A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
Vertex Pharmaceuticals Incorporated
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine in participants with pain associated with diabetic peripheral neuropathy (DPN).
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Body weight greater than or equal to (≥)45 kilogram (kg) * Body mass index (BMI) ≥18 to less than (\<) 40 kilogram per meter square (kg/m\^2) * Diagnosis of diabetes mellitus type 1 or type 2 and with glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN for at least 1 year * 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 * Received Journavx wi…
Interventions
- DrugSuzetrigine
Tablets for oral administration
- DrugPlacebo (matched to SUZ)
Placebo matched to SUZ for oral administration.
Locations (65)
- Central Research Associates, LLCBirmingham, Alabama
- Accel Research - BirminghamBirmingham, Alabama
- AMR MobileMobile, Alabama
- Scottsdale Clinical TrialsScottsdale, Arizona
- Hope Clinical ResearchCanoga Park, California
- Marvel Clinical ResearchHuntington Beach, California