Diabetic Peripheral Neuropathic PainPhase 3NCT06628908
Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy
A Phase 3 study testing Suzetrigine and Pregabalin in people with Diabetic Peripheral Neuropathic Pain, run by Vertex Pharmaceuticals Incorporated at 76 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain
- What is being tested?
- Suzetrigine and Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,100 participants
- Where
- 76 sitesUnited States
- Study dates
- 1 Oct 2024to 31 May 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body weight greater than or equal to (≥) 45 kilogram (kg)
- Body mass index (BMI) ≥18.0 to less than (<) 40.0 kilogram per meter square (kg/m^2)
- Diagnosis of diabetes mellitus type 1 or type 2 by glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN
- Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period
Who cannot join
- More than 3 missing daily NPRS scores during the 7-day Baseline Period
- Any sensory abnormality (excluding DPN) as pre-specified in the protocol
- Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
76 sites in 1 country. Contact the study team or a site near you to ask about taking part.
76 sites in 1 country
United States76 sites, 58 recruiting
- Completed
Albany Medical College
Albany, New York, 12208
- Recruiting
Velocity Clinical Research - Albuquerque
Albuquerque, New Mexico, 87107
- Completed
Synexus Clinical Research- Anderson
Anderson, South Carolina, 29621
- Recruiting
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
- Recruiting
Velocity Clinical Research - Baton Rouge
Baton Rouge, Louisiana, 70809
- Recruiting
Velocity Clinical Research - Cleveland
Beachwood, Ohio, 44122
- Recruiting
Northwest Clinical Research Center (NWCRC)
Bellevue, Washington, 98007
- Completed
Synexus Clinical Research - Birmingham
Birmingham, Alabama, 35211
- Recruiting
Mass General Brigham - Brigham and Women's Hospital - Main Campus
Boston, Massachusetts, 02115
- Recruiting
Swift Clinical OpCo, Inc
Brooklyn, New York, 11226
- Recruiting
Clinical Trials of South Carolina - Berkeley - Charleston
Charleston, South Carolina, 29406
- Recruiting
M3 Wake Research - Charleston
Charleston, South Carolina, 29414
- Recruiting
Feinberg School of Medicine - Anesthesiology
Chicago, Illinois, 60611
- Completed
Synexus Clinical Research - Cincinnati
Cincinnati, Ohio, 45236
- Recruiting
Tandem Clinical Research- Covington
Covington, Louisiana, 70433
- Recruiting
Zenos Clinical Research
Dallas, Texas, 75230
- Completed
Synexus Clinical Research - Dallas (DFW) (DRS)
Dallas, Texas, 75234
- Completed
AMR Daphne, AL
Daphne, Alabama, 36526
- Recruiting
META Medical Research Institute
Dayton, Ohio, 45432
- Recruiting
Accel Research - Decatur
Decatur, Georgia, 30030
- Recruiting
Accel Research - Deland
DeLand, Florida, 32720
- Recruiting
AMR-Miami
Doral, Florida, 33172
- Recruiting
Velocity Clinical Research - Providence
East Greenwich, Rhode Island, 02818
- Recruiting
Velocity Clinical Research - Syracuse
East Syracuse, New York, 13057
- Recruiting
Velocity Clinical Research - Denver
Englewood, Colorado, 80110
- Completed
Synexus Clinical Research - Evansville
Evansville, Indiana, 47714
- Recruiting
Healthcare Research Network - Flossmoor IL
Flossmoor, Illinois, 604773027
- Recruiting
AMR Fort Myers (The Clinical Study Center)
Fort Myers, Florida, 33912
- Recruiting
Neuro-Pain Medical Center
Fresno, California, 93710
- Completed
Velocity Clinical Research - Grants Pass
Grants Pass, Oregon, 97527
- Recruiting
Velocity Clinical Research - Hallandale Beach
Hallandale, Florida, 33009
- Recruiting
Healthcare Research Network - Hazelwood MO
Hazelwood, Missouri, 63042
- Recruiting
CNS Healthcare - Jacksonville
Jacksonville, Florida, 32256
- Recruiting
AMR Kansas City
Kansas City, Missouri, 64114
- Recruiting
Accel Research - St. Petersburg-Largo
Largo, Florida, 33777
- Completed
Synexus Clinical Research - Las Vegas
Las Vegas, Nevada, 89113
- Recruiting
AMR Lexington
Lexington, Kentucky, 40509
- Recruiting
Long Beach Research Institute
Long Beach, California, 90805
- Recruiting
Angel City Research, Inc
Los Angeles, California, 90010
- Completed
Accel Research - Maitland
Maitland, Florida, 32751
- Completed
HRI - Hassman Research Institute
Marlton, New Jersey, 08053
- Recruiting
Velocity Clinical Research - Medford
Medford, Oregon, 97504
- Recruiting
Suburban Research Associates - Media
