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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This is a phase 2, randomized, double-blind, parallel-group, single dose study to evaluate the safety and efficacy of 2 dose levels of REGN475 compared with placebo in patients with sciatic pain. Enrollment of approximately 50 patients in each of the 3 treatment arms is expected at up to 35 US sites, for a total enrollment of approximately 150 patients. Patients will receive 1 injection under the skin of either active or placebo REGN475, and be followed over 10 visits for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo injection | Placebo Comparator |
| |
| active | Experimental | subcutaneous injection of REGN475 |
|
| active 2 | Experimental | subcutaneous injection of REGN475 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN475 | Drug | Single Subcutaneous injection dose level 1 |
| |
| REGN475 |
| Measure | Description | Time Frame |
|---|---|---|
| Sciatic pain between baseline and end of week 4 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Additional measures of sciatic pain. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Tiseo, PhD | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Investigational Site | Birmingham | Alabama | United States | |||
| Regeneron Investigational Site |
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| Drug |
Single subcutaneous injection dose level 2 |
|
| Placebo Injection | Drug | Placebo Subcutaneous injection |
|
| Mobile |
| Alabama |
| United States |
| Regeneron Investigational Site | Peoria | Arizona | United States |
| Regeneron Investigational Site | Anaheim | California | United States |
| Regeneron Investigational Site | Beverly Hills | California | United States |
| Regeneron Investigational Site | National City | California | United States |
| Regeneron Investigational Site | Santa Ana | California | United States |
| Regeneron Investigational Site | Milford | Connecticut | United States |
| Regeneron Investigational Site | Stamford | Connecticut | United States |
| Regeneron Investigational Site | Clearwater | Florida | United States |
| Regeneron Investigational Site | Hallandale | Florida | United States |
| Regeneron Investigational Site | St. Petersburg | Florida | United States |
| Regeneron Investigational Site | Tampa | Florida | United States |
| Regeneron Investigational Site | West Palm Beach | Florida | United States |
| Regeneron Investigational Site | Atlanta | Georgia | United States |
| Regeneron Investigational Site | Sandy Springs | Georgia | United States |
| Regeneron Investigational Site | Overland Park | Kansas | United States |
| Regeneron Investigational Site | Rockville | Maryland | United States |
| Regeneron Investigational Site | Kansas City | Missouri | United States |
| Regeneron Investigational Site | Albuquerque | New Mexico | United States |
| Regeneron Investigational Site | Raleigh | North Carolina | United States |
| Regeneron Investigational Site | Cincinnati | Ohio | United States |
| Regeneron Investigational Site | Duncansville | Pennsylvania | United States |
| Regeneron Investigational Site | Tyrone | Pennsylvania | United States |
| Regeneron Investigational Site | Warwick | Rhode Island | United States |
| Regeneron Investigational Site | Greer | South Carolina | United States |
| Regeneron Investigational Site | Memphis | Tennessee | United States |
| Regeneron Investigational Site | El Paso | Texas | United States |
| Regeneron Investigational Site | San Antonio | Texas | United States |
| Regeneron Invesitgational Site | West Jordan | Utah | United States |
| ID | Term |
|---|---|
| D012585 | Sciatica |
| D010146 | Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000626997 | fasinumab |
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