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The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine in participants with pain associated with diabetic peripheral neuropathy (DPN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suzetrigine (SUZ) | Experimental | Participants will be randomized to receive SUZ. |
|
| Placebo | Placebo Comparator | Participants will be randomized to receive placebo matched to SUZ. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suzetrigine | Drug | Tablets for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo | From Baseline up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Medical Outcomes Study 36-item Short-form Health Status (SF-36v2) Physical Component Summary (PCS) Score at Week 12 Compared to Placebo (Pooled with data from Study VX24-548-110) | From Baseline up to Week 12 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Contact | 6173416777 | medicalinfo@vrtx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Associates, LLC | Recruiting | Birmingham | Alabama | 35205 | United States | |
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
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| Placebo (matched to SUZ) | Drug | Placebo matched to SUZ for oral administration. |
|
| Accel Research - Birmingham |
| Recruiting |
| Birmingham |
| Alabama |
| 35216 |
| United States |
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| Marvel Clinical Research | Recruiting | Huntington Beach | California | 92647 | United States |
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| Artemis Institute for Clinical Research - Riverside | Recruiting | Riverside | California | 92503 | United States |
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| Paradigm Clinical Research - Wheat Ridge | Recruiting | Wheat Ridge | Colorado | 80033 | United States |
| Chase Medical Research | Recruiting | Waterbury | Connecticut | 06708 | United States |
| Velocity Clinical Research - Washington DC | Recruiting | Washington D.C. | District of Columbia | 20016 | United States |
| Neurology Offices of South Florida, PLLC | Recruiting | Boca Raton | Florida | 33428 | United States |
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| Velocity Clinical Research - Hallandale Beach | Recruiting | Hallandale | Florida | 33009 | United States |
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| Aqualane Clinical Research | Recruiting | Naples | Florida | 34105 | United States |
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| Suncoast Clinical Research - Palm Harbor | Recruiting | Palm Harbor | Florida | 34684 | United States |
| 3Sync Research - Palm Springs | Recruiting | Palm Springs | Florida | 33461 | United States |
| Health Awareness, Inc. - Port St. Lucie | Recruiting | Port Saint Lucie | Florida | 34952 | United States |
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| Accel Research - Decatur | Recruiting | Decatur | Georgia | 30030 | United States |
| Javara Inc./Privia Medical Group - Fayetteville, GA | Recruiting | Fayetteville | Georgia | 30214 | United States |
| Velocity Clinical Research - Savannah | Recruiting | Savannah | Georgia | 31406 | United States |
| Healthcare Research Network - Flossmoor IL | Recruiting | Tinley Park | Illinois | 60477 | United States |
| Velocity Clinical Research - Baton Rouge | Recruiting | Baton Rouge | Louisiana | 70809 | United States |
| Velocity Clinical Research - Lafayette | Recruiting | Lafayette | Louisiana | 70508 | United States |
| Velocity Clinical Research - Rockville | Recruiting | Rockville | Maryland | 20854 | United States |
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| Brooklyn Clinical Research | Recruiting | Brooklyn | New York | 11226 | United States |
| Velocity Clinical Research - Syracuse | Recruiting | East Syracuse | New York | 13057 | United States |
| Mid Hudson Medical Research, PLLC | Recruiting | New Windsor | New York | 12553 | United States |
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| Velocity Clinical Research - Cincinnati - Blue Ash | Recruiting | Cincinnati | Ohio | 45242 | United States |
| Lynn Institute of Norman | Recruiting | Norman | Oklahoma | 73072 | United States |
| Velocity Clinical Research - Medford | Recruiting | Medford | Oregon | 97504 | United States |
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| Clinical Trials of Texas, LLC | Recruiting | San Antonio | Texas | 78229 | United States |
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| Velocity Clinical Research - Spokane | Recruiting | Spokane | Washington | 99218 | United States |