Media, Pennsylvania, 19063
- Recruiting
Velocity Clinical Research - Boise
Meridian, Idaho, 83642
- Recruiting
Suncoast Research Associates - Miami
Miami, Florida, 33172
- Recruiting
3Sync Research - Miami Lakes
Miami Lakes, Florida, 33014
- Recruiting
West Clinical Research
Morehead City, North Carolina, 28557
- Completed
AMR Nashville, TN
Nashville, Tennessee, 37203
- Recruiting
Suncoast Clinical Research - New Port Richey
New Port Richey, Florida, 34652
- Completed
Synexus Clinical Research - New York (DRS)
New York, New York, 10017
- Recruiting
Columbia Presbyterian - The Neurological Institute of New York
New York, New York, 10032
- Recruiting
Velocity Clinical Research - Norfolk
Norfolk, Nebraska, 68701
- Completed
Synexus Clinical Research - Orlando
Orlando, Florida, 32806
- Recruiting
Conquest Clinical Research - Orlando - Neuro
Orlando, Florida, 32832
- Completed
Synexus Clinical Research - Phoenix Central
Phoenix, Arizona, 85020
- Recruiting
Empire Clinical Research
Pomona, California, 91767
- Recruiting
Eximia Research - Raleigh
Raleigh, North Carolina, 27607
- Recruiting
Dominion Medical Associates, Inc.
Richmond, Virginia, 23219
- Recruiting
Be Well Clinical Studies - Austin
Round Rock, Texas, 78681
- Recruiting
Clinical Trials Research
Sacramento, California, 95821
- Recruiting
San Antonio Clinical Trials
San Antonio, Texas, 78240
- Recruiting
Velocity Clinical Research, San Bernardino
San Bernardino, California, 92408
- Recruiting
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260
- Recruiting
Velocity Clinical Research - Spartanburg
Spartanburg, South Carolina, 29303
- Completed
St. Louis Children's Hospital - Nephrology
St Louis, Missouri, 63110
- Completed
Synexus Clinical Research - St. Louis
St Louis, Missouri, 63141
- Recruiting
SCLA Management - Pain Management and Injury Relief
Thousand Oaks, California, 91320
- Recruiting
Velocity Clinical Research - Waco
Waco, Texas, 76710
- Completed
Diablo Clinical Research (DCR)
Walnut Creek, California, 94598
- Recruiting
MedVadis Research Corporation
Waltham, Massachusetts, 02451
- Recruiting
Velocity Clinical Research - Washington DC
Washington D.C., District of Columbia, 20016
- Recruiting
Velocity Clinical Research - Salt Lake City
West Jordan, Utah, 84088
- Recruiting
Kalo Clinical Research - West Valley City
West Valley City, Utah, 84120
- Recruiting
AMR Wichita East, KS (Heartland Research Associates)
Wichita, Kansas, 67207
- Recruiting
Carolinas Pain Institute - Winston-Salem Office
Winston-Salem, North Carolina, 27103
- Recruiting
Conquest Clinical Research - Winter Park
Winter Park, Florida, 32789
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo- and Active-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
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).
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Being tested
- Suzetrigine, Placebo (matched to SUZ), Pregabalin, Placebo (matched to Pregabalin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuzetrigineDrug
Also called VX-548, SUZ
Tablets for oral administration.
Placebo (matched to SUZ)Drug
Placebo matched to SUZ for oral administration.
PregabalinDrug
Capsules for oral administration.
Placebo (matched to Pregabalin)Drug
Placebo matched to Pregabalin for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Suzetrigine (SUZ) | Experimental | Participants will be randomized to receive SUZ. Receives: Drug: Suzetrigine; Drug: Placebo (matched to Pregabalin) |
| Pregabalin | Active comparator | Participants will be randomized to receive Pregabalin. Receives: Drug: Placebo (matched to SUZ); Drug: Pregabalin |
| Placebo | Placebo comparator | Participants will be randomized to receive placebo matched to SUZ and Pregabalin. Receives: Drug: Placebo (matched to SUZ); Drug: Placebo (matched to Pregabalin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo
Measured: From Baseline up to Week 12
Secondary outcomes (2)
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)
Measured: 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
Measured: From Baseline up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Oct 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628908
- Sponsor's protocol ID
- VX24-548-110
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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/
Publications
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.
PubMed 42249666