Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
- Registration Number
- NCT06696443
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief 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.
- Detailed Description
A Phase 3, Open-label Study Evaluating the Long-term Safety and Effectiveness of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 300
• 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Suzetrigine (SUZ) Suzetrigine Participants will receive SUZ once daily (qd) up to 52 weeks.
- Primary Outcome Measures
Name Time Method Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Baseline up to Week 54
- Secondary Outcome Measures
Name Time Method Change From Baseline in Study 36-item Short-form Health Status (SF-36v2) Physical Component Summary (PCS) Score From Baseline up to Week 52 Change From Baseline in the Short form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score From Baseline up to Week 52
Trial Locations
- Locations (61)
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
Pain Management and Injury Relief
🇺🇸Thousand Oaks, California, United States
Scroll for more (51 remaining)Pinnacle Research Group, LLC🇺🇸Anniston, Alabama, United States