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

RecruitingPhase 3Ages 18 Years - 80 YearsAllVertex Pharmaceuticals Incorporated
NCT07231419 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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 within 30 days of study drug dosing * Any sensory abnormality (excluding DPN) as pre-specified in the protocol Other protocol defined Inclusion/Exclusion criteria may apply.
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What it tests

  • Suzetrigine
  • Placebo (matched to SUZ)
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Where

75 sites
Central Research Associates, LLC
Birmingham, United States
Accel Research - Birmingham
Birmingham, United States
AMR Mobile
Mobile, United States
Sun City Clinical Research
Glendale, United States
Scottsdale Clinical Trials
Scottsdale, United States
Lynn Institute of the Ozarks
Little Rock, United States
Hope Clinical Research
Canoga Park, United States
Marvel Clinical Research
Huntington Beach, United States

…and 67 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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