ConditionDiabetic Peripheral Neuropathic Pain
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 groupsSponsors and collaborators
Source ClinicalTrials.gov