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

Description

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).

Conditions

Diabetic Peripheral Neuropathic Pain

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Study Overview

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Study Details

Study overview

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).

A Phase 3, Randomized, Double-blind, Placebo- and Active-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy

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

Condition
Diabetic Peripheral Neuropathic Pain
Intervention / Treatment

-

Contacts and Locations

Daphne

AMR Daphne, AL, Daphne, Alabama, United States, 36526

Long Beach

Long Beach Research Institute, Long Beach, California, United States, 90805

Sacramento

Clinical Trials Research, Sacramento, California, United States, 95821

San Bernardino

Velocity Clinical Research - Banning, San Bernardino, California, United States, 92408

Washington

Velocity Clinical Research - Washington DC, Washington, District of Columbia, United States, 20016

Fort Myers

AMR Fort Myers (The Clinical Study Center), Fort Myers, Florida, United States, 33912

Hallandale Beach

Velocity Clinical Research - Hallandale Beach, Hallandale Beach, Florida, United States, 33009

Maitland

Accel Research Sites - Maitland, Maitland, Florida, United States, 32751

Miami Lakes

3Sync Research - Miami Lakes, Miami Lakes, Florida, United States, 33014

Decatur

ARSN - NeuroStudies, Decatur, Georgia, United States, 30030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * More than 3 missing daily NPRS scores during the 7-day Baseline Period
  • * Participation in a previous study in which the participant received SUZ
  • * Any sensory abnormality (excluding DPN) as pre-specified in the protocol

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vertex Pharmaceuticals Incorporated,

Study Record Dates

2027-05