RECRUITING

Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy

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 VX-993 in participants with pain associated with Diabetic Peripheral Neuropathy (DPN)

Official Title

A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of Oral VX-993 in Subjects With Pain Associated With Diabetic Peripheral Neuropathy

Quick Facts

Study Start:2024-10-18
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06619860

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. * Diagnosis of diabetes mellitus type 1 or type 2 with
  2. * Glycosylated hemoglobin A1c (HbA1c) less than or equal to (≤) 9% and
  3. * Presence of bilateral pain in lower extremities due to DPN (defined as a symmetric,length-dependent sensory or sensorimotor polyneuropathy) for at least 1 year
  1. * Painful neuropathy other than DPN
  2. * History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
  3. * History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Trovare Clinical Research
Bakersfield, California, 93301
United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
United States
Velocity Clinical Research - Boise (Advanced Clinical Research)
Meridian, Idaho, 83642
United States
Healthcare Research Network II, LLC
Flossmoor, Illinois, 60422
United States
Healthcare Research Network
Hazelwood, Missouri, 63042
United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
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 Date2024-10-18
Study Completion Date2026-05

Study Record Updates

Study Start Date2024-10-18
Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetic Peripheral Neuropathic Pain