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

Phase 3Active Not RecruitingNCT06696443

Vertex Pharmaceuticals Incorporated455 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

455

Conditions

Diabetic Peripheral Neuropathic Pain

Interventions

SuzetrigineDRUG

Tablets for oral administration.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (65)

Outcomes

Primary Outcomes

Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: From Baseline up to Week 54

Secondary Outcomes

Change From Baseline in Study 36-item Short-form Health Status (SF-36v2) Physical Component Summary (PCS) Score

Time frame: From Baseline up to Week 52

Change From Baseline in the Short form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score

Time frame: From Baseline up to Week 52

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Pinnacle Research Group, LLC

Anniston, Alabama, United States

AMR Daphne, AL

Daphne, Alabama, United States

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

Neuro-Pain Medical Center

Fresno, California, United States

Long Beach Research Institute

Long Beach, California, United States

Angel City Research, Inc

Los Angeles, California, United States

Empire Clinical Research

Pomona, California, United States

Clinical Trials Research

Sacramento, California, United States

Velocity Clinical Research, San Bernardino

San Bernardino, California, United States

SCLA Management - Pain Management and Injury Relief

Thousand Oaks, California, United States

...and 55 more locations