A Phase 3, Randomized, Double-blind, Placebo- and Active-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 (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).

Eligibility

Age range: 18–80 years
Sex: All
Healthy volunteers: No

Detailed 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 * Any sensory abnormality (excluding DPN) a…

Interventions

Drug
Suzetrigine
Tablets for oral administration.
Drug
Placebo (matched to SUZ)
Placebo matched to SUZ for oral administration.
Drug
Pregabalin
Capsules for oral administration.
Drug
Placebo (matched to Pregabalin)
Placebo matched to Pregabalin for oral administration.

Locations (76)

Pinnacle Research Group, LLC
Anniston, Alabama
Synexus Clinical Research - Birmingham
Birmingham, Alabama
AMR Daphne, AL
Daphne, Alabama
Synexus Clinical Research - Phoenix Central
Phoenix, Arizona
Scottsdale Clinical Trials
Scottsdale, Arizona
Neuro-Pain Medical Center
Fresno, California