RECRUITING

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

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Conditions

Diabetic Peripheral Neuropathic Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-10-01
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06628908

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Body weight greater than or equal to (≥) 45 kilogram (kg)
  2. * Body mass index (BMI) ≥18.0 to less than (\<) 40.0 kilogram per meter square (kg/m\^2)
  3. * 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
  4. * Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period
  1. * More than 3 missing daily NPRS scores during the 7-day Baseline Period
  2. * Participation in a previous study in which the participant received SUZ
  3. * Any sensory abnormality (excluding DPN) as pre-specified in the protocol

Contacts and Locations

Study Contact

Medical Information
CONTACT
617-341-6777
medicalinfo@vrtx.com

Study Locations (Sites)

AMR Daphne, AL
Daphne, Alabama, 36526
United States
Long Beach Research Institute
Long Beach, California, 90805
United States
Clinical Trials Research
Sacramento, California, 95821
United States
Velocity Clinical Research - Banning
San Bernardino, California, 92408
United States
Velocity Clinical Research - Washington DC
Washington, District of Columbia, 20016
United States
AMR Fort Myers (The Clinical Study Center)
Fort Myers, Florida, 33912
United States
Velocity Clinical Research - Hallandale Beach
Hallandale Beach, Florida, 33009
United States
Accel Research Sites - Maitland
Maitland, Florida, 32751
United States
3Sync Research - Miami Lakes
Miami Lakes, Florida, 33014
United States
ARSN - NeuroStudies
Decatur, Georgia, 30030
United States
Velocity Clinical Research - Boise (Advanced Clinical Research)
Meridian, Idaho, 83642
United States
Healthcare Research Network II, LLC
Flossmoor, Illinois, 60422
United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451
United States
Healthcare Research Network
Hazelwood, Missouri, 63042
United States
Velocity Clinical Research - Norfolk
Norfolk, Nebraska, 68701
United States
Hassman Research Institute
Marlton, New Jersey, 08053
United States
Synexus Clinical Research- New York
New York, New York, 10017
United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
United States
Velocity Clinical Research - Grants Pass
Grants Pass, Oregon, 97527
United States
Be Well Clinical Studies - Austin
Round Rock, Texas, 78681
United States
Kalo Clinical Research
West Valley City, Utah, 84120
United States
Dominion Medical Associates, Inc.
Richmond, Virginia, 23219
United States
Northwest Clinical Research Center (NWCRC)
Bellevue, Washington, 98007
United States

Collaborators and Investigators

Sponsor: Vertex Pharmaceuticals Incorporated

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-01
Study Completion Date2027-05

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetic Peripheral Neuropathic Pain