Suzetrigine for Diabetic Neuropathy
Recruiting at 40 trial locations
MI
Overseen ByMedical Information
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Vertex Pharmaceuticals Incorporated
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
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
This trial is for individuals who have completed a previous study on Suzetrigine and are experiencing painful diabetic peripheral neuropathy. They must not have other sensory abnormalities, history of drug intolerance that poses risks, or be currently in another investigational drug trial.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
Exclusion Criteria
I have a sensory issue not related to diabetic peripheral neuropathy.
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)
Treatment Details
Interventions
- Suzetrigine (Sodium Channel Blocker)
Trial OverviewThe study is testing the long-term safety and effectiveness of a medication called Suzetrigine (SUZ) for treating pain associated with diabetic peripheral neuropathy over an extended period following initial treatment.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Suzetrigine (SUZ)Experimental Treatment1 Intervention
Participants will receive SUZ once daily (qd) up to 52 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vertex Pharmaceuticals Incorporated
Lead Sponsor
Trials
267
Recruited
36,100+
Dr. David Altshuler
Vertex Pharmaceuticals Incorporated
Chief Medical Officer since 2020
MD, PhD
Dr. Reshma Kewalramani
Vertex Pharmaceuticals Incorporated
Chief Executive Officer since 2020
MD, trained in internal medicine and nephrology