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Active Not Recruiting
NCT06696443
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Conditions: Diabetic Peripheral Neuropathic Pain
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 455
Sponsor: Vertex Pharmaceuticals Incorporated
Location: Pinnacle Research Group, LLC Anniston Alabama
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 Criteria
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.
Source: ClinicalTrials.gov (NCT06696443). StuddyBuddy aggregates publicly available trial information.
