Actively Recruiting
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Suzetrigine Tablets for Pain Associated With Diabetic Peripheral Neuropathy
Led by Vertex Pharmaceuticals Incorporated · Updated on 2026-05-19
734
Participants Needed
75
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness, safety, and tolerability of Suzetrigine in adults experiencing pain caused by diabetic peripheral neuropathy (DPN). This phase 3 clinical trial focuses on participants with diabetes type 1 or type 2 who have had bilateral lower extremity pain for at least one year, aiming to understand how Suzetrigine impacts pain levels compared to placebo. Participants will be randomly assigned to receive either Suzetrigine tablets or a placebo that looks like Suzetrigine. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. Treatments are taken orally, and the main treatment period lasts 12 weeks. During the study, participants will regularly report their daily pain intensity using the Numeric Pain Rating Scale (NPRS). Researchers will also assess physical health using the SF-36v2 questionnaire. Safety and tolerability will be closely monitored throughout. The total participation duration covers screening, treatment, and follow-up until the study ends in April 2027.
CONDITIONS
Brief Title
Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body weight greater than or equal to 45 kilograms
- Body mass index (BMI) between 18 and less than 40 kg/m²
- Diagnosis of type 1 or type 2 diabetes with HbA1c 9% or higher
- Presence of bilateral pain in lower extremities due to diabetic peripheral neuropathy for at least 1 year
- Weekly average daily pain score between 4 and 9 with limited variation during a 7-day baseline period
You will not qualify if you...
- More than 3 missing daily pain scores during the 7-day baseline period
- Use of Journavx within 30 days before starting study drug
- Any sensory abnormality other than diabetic peripheral neuropathy as defined in the study protocol
- Other inclusion or exclusion criteria as specified in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive Suzetrigine or placebo tablets to manage pain associated with diabetic peripheral neuropathy.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 75 locations
1
Central Research Associates, LLC
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
Accel Research - Birmingham
Birmingham, Alabama, United States, 35216
Actively Recruiting
3
AMR Mobile
Mobile, Alabama, United States, 36608
Actively Recruiting
4
Sun City Clinical Research
Glendale, Arizona, United States, 85304
Actively Recruiting
5
Scottsdale Clinical Trials
Scottsdale, Arizona, United States, 85260
Actively Recruiting
6
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States, 72204
Actively Recruiting
7
Hope Clinical Research
Canoga Park, California, United States, 91303
Actively Recruiting
8
Marvel Clinical Research
Huntington Beach, California, United States, 92647
Actively Recruiting
9
Eximia Research-CA, LLC
La Mesa, California, United States, 91942
Actively Recruiting
10
Long Beach Research Institute
Long Beach, California, United States, 90805
Actively Recruiting
11
Paradigm Clincial Research - Modesto
Modesto, California, United States, 95355
Actively Recruiting
12
Pasadena Clinical Trials
Pasadena, California, United States, 91101
Actively Recruiting
13
Artemis Institute for Clinical Research - Riverside
Riverside, California, United States, 92503
Actively Recruiting
14
Velocity Clinical Research -San Bernardino
San Bernardino, California, United States, 92408
Actively Recruiting
15
Alpine Clinical Research Center
Boulder, Colorado, United States, 80301
Actively Recruiting
16
Paradigm Clinical Research - Wheat Ridge
Wheat Ridge, Colorado, United States, 80033
Actively Recruiting
17
Chase Medical Research
Waterbury, Connecticut, United States, 06708
Actively Recruiting
18
Velocity Clinical Research - Washington DC
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
19
Neurology Offices of South Florida, PLLC
Boca Raton, Florida, United States, 33428
Actively Recruiting
20
Accel Research - Deland
DeLand, Florida, United States, 32720
Actively Recruiting
21
Velocity Clinical Research - Hallandale Beach
Hallandale, Florida, United States, 33009
Actively Recruiting
22
CNS Healthcare - Jacksonville
Jacksonville, Florida, United States, 32256
Actively Recruiting
23
Health Awareness, Inc. - Jupiter
Jupiter, Florida, United States, 33458
Actively Recruiting
24
3Sync Research -Miami Lakes
Miami Lakes, Florida, United States, 33014
Actively Recruiting
25
Aqualane Clinical Research
Naples, Florida, United States, 34105
Actively Recruiting
26
CNS Healthcare - Orlando
Orlando, Florida, United States, 32806
Actively Recruiting
27
Suncoast Clinical Research - Palm Harbor
Palm Harbor, Florida, United States, 34684
Actively Recruiting
28
3Sync Research - Palm Springs
Palm Springs, Florida, United States, 33461
Actively Recruiting
29
Health Awareness, Inc. - Port St. Lucie
Port Saint Lucie, Florida, United States, 34952
Actively Recruiting
30
ClinCloud - Viera
Viera, Florida, United States, 32940
Actively Recruiting
31
Conquest Clinical Research - Winter Park
Winter Park, Florida, United States, 32789
Actively Recruiting
32
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
Actively Recruiting
33
Accel Research - Decatur
Decatur, Georgia, United States, 30030
Actively Recruiting
34
Javara Inc./Privia Medical Group - Fayetteville, GA
Fayetteville, Georgia, United States, 30214
Actively Recruiting
35
Velocity Clinical Research - Savannah
Savannah, Georgia, United States, 31406
Actively Recruiting
36
Healthcare Research Network - Flossmoor IL
Tinley Park, Illinois, United States, 60477
Actively Recruiting
37
Velocity Clinical Research - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
Actively Recruiting
38
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, United States, 70508
Actively Recruiting
39
Velocity Clinical Research - Rockville
Rockville, Maryland, United States, 20854
Actively Recruiting
40
Boston Clinical Trials
Boston, Massachusetts, United States, 02131
Actively Recruiting
41
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
42
Velocity Clinical Research - Gulfport
Gulfport, Mississippi, United States, 39503
Actively Recruiting
43
SCLA Management - St. Louis Pain Consultants
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
44
Healthcare Research Network - Hazelwood MO
Hazelwood, Missouri, United States, 63042
Actively Recruiting
45
AMR Kansas City
Kansas City, Missouri, United States, 64114
Actively Recruiting
46
M3 Wake Research - Las Vegas
Las Vegas, Nevada, United States, 89106
Actively Recruiting
47
CenExel AMRI
Toms River, New Jersey, United States, 08755
Actively Recruiting
48
Brooklyn Clinical Research
Brooklyn, New York, United States, 11226
Actively Recruiting
49
Velocity Clinical Research - Syracuse
East Syracuse, New York, United States, 13057
Actively Recruiting
50
Mid Hudson Medical Research, PLLC
New Windsor, New York, United States, 12553
Actively Recruiting
51
Rochester Clinical Research - Rochester
Rochester, New York, United States, 14609
Actively Recruiting
52
Asheville Clinical Research
Asheville, North Carolina, United States, 28803
Actively Recruiting
53
Monroe Biomedical research
Monroe, North Carolina, United States, 28112
Actively Recruiting
54
West Clinical Research
Morehead City, North Carolina, United States, 28557
Actively Recruiting
55
Velocity Clinical Research - Cleveland
Beachwood, Ohio, United States, 44122
Actively Recruiting
56
Velocity Clinical Research - Cincinnati - Blue Ash
Cincinnati, Ohio, United States, 45242
Actively Recruiting
57
Lynn Institute of Norman
Norman, Oklahoma, United States, 73072
Actively Recruiting
58
Velocity Clinical Research - Medford
Medford, Oregon, United States, 97504
Actively Recruiting
59
Velocity Clinical Research - Providence
East Greenwich, Rhode Island, United States, 02818
Actively Recruiting
60
Velocity Clinical Research - Anderson
Anderson, South Carolina, United States, 29621
Actively Recruiting
61
Coastal Carolina Research Center
North Charleston, South Carolina, United States, 29405
Actively Recruiting
62
Velocity Clinical Research - Spartanburg
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
63
M3 Wake Research - Chattanooga
Chattanooga, Tennessee, United States, 37421
Actively Recruiting
64
Holston Medical Group
Kingsport, Tennessee, United States, 37660
Actively Recruiting
65
AMR Knoxville, TN
Knoxville, Tennessee, United States, 37909
Actively Recruiting
66
CNS Healthcare - Memphis
Memphis, Tennessee, United States, 38119
Actively Recruiting
67
Amarillo Medical Specialists LLP
Amarillo, Texas, United States, 79124
Actively Recruiting
68
QCR - BioBehavioral Research of Austin
Austin, Texas, United States, 78759
Actively Recruiting
69
Zenos Clinical Research
Dallas, Texas, United States, 75230
Actively Recruiting
70
Fort Worth Endocrine Research Center
Fort Worth, Texas, United States, 76132
Actively Recruiting
71
Epic Clinical Research
Lewisville, Texas, United States, 75057
Actively Recruiting
72
Prime Clinical Research - Mansfield - US 287
Mansfield, Texas, United States, 76063
Actively Recruiting
73
Clinical Trials of Texas, LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
74
AMR Norfolk
Norfolk, Virginia, United States, 23502
Actively Recruiting
75
Velocity Clinical Research - Spokane
Spokane, Washington, United States, 99218
Actively Recruiting
Research Team
M
Medical Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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