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

NCT06628908

RecruitingPhase 3

Sponsor: Vertex Pharmaceuticals Incorporated

Conditions: Diabetic Peripheral Neuropathic Pain

Interventions: Suzetrigine, Placebo (matched to SUZ), Pregabalin, Placebo (matched to Pregabalin)

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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) as pre-specified in the protocol

Other protocol defined Inclusion/Exclusion criteria may apply.
Locations (76)
  • Anniston, Alabama, United States
  • Birmingham, Alabama, United States
  • Daphne, Alabama, United States
  • Phoenix, Arizona, United States
  • Scottsdale, Arizona, United States
  • Fresno, California, United States
  • Long Beach, California, United States
  • Los Angeles, California, United States
  • Pomona, California, United States
  • Sacramento, California, United States
  • San Bernardino, California, United States
  • Thousand Oaks, California, United States
  • Walnut Creek, California, United States
  • Englewood, Colorado, United States
  • Washington D.C., District of Columbia, United States
  • DeLand, Florida, United States
  • Doral, Florida, United States
  • Fort Myers, Florida, United States
  • Hallandale, Florida, United States
  • Jacksonville, Florida, United States
  • Largo, Florida, United States
  • Maitland, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • New Port Richey, Florida, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • Winter Park, Florida, United States
  • Decatur, Georgia, United States
  • Meridian, Idaho, United States
  • + 46 more on CT.gov