Relapsing Remitting Multiple Sclerosis
Conditions
Brief summary
The purpose of this study is to test if dirucotide is safe and effective in treating patients with relapsing remitting multiple sclerosis.
Interventions
DRUGdirucotide
500mg, intravenous, every 6 months for 15 months
DRUGplacebo
intravenous, once every six months for 15 months
Sponsors
BioMS Technology Corp.
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects, 18-50 years of age 2. Relapsing-remitting multiple sclerosis (RRMS) according to Diagnostic criteria for multiple sclerosis: 2005 revisions to the McDonald Criteria (Annals of Neurology 58: 840-846) 3. At least 2 years history of MS before trial entry 4. Documented history of 2 or more exacerbations in the 2 years prior to trial entry 5. Stable neurological status for at least 30 days before first study drug administration 6. Have an EDSS from 0-5.5 7. If female, she must either * be post-menopausal or surgically sterilized; or * use a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and * be neither pregnant nor breast-feeding 8. Willingness and ability to comply with the protocol for the duration of the study 9. In the Investigator's opinion, subjects must be reliable, compliant, and agree to cooperate with all trial evaluations 10. Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements
Exclusion criteria
1. Have Clinically Isolated Syndrome (CIS), Secondary Progressive MS (SPMS), Primary Progressive MS (PPMS) 2. Any known malignancy, or history of malignancy, with the exclusion of basal cell carcinoma 3. Have active, clinically significant liver, renal or bone marrow disease accompanied with significant laboratory abnormalities in the range of grade I or more as defined by Common Toxicity Criteria (CTC), 4. Clinically significant ECG abnormalities at screening 5. Have the presence of systemic disease that, in the opinion of the investigator, might interfere with subject safety, compliance or evaluation of the condition under study (e.g. insulin dependent diabetes, lyme disease, clinically significant cardiac, hepatic, or renal disease, Human Immunodeficiency Virus, or Human T-Cell Lymphotrophic Virus Type-1) 6. Have current autoimmune disease, compromised immune function or infection 7. History of allergic reactions to glatiramer acetate 8. Steroid therapy within 30 days prior to first study specific procedure, or any other treatment known to be used for putative or experimental MS treatment 9. Therapy with ß-interferon, glatiramer acetate, statins, copaxone or nonspecific phosphodiesterase inhibitors within 3 months prior to first study-specific test 10. Therapy with mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g. IVIG) or immunosuppressive drugs including recombinant or non-recombinant cytokines or plasma exchange within 6 months prior to performance of the first study-specific test, with the exception of corticosteroids or ACTH for relapse treatment 11. Treatment at any time with an altered peptide ligand, cladribine, total lymphoid irradiation, monoclonal anti-body treatment e.g. anti-CD4, anti-CD52, anti-VLA4, Anti-CD20, 12. Any contraindications for MRI, e.g. pacemaker or known allergy to Gadolinium- DTPA 13. Participation in any other trial of an investigational agent within 90 days prior to screening 14. History of alcohol or drug abuse as specified by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) within the year before screening 15. Any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements 16. Any other condition that, in the Investigator's opinion, makes the subject unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized relapse rate | 15 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to confirmed worsening of disability by Expanded Disability Status Scale (EDSS) | baseline, 15, 24 and 27 months |
| Time to confirmed worsening of disability by Multiple Sclerosis Functional Composite (MSFC) | baseline, 15, 24 and 27 months |
| Proportion of patients relapse-free | 15, 24, and 27 months |
| Activity analysis of T2 and Gadolinium enhancing lesions | 15 and 27 months |
Countries
Bulgaria, Poland, Russia, Serbia, Slovakia, Ukraine
Outcome results
None listed