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| ID | Type | Description | Link |
|---|---|---|---|
| I3E-BM-MSAB | Other Identifier | Eli Lilly and Company | |
| MBP8298-01 | Other Identifier | BioMS Technology Corp. |
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| Name | Class |
|---|---|
| BioMS Technology Corp. | INDUSTRY |
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The purpose of this study is to determine whether MBP8298 is effective and safe in the treatment secondary progressive multiple sclerosis.
Dirucotide is generic name for MBP8298.
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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, dosed once every six months for 18 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS). | baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos |
| Measure | Description | Time Frame |
|---|---|---|
| degree of change in EDSS | baseline, 24mos | |
| Brain Atrophy by MRI | baseline, 12mos, 24mos | |
| Activity analysis of T2 and Gadolinium enhancing lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 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 |
|---|---|---|---|---|---|---|
| St. Michaels Hospital | Toronto | Ontario | M5B 1W8 | Canada | ||
| Copenhagen University Hospital |
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| ID | Term |
|---|---|
| D020528 | Multiple Sclerosis, Chronic Progressive |
| 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 18 months |
|
| 12mos and 24mos |
| Lesion burden | 12mos and 24mos |
| Degree of change in MS Functional Composite Index (MSFC) | baseline, 3mos, 6mos, 9mos, 12mos, 15mos, 18mos, 21mos, 24mos |
| Relapse rates | baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos |
| Quality of life as measured by Short Form 36 (SF-36) or MSQoL54 | baseline, 6mos, 12mos, 18mos, 24mos |
| Copenhagen |
| 2100 |
| Denmark |
| West Tallinn Central Hospital | Tallinn | 10617 | Estonia |
| Terveystalo Turku Kuvantaminen | Turku | 20101 | Finland |
| Heinrich Heine Universitaets | Düsseldorf | 40225 | Germany |
| Vecmilgravis Hospital | Riga | 1015 | Latvia |
| Maaslandziekenhuis | Sittard | 6131 BK | Netherlands |
| Hospital Duran I Reynals | Barcelona | 08907 | Spain |
| Karolinska Universitetssjukhus | Stockholm | 14186 | Sweden |
| Walton Hospital | Liverpool | L97LJ | United Kingdom |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |