manner by the central MRI reading facility. | — |
Countries
Slovakia
Outcome results
None listed