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

NCT06619860
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Recruiting
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Participants
300
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Lead sponsor
Vertex Pharmaceuticals Incorporated
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Start date
2024-10-18
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Number of sites
47
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Summary
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)
clinicaltrials.gov
Short title
Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy
clinicaltrials.gov
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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-04-22
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First posted
2024-10-01
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Registry last updated
2026-06-01
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Primary completion date
2027-03-25
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Start date
2024-10-18
clinicaltrials.gov

Participants
300
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Participant count basis
Estimated
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Planned participants
300
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Protocol amendments
3
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Number of sites
47
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Registry sponsor category
Industry
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Lead sponsor
Vertex Pharmaceuticals Incorporated
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06619860
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06619860
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12

    Timeframe: From Baseline up to Week 12

  1. Proportion of Participants with Greater than or Equal to (≥) 30 Percent (%) Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12

    Timeframe: From Baseline up to Week 12

  2. Proportion of Participants with ≥50% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12

    Timeframe: From Baseline up to Week 12

  3. Proportion of Participants with ≥70% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12

    Timeframe: From Baseline up to Week 12

  4. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Timeframe: Day 1 up to Week 16

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • Painful neuropathy other than DPN
  • 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.

Sources for eligibility
clinicaltrials.gov

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

And 22 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-514689-38-01
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (26)