Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVertex Pharmaceuticals Incorporated

About this trial

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 criteria

Qualifiers

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/m²)

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

Disqualifiers

More than 3 missing daily NPRS scores during the 7-day Baseline Period

Any sensory abnormality (excluding DPN) as pre-specified in the protocol

Trial design

Treatments tested in this trial

  • Suzetrigine
  • Placebo (matched to SUZ)
  • Pregabalin
  • Placebo (matched to Pregabalin)

Treatment groups

1,100 Participants
are divided into 3 treatment groups