Clinical trial NCT05660538: Evaluation of Efficacy and Safety of VX-548 for Painful 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 VX-548 in Subjects With Painful Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2022-12-21
Enrollment: 192
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 and safety of VX-548 doses in treating Painful DPN.


Eligibility criteria: Key Inclusion Criteria:

* Diagnosis of diabetes mellitus type 1 or type 2 with

  * Glycosylated hemoglobin A1c (HbA1c) ≤9%; and
  * Presence of bilateral pain in lower extremities due to DPN 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 a Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change from Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS)
timeFrame: Baseline, Week 12
measure: Proportions of Participants With Greater Than or Equal to (≥) 30 Percent (%), ≥50%, and ≥70% Reductions from Baseline in the Weekly Average of Daily Pain Intensity on the NPRS
timeFrame: Baseline, Week 12
measure: Proportion of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment
timeFrame: At 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 14
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Birmingham
country: United States
facility: Synexus Clinical Research US - Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Synexus Clinical Research US - Phoenix West
state: Arizona
city: Banning
country: United States
facility: Velocity Clinical Research - Banning
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials Services, Inc.
state: California
city: Tustin
country: United States
facility: University Clinical Investigators
state: California
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies
state: Colorado
city: Fleming Island
country: United States
facility: Fleming Island Center for Clinical Research
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: Jacksonville
country: United States
facility: Westside Center for Clinical Research
state: Florida
city: Largo
country: United States
facility: Accel Research Sites - Tampa
state: Florida
city: Maitland
country: United States
facility: Accel Research Sites - Maitland
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates
state: Florida
city: Orlando
country: United States
facility: Synexus - Orlando
state: Florida
city: The Villages
country: United States
facility: Synexus - The Villages
state: Florida
city: Decatur
country: United States
facility: Accel Research Sites - 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 - Chicago
state: Illinois
city: Evansville
country: United States
facility: Synexus Clinical Research - Evansville
state: Indiana
city: El Dorado
country: United States
facility: AMR El Dorado
state: Kansas
city: Newton
country: United States
facility: AMR Newton
state: Kansas
city: Wichita
country: United States
facility: AMR Wichita East, KS
state: Kansas
city: Monroe
country: United States
facility: Clinical Trials of America, LLC
state: Louisiana
city: Boston
country: United States
facility: Brigham and Women's Hospital (BWH) - Translational Pain Research
state: Massachusetts
city: North Dartmouth
country: United States
facility: Boston Neuro Research Center, LLC
state: Massachusetts
city: Waltham
country: United States
facility: Boston PainCare Center
state: Massachusetts
city: Dearborn
country: United States
facility: Revival Research Institute
state: Michigan
city: Hazelwood
country: United States
facility: Healthcare Research Network - Hazelwood
state: Missouri
city: Kansas City
country: United States
facility: AMR Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Synexus Clinical Research US - St. Louis
state: Missouri
city: Saint Peters
country: United States
facility: StudyMetrix Research, LLC
state: Missouri
city: Henderson
country: United States
facility: Synexus Clinical Research - Henderson
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: New York
country: United States
facility: Synexus Clinical Research- New York
state: New York
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research
state: North Carolina
city: Greensboro
country: United States
facility: Triad Clinical Trials
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Synexus - Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Velocity Clinical Research - Cleveland
state: Ohio
city: Medford
country: United States
facility: Velocity Clinical Research - Medford
state: Oregon
city: East Greenwich
country: United States
facility: Velocity Clinical Research - Providence
state: Rhode Island
city: Anderson
country: United States
facility: Synexus Clinical Research- Anderson
state: South Carolina
city: Charleston
country: United States
facility: Clinical Trials of South Carolina - Charleston
state: South Carolina
city: Orangeburg
country: United States
facility: South Carolina Clinical Research
state: South Carolina
city: Baytown
country: United States
facility: Inquest Clinical Research
state: Texas
city: Dallas
country: United States
facility: Synexus - Dallas
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Clinic, P.A
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center (NWCRC)
state: Washington
Study officials:
References: