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The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) 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. |
|
| Pregabalin | Active Comparator | Participants will be randomized to receive Pregabalin. |
|
| Placebo | Placebo Comparator | Participants will be randomized to receive placebo matched to SUZ and Pregabalin. |
|
| 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 VX24-548-111) | From Baseline up to Week 12 | |
| Change From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12 Compared to Pregabalin |
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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 | 617-341-6777 | medicalinfo@vrtx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Recruiting | Anniston | Alabama | 36207 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42249666 | Derived | Fensterwald M, Johnson J, Moreno A, Conger-Love S, Flippen C, Hesterman C, Johnston M, Kamins J, Minota K, Pak P, Hashim S, Huynh-Tran TL, Kobayashi N, Shane B, Charles A, Nwaobi S. Suzetrigine as a novel treatment for headache disorders: A case series. Headache. 2026 Jul-Aug;66(7):1644-1649. doi: 10.1111/head.70147. Epub 2026 Jun 5. |
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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. |
|
| Pregabalin | Drug | Capsules for oral administration. |
|
| Placebo (matched to Pregabalin) | Drug | Placebo matched to Pregabalin for oral administration. |
|
| From Baseline up to Week 12 |
| Synexus Clinical Research - Birmingham |
| Completed |
| Birmingham |
| Alabama |
| 35211 |
| United States |
| AMR Daphne, AL | Completed | Daphne | Alabama | 36526 | United States |
| Synexus Clinical Research - Phoenix Central | Completed | Phoenix | Arizona | 85020 | United States |
| Scottsdale Clinical Trials | Recruiting | Scottsdale | Arizona | 85260 | United States |
| Neuro-Pain Medical Center | Recruiting | Fresno | California | 93710 | United States |
| Long Beach Research Institute | Recruiting | Long Beach | California | 90805 | United States |
| Angel City Research, Inc | Recruiting | Los Angeles | California | 90010 | United States |
| Empire Clinical Research | Recruiting | Pomona | California | 91767 | United States |
| Clinical Trials Research | Recruiting | Sacramento | California | 95821 | United States |
| Velocity Clinical Research, San Bernardino | Recruiting | San Bernardino | California | 92408 | United States |
| SCLA Management - Pain Management and Injury Relief | Recruiting | Thousand Oaks | California | 91320 | United States |
| Diablo Clinical Research (DCR) | Completed | Walnut Creek | California | 94598 | United States |
| Velocity Clinical Research - Denver | Recruiting | Englewood | Colorado | 80110 | United States |
| Velocity Clinical Research - Washington DC | Recruiting | Washington D.C. | District of Columbia | 20016 | United States |
| Accel Research - Deland | Recruiting | DeLand | Florida | 32720 | United States |
| AMR-Miami | Recruiting | Doral | Florida | 33172 | United States |
| AMR Fort Myers (The Clinical Study Center) | Recruiting | Fort Myers | Florida | 33912 | United States |
| Velocity Clinical Research - Hallandale Beach | Recruiting | Hallandale | Florida | 33009 | United States |
| CNS Healthcare - Jacksonville | Recruiting | Jacksonville | Florida | 32256 | United States |
| Accel Research - St. Petersburg-Largo | Recruiting | Largo | Florida | 33777 | United States |
| Accel Research - Maitland | Completed | Maitland | Florida | 32751 | United States |
| Suncoast Research Associates - Miami | Recruiting | Miami | Florida | 33172 | United States |
| 3Sync Research - Miami Lakes | Recruiting | Miami Lakes | Florida | 33014 | United States |
| Suncoast Clinical Research - New Port Richey | Recruiting | New Port Richey | Florida | 34652 | United States |
| Synexus Clinical Research - Orlando | Completed | Orlando | Florida | 32806 | United States |
| Conquest Clinical Research - Orlando - Neuro | Recruiting | Orlando | Florida | 32832 | United States |
| Conquest Clinical Research - Winter Park | Recruiting | Winter Park | Florida | 32789 | United States |
| Accel Research - Decatur | Recruiting | Decatur | Georgia | 30030 | United States |
| Velocity Clinical Research - Boise | Recruiting | Meridian | Idaho | 83642 | United States |
| Feinberg School of Medicine - Anesthesiology | Recruiting | Chicago | Illinois | 60611 | United States |
| Healthcare Research Network - Flossmoor IL | Recruiting | Flossmoor | Illinois | 604773027 | United States |
| Synexus Clinical Research - Evansville | Completed | Evansville | Indiana | 47714 | United States |
| AMR Wichita East, KS (Heartland Research Associates) | Recruiting | Wichita | Kansas | 67207 | United States |
| AMR Lexington | Recruiting | Lexington | Kentucky | 40509 | United States |
| Velocity Clinical Research - Baton Rouge | Recruiting | Baton Rouge | Louisiana | 70809 | United States |
| Tandem Clinical Research- Covington | Recruiting | Covington | Louisiana | 70433 | United States |
| Mass General Brigham - Brigham and Women's Hospital - Main Campus | Recruiting | Boston | Massachusetts | 02115 | United States |
| MedVadis Research Corporation | Recruiting | Waltham | Massachusetts | 02451 | United States |
| Healthcare Research Network - Hazelwood MO | Recruiting | Hazelwood | Missouri | 63042 | United States |
| AMR Kansas City | Recruiting | Kansas City | Missouri | 64114 | United States |
| St. Louis Children's Hospital - Nephrology | Recruiting | St Louis | Missouri | 63110 | United States |
| Synexus Clinical Research - St. Louis | Completed | St Louis | Missouri | 63141 | United States |
| Velocity Clinical Research - Norfolk | Recruiting | Norfolk | Nebraska | 68701 | United States |
| Synexus Clinical Research - Las Vegas | Completed | Las Vegas | Nevada | 89113 | United States |
| HRI - Hassman Research Institute | Completed | Marlton | New Jersey | 08053 | United States |
| Velocity Clinical Research - Albuquerque | Recruiting | Albuquerque | New Mexico | 87107 | United States |
| Albany Medical College | Completed | Albany | New York | 12208 | United States |
| Swift Clinical OpCo, Inc | Recruiting | Brooklyn | New York | 11226 | United States |
| Velocity Clinical Research - Syracuse | Recruiting | East Syracuse | New York | 13057 | United States |
| Synexus Clinical Research - New York (DRS) | Completed | New York | New York | 10017 | United States |
| Columbia Presbyterian - The Neurological Institute of New York | Recruiting | New York | New York | 10032 | United States |
| West Clinical Research | Recruiting | Morehead City | North Carolina | 28557 | United States |
| Eximia Research - Raleigh | Recruiting | Raleigh | North Carolina | 27607 | United States |
| Carolinas Pain Institute - Winston-Salem Office | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
| Velocity Clinical Research - Cleveland | Recruiting | Beachwood | Ohio | 44122 | United States |
| Synexus Clinical Research - Cincinnati | Completed | Cincinnati | Ohio | 45236 | United States |
| META Medical Research Institute | Recruiting | Dayton | Ohio | 45432 | United States |
| Velocity Clinical Research - Grants Pass | Completed | Grants Pass | Oregon | 97527 | United States |
| Velocity Clinical Research - Medford | Recruiting | Medford | Oregon | 97504 | United States |
| Suburban Research Associates - Media | Recruiting | Media | Pennsylvania | 19063 | United States |
| Velocity Clinical Research - Providence | Recruiting | East Greenwich | Rhode Island | 02818 | United States |
| Synexus Clinical Research- Anderson | Completed | Anderson | South Carolina | 29621 | United States |
| Clinical Trials of South Carolina - Berkeley - Charleston | Recruiting | Charleston | South Carolina | 29406 | United States |
| M3 Wake Research - Charleston | Recruiting | Charleston | South Carolina | 29414 | United States |
| Velocity Clinical Research - Spartanburg | Recruiting | Spartanburg | South Carolina | 29303 | United States |
| AMR Nashville, TN | Completed | Nashville | Tennessee | 37203 | United States |
| Zenos Clinical Research | Recruiting | Dallas | Texas | 75230 | United States |
| Synexus Clinical Research - Dallas (DFW) (DRS) | Completed | Dallas | Texas | 75234 | United States |
| Be Well Clinical Studies - Austin | Recruiting | Round Rock | Texas | 78681 | United States |
| San Antonio Clinical Trials | Recruiting | San Antonio | Texas | 78240 | United States |
| Velocity Clinical Research - Waco | Recruiting | Waco | Texas | 76710 | United States |
| Velocity Clinical Research - Salt Lake City | Recruiting | West Jordan | Utah | 84088 | United States |
| Kalo Clinical Research - West Valley City | Recruiting | West Valley City | Utah | 84120 | United States |
| Dominion Medical Associates, Inc. | Recruiting | Richmond | Virginia | 23219 | United States |
| Northwest Clinical Research Center (NWCRC) | Recruiting | Bellevue | Washington | 98007 | United States |
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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