Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy
Phase 3 – large-scale trial before approval
Conditions:
Diabetic Peripheral Neuropathic Pain
Sponsor: Vertex Pharmaceuticals Incorporated
trial.available_in:
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Overview
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).
Who can participate
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.
Interventions
Suzetrigine
DRUG
Placebo (matched to SUZ)
DRUG
Locations
63
United States (63)
Amarillo Medical Specialists LLP
Amarillo , Texas
Velocity Clinical Research - Anderson
Anderson , South Carolina
Asheville Clinical Research
Asheville , North Carolina
Atlanta Center for Medical Research
Atlanta , Georgia
QCR - BioBehavioral Research of Austin
Austin , Texas
Velocity Clinical Research - Baton Rouge
Baton Rouge , Louisiana
Velocity Clinical Research - Cleveland
Beachwood , Ohio
Accel Research - Birmingham
Birmingham , Alabama
Neurology Offices of South Florida, PLLC
Boca Raton , Florida
Alpine Clinical Research Center
Boulder , Colorado
Brooklyn Clinical Research
Brooklyn , New York
Hope Clinical Research
Canoga Park , California
Velocity Clinical Research - Cincinnati - Blue Ash
Cincinnati , Ohio
SCLA Management - St. Louis Pain Consultants
Creve Coeur , Missouri
Zenos Clinical Research
Dallas , Texas
Accel Research - Decatur
Decatur , Georgia
Accel Research - Deland
DeLand , Florida
Velocity Clinical Research - Providence
East Greenwich , Rhode Island
Velocity Clinical Research - Syracuse
East Syracuse , New York
Quest Research Institute
Farmington Hills , Michigan
Javara Inc./Privia Medical Group - Fayetteville, GA
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