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Active, not recruiting Phase 3

Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)

NCT06696443 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2024-12-18
Last updated
2026-10-19

Condition(s) studied

Diabetic Peripheral Neuropathic Pain

Investigational drug(s) / intervention(s)

Suzetrigine →

Suzetrigine: Tablets for oral administration.

Study summary

The purpose of this study is to evaluate the long-term safety and tolerability of SUZ and long-term effectiveness of SUZ in treating pain associated with DPN.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Key Inclusion Criteria: • Completed the final visit in the Treatment Period (i.e., Week 12) and subsequent 7-day period (to allow for taper of blinded capsule study drug) in a parent study such as VX24-548-110 or VX24-548-111 Key Exclusion Criteria: * Any sensory abnormality (excluding DPN) * History of drug intolerance in a parent study that would pose an additional risk to the participant in the opinion of the investigator * Current participation in an investigational drug trial (other than a parent study) Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

  • Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — From Baseline up to Week 54

Trial sites (65)

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

+ 25 more sites — see the full list on the official registry below.

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 NCT06696443 on ClinicalTrials.gov ↗ ← All trials in the USA