Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy
Launched by VERTEX PHARMACEUTICALS INCORPORATED · Oct 3, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called Suzetrigine (SUZ) to see how well it works for relieving pain caused by diabetic peripheral neuropathy (DPN), a condition that affects people with diabetes and can lead to pain in the legs and feet. The trial aims to find out not only if Suzetrigine helps with this pain but also if it is safe to use and how well people tolerate it.
To be eligible for this trial, participants need to be between 18 and 75 years old, weigh at least 45 kilograms, and have a diagnosis of diabetes (either type 1 or type 2). They should also experience consistent pain in both legs and have a specific level of pain measured on a scale. Participants will be asked to keep track of their pain scores during the study. If you decide to join, you can expect regular check-ins and support from the research team throughout the trial. This study is currently recruiting, and it’s a great opportunity to contribute to research that may help others with similar pain.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Body weight greater than or equal to (≥) 45 kilogram (kg)
- • Body mass index (BMI) ≥18.0 to less than (\<) 40.0 kilogram per meter square (kg/m\^2)
- • Diagnosis of diabetes mellitus type 1 or type 2 by glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN
- • Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period
- Key Exclusion Criteria:
- • More than 3 missing daily NPRS scores during the 7-day Baseline Period
- • Participation in a previous study in which the participant received SUZ
- • Any sensory abnormality (excluding DPN) as pre-specified in the protocol
- • Other protocol defined Inclusion/Exclusion criteria may apply.
About Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated is a global biotechnology company dedicated to the innovation and development of transformative therapies for serious diseases, particularly those with significant unmet medical needs. Founded in 1989 and headquartered in Boston, Massachusetts, Vertex specializes in the research and commercialization of treatments for cystic fibrosis and other genetic disorders. Leveraging cutting-edge science and a commitment to patient-centric solutions, Vertex collaborates with healthcare professionals and researchers to advance clinical trials and bring groundbreaking therapies to market, aiming to improve the lives of patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Albany, New York, United States
Walnut Creek, California, United States
Winston Salem, North Carolina, United States
Media, Pennsylvania, United States
Fresno, California, United States
Anniston, Alabama, United States
Jacksonville, Florida, United States
Boston, Massachusetts, United States
Hazelwood, Missouri, United States
Richmond, Virginia, United States
Sacramento, California, United States
Dayton, Ohio, United States
East Syracuse, New York, United States
Kansas City, Missouri, United States
Flossmoor, Illinois, United States
Pomona, California, United States
Cincinnati, Ohio, United States
Waltham, Massachusetts, United States
Dallas, Texas, United States
Lexington, Kentucky, United States
Marlton, New Jersey, United States
Maitland, Florida, United States
Bellevue, Washington, United States
Medford, Oregon, United States
Chicago, Illinois, United States
East Greenwich, Rhode Island, United States
New York, New York, United States
Dallas, Texas, United States
West Jordan, Utah, United States
West Valley City, Utah, United States
Fort Myers, Florida, United States
Meridian, Idaho, United States
Wichita, Kansas, United States
Birmingham, Alabama, United States
Miami, Florida, United States
Saint Louis, Missouri, United States
Charleston, South Carolina, United States
New York, New York, United States
Evansville, Indiana, United States
Anderson, South Carolina, United States
Grants Pass, Oregon, United States
Hallandale Beach, Florida, United States
Albuquerque, New Mexico, United States
Coral Gables, Florida, United States
Morehead City, North Carolina, United States
Scottsdale, Arizona, United States
Long Beach, California, United States
Round Rock, Texas, United States
Thousand Oaks, California, United States
Spartanburg, South Carolina, United States
San Antonio, Texas, United States
Waco, Texas, United States
Baton Rouge, Louisiana, United States
San Bernardino, California, United States
Charleston, South Carolina, United States
Norfolk, Nebraska, United States
Beachwood, Ohio, United States
Decatur, Georgia, United States
Washington, District Of Columbia, United States
Miami Lakes, Florida, United States
Daphne, Alabama, United States
Phoenix, Arizona, United States
Los Angeles, California, United States
Deland, Florida, United States
Largo, Florida, United States
New Port Richey, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Winter Park, Florida, United States
Covington, Louisiana, United States
Las Vegas, Nevada, United States
Raleigh, North Carolina, United States
Nashville, Tennessee, United States
San Bernardino, California, United States
Englewood, Colorado, United States
Miami, Florida, United States
Brooklyn, New York, United States
Raleigh, North Carolina, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported