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| ID | Type | Description | Link |
|---|---|---|---|
| IND 77,409 |
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This is a 12-week study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS-0777 tablets | Drug | 0.1 mg, once-weekly, for 12 weeks |
| |
| CS-0777 tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability. | 12 weeks, with 4 weeks to follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic response (lymphocyte counts Pharmacokinetics Exploratory efficacy based on brain MRI lesions) | 12 weeks, with 4 weeks to follow up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver | Colorado | United States | ||||
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C569297 | CS 0777 |
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| Drug |
0.3 mg, once-weekly or once every 2 weeks, for 12 weeks |
|
| CS-0777 tablets | Drug | 0.6 mg, once-weekly or once every 2 weeks, for 12 weeks |
|
| Port Orange |
| Florida |
| United States |
| Lenexa | Kansas | United States |
| Billings | Montana | United States |
| Philadelphia | Pennsylvania | United States |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |