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| Sponsor: | Eli Lilly and Company |
|---|---|
| Collaborator: |
BioMS Technology Corp. |
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00869986 |
Purpose
The purpose of this study is to test if dirucotide is safe and effective in treating patients with relapsing remitting multiple sclerosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsing Remitting Multiple Sclerosis |
Drug: dirucotide Drug: placebo |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Relapsing Remitting Multiple Sclerosis |
| Enrollment: | 218 |
| Study Start Date: | November 2006 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dirucotide |
Drug: dirucotide
500mg, intravenous, every 6 months for 15 months
Other Names:
|
| Placebo Comparator: Placebo |
Drug: placebo
intravenous, once every six months for 15 months
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
If female, she must either
Exclusion Criteria:
Contacts and Locations| Bulgaria | |
| Military Medical Academy | |
| Sofia, Bulgaria | |
| Poland | |
| Silesian Medical School | |
| Katowice, Poland | |
| Russian Federation | |
| Clinical City Hospital No. 11 | |
| Moscow, Russian Federation | |
| Serbia | |
| Clinical Center of Serbia | |
| Belgrade, Serbia | |
| Slovakia | |
| FNsP J A Reimana | |
| Presov, Slovakia | |
| Ukraine | |
| Vinnitsa State Medical University | |
| Vinnitsa, Ukraine | |
| Study Director: | 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 |
More Information
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00869986 History of Changes |
| Other Study ID Numbers: | 12791, I3E-BM-MSAE, 2006-001947-70, MBP8298-RR01 |
| Study First Received: | March 24, 2009 |
| Last Updated: | September 7, 2010 |
| Health Authority: | United States: Food and Drug Administration; Bulgaria: Ministry of Health; Poland: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Slovakia: State Institute for Drug Control; Ukraine: State Pharmacological Center - Ministry of Health |
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |