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Taking peoplePhase 2

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

Key facts

Who runs it
Vertex Pharmaceuticals Incorporated
Where
Atlanta, Bakersfield, Beachwood, Beaumont, Cullman, Dallas, Decatur, DeLand, East Greenwich, Farmington Hills, Flossmoor, Fort Myers, Hallandale, Hazelwood, Jupiter, La Mesa, Meridian, Miami, Moncks Corner, Norfolk, Palmetto Bay, Port Saint Lucie, Raleigh, San Antonio, and Wheat Ridge, United StatesSee the 25 sitesAlso in 5 other countries, 23 sites
Status
Recruiting
Phase
Phase 2
People taking part
300 people, planned
Started
18 Oct 2024
Expected to end
22 Apr 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • VX-993
  • Pregabalin
  • Placebo (matched to pregabalin)
  • Placebo (matched to VX-993)
Record updated
1 June 2026

Who can take part

Age
18 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • Diagnosis of diabetes mellitus type 1 or type 2 with; Glycosylated hemoglobin A1c (HbA1c) less than or equal to (≤) 9% and; 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

Who cannot take part

  • History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
  • History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months; Other protocol defined Inclusion/Exclusion criteria may apply
  • Painful neuropathy other than DPN

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in United States

Also in 5 other countries, 23 sites

  • Atlanta Center for Medical ResearchAtlanta, United StatesNo longer taking part
  • Trovare Clinical Research - Bakersfield CABakersfield, United StatesNo longer taking part
  • Velocity Clinical Research, ClevelandBeachwood, United StatesNo longer taking part
  • Gadolin ResearchBeaumont, United StatesNo longer taking part
  • Cullman Clinical TrialsCullman, United StatesNo longer taking part
  • Velocity Clinical Research, DallasDallas, United StatesNo longer taking part
  • Accel Research - DecaturDecatur, United StatesNo longer taking part
  • Accel Research - DelandDeLand, United StatesNo longer taking part
  • Velocity Clinical Research, ProvidenceEast Greenwich, United StatesNo longer taking part
  • QUEST Research InstituteFarmington Hills, United StatesNo longer taking part
  • Healthcare Research Network - Flossmoor ILFlossmoor, United StatesNo longer taking part
  • AMR Fort Myers (The Clinical Study Center)Fort Myers, United StatesNo longer taking part
  • Velocity Clinical Research, Hallandale BeachHallandale, United StatesNo longer taking part
  • Healthcare Research Network - Hazelwood MOHazelwood, United StatesNo longer taking part
  • Health Awareness, Inc., JupiterJupiter, United StatesNo longer taking part
  • Eximia Research - San DiegoLa Mesa, United StatesNo longer taking part
  • Velocity Clinical Research, BoiseMeridian, United StatesNo longer taking part
  • Suncoast Research Associates - MiamiMiami, United StatesNo longer taking part
  • Clinical Trials of South Carolina - Berkeley - Moncks CornerMoncks Corner, United StatesNo longer taking part
  • AMR NorfolkNorfolk, United StatesNo longer taking part
  • Innovation Medical Research Center - PalmettoPalmetto Bay, United StatesNo longer taking part
  • Health Awareness, Inc. - Port St. LuciePort Saint Lucie, United StatesNo longer taking part
  • Eximia Research - RaleighRaleigh, United StatesNo longer taking part
  • San Antonio Clinical TrialsSan Antonio, United StatesNo longer taking part
  • Paradigm Clincial Research Centers, LLC., Wheat RidgeWheat Ridge, United StatesNo longer taking part

About the trial

What the trial wants to find out

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)

The 2 groups in the trial

  • VX-993Treatment being tested

    Participants will be randomized to receive multiple doses of different dose levels of VX-993.

    Treatment: VX-993 and Placebo (matched to pregabalin)

  • PregabalinExisting treatment, for comparison

    Participants will be randomized to receive Pregabalin.

    Treatment: Pregabalin and Placebo (matched to VX-993)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Fit questions
Built from NCT06619860, who can take part
Record updated
1 June 2026