Clinical trial NCT06619860: Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetic Peripheral Neuropathic Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: 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.

Primary outcomes:
measure: 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
measure: 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
Secondary outcomes:
measure: 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
measure: 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
measure: 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
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Cullman Clinical Trials
state: Alabama
city: Bakersfield
country: United States
facility: Trovare Clinical Research
state: California
city: La Mesa
country: United States
facility: Eximia Research-CA, LLC
state: California
city: Wheat Ridge
country: United States
facility: Paradigm Clincial Research Centers, LLC., Wheat Ridge
state: Colorado
city: DeLand
country: United States
facility: Accel Research Site - Deland Clinical Research Unit
state: Florida
city: Fort Myers
country: United States
facility: AMR Fort Myers (The Clinical Study Center)
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research - Hallandale Beach
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc., Jupiter
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates - Miami
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center
state: Florida
city: Port Saint Lucie
country: United States
facility: Health Awareness - PSL
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Decatur
country: United States
facility: ARSN - NeuroStudies
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise (Advanced Clinical Research)
state: Idaho
city: Flossmoor
country: United States
facility: Healthcare Research Network II, LLC
state: Illinois
city: Farmington Hills
country: United States
facility: Quest Research Institute
state: Michigan
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: Raleigh
country: United States
facility: Eximia Research - Raleigh
state: North Carolina
city: Beachwood
country: United States
facility: Velocity Clinical Research - Cleveland
state: Ohio
city: East Greenwich
country: United States
facility: Velocity Clinical Research - Providence
state: Rhode Island
city: Moncks Corner
country: United States
facility: Clinical Trials of South Carolina - Berkeley
state: South Carolina
city: Beaumont
country: United States
facility: Gadolin Research
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: San Antonio
country: United States
facility: San Antonio Clinical Trials
state: Texas
city: Norfolk
country: United States
facility: AMR Norfolk
state: Virginia
city: Brampton
country: Canada
facility: LMC Clinical Research Inc. d.b.a. Centricity Research
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials
city: Montreal
country: Canada
facility: Altasciences Montreal
city: Berlin
country: Germany
facility: emovis GmbH
city: Offenbach/Main
country: Germany
facility: FutureMeds Frankfurt
city: Birmingham
country: United Kingdom
facility: FutureMeds Birmingham
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: London
country: United Kingdom
facility: St Pancras Clinical Research
city: Nuneaton
country: United Kingdom
facility: George Eliot Hospital NHS Trust - Diabetes and Endocrinology Centre
Study officials:
References: