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| ID | Type | Description | Link |
|---|---|---|---|
| I3E-BM-MSAE | |||
| 2006-001947-70 | |||
| MBP8298-RR01 |
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| Name | Class |
|---|---|
| BioMS Technology Corp. | INDUSTRY |
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The purpose of this study is to test if dirucotide is safe and effective in treating patients with relapsing remitting multiple sclerosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dirucotide | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dirucotide | Drug | 500mg, intravenous, every 6 months for 15 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized relapse rate | 15 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Male or female subjects, 18-50 years of age
Relapsing-remitting multiple sclerosis (RRMS) according to "Diagnostic criteria for multiple sclerosis: 2005 revisions to the McDonald Criteria" (Annals of Neurology 58: 840-846)
At least 2 years history of MS before trial entry
Documented history of 2 or more exacerbations in the 2 years prior to trial entry
Stable neurological status for at least 30 days before first study drug administration
Have an EDSS from 0-5.5
If female, she must either
Willingness and ability to comply with the protocol for the duration of the study
In the Investigator's opinion, subjects must be reliable, compliant, and agree to cooperate with all trial evaluations
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:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am - 5pm Eastern Time (UTC/GMT)-5 hours,EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Military Medical Academy | Sofia | Bulgaria | ||||
| Silesian Medical School |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C526227 | MBP-8298 |
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| placebo | Drug | intravenous, once every six months for 15 months |
|
| Proportion of patients relapse-free | 15, 24, and 27 months |
| Activity analysis of T2 and Gadolinium enhancing lesions | 15 and 27 months |
| Katowice |
| Poland |
| Clinical City Hospital No. 11 | Moscow | Russia |
| Clinical Center of Serbia | Belgrade | Serbia |
| FNsP J A Reimana | Prešov | Slovakia |
| Vinnitsa State Medical University | Vinnitsa | Ukraine |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |