Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy

NCT06628908 · tracked via the Priya Life Science USA tracker

Sponsor

Vertex Pharmaceuticals Incorporated

Phase

Phase 3

Started

2024-10-01

Last updated

2026-06-15

Condition(s) studied

Diabetic Peripheral Neuropathic Pain

Investigational drug(s) / intervention(s)

SuzetriginePlacebo (matched to SUZ)PregabalinPlacebo (matched to Pregabalin)

Suzetrigine: Tablets for oral administration.

Placebo (matched to SUZ): Placebo matched to SUZ for oral administration.

Pregabalin: Capsules for oral administration.

Placebo (matched to Pregabalin): Placebo matched to Pregabalin for oral administration.

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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.

Primary outcome measure(s)

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

Trial sites (76)

Facility	City	Region	Status
Pinnacle Research Group, LLC	Anniston	Alabama	Recruiting
Synexus Clinical Research - Birmingham	Birmingham	Alabama	Completed
AMR Daphne, AL	Daphne	Alabama	Completed
Synexus Clinical Research - Phoenix Central	Phoenix	Arizona	Completed
Scottsdale Clinical Trials	Scottsdale	Arizona	Recruiting
Neuro-Pain Medical Center	Fresno	California	Recruiting
Long Beach Research Institute	Long Beach	California	Recruiting
Angel City Research, Inc	Los Angeles	California	Recruiting
Empire Clinical Research	Pomona	California	Recruiting
Clinical Trials Research	Sacramento	California	Recruiting
Velocity Clinical Research, San Bernardino	San Bernardino	California	Recruiting
SCLA Management - Pain Management and Injury Relief	Thousand Oaks	California	Recruiting
Diablo Clinical Research (DCR)	Walnut Creek	California	Completed
Velocity Clinical Research - Denver	Englewood	Colorado	Recruiting
Velocity Clinical Research - Washington DC	Washington D.C.	District of Columbia	Recruiting
Accel Research - Deland	DeLand	Florida	Recruiting
AMR-Miami	Doral	Florida	Recruiting
AMR Fort Myers (The Clinical Study Center)	Fort Myers	Florida	Recruiting
Velocity Clinical Research - Hallandale Beach	Hallandale	Florida	Recruiting
CNS Healthcare - Jacksonville	Jacksonville	Florida	Recruiting
Accel Research - St. Petersburg-Largo	Largo	Florida	Recruiting
Accel Research - Maitland	Maitland	Florida	Completed
Suncoast Research Associates - Miami	Miami	Florida	Recruiting
3Sync Research - Miami Lakes	Miami Lakes	Florida	Recruiting
Suncoast Clinical Research - New Port Richey	New Port Richey	Florida	Recruiting
Synexus Clinical Research - Orlando	Orlando	Florida	Completed
Conquest Clinical Research - Orlando - Neuro	Orlando	Florida	Recruiting
Conquest Clinical Research - Winter Park	Winter Park	Florida	Recruiting
Accel Research - Decatur	Decatur	Georgia	Recruiting
Velocity Clinical Research - Boise	Meridian	Idaho	Recruiting
Feinberg School of Medicine - Anesthesiology	Chicago	Illinois	Recruiting
Healthcare Research Network - Flossmoor IL	Flossmoor	Illinois	Recruiting
Synexus Clinical Research - Evansville	Evansville	Indiana	Completed
AMR Wichita East, KS (Heartland Research Associates)	Wichita	Kansas	Recruiting
AMR Lexington	Lexington	Kentucky	Recruiting
Velocity Clinical Research - Baton Rouge	Baton Rouge	Louisiana	Recruiting
Tandem Clinical Research- Covington	Covington	Louisiana	Recruiting
Mass General Brigham - Brigham and Women's Hospital - Main Campus	Boston	Massachusetts	Recruiting
MedVadis Research Corporation	Waltham	Massachusetts	Recruiting
Healthcare Research Network - Hazelwood MO	Hazelwood	Missouri	Recruiting

+ 36 more sites — see the full list on the official registry below.

On this site

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Other trials for the same condition

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MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP Recruiting

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Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy Recruiting

Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06628908 on ClinicalTrials.gov ↗ ← All trials in the USA