Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)

Diabetic Peripheral Neuropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05660538
• Other study ID #: VX21-548-103
• Status: Completed
• Phase: Phase 2
• Start date: December 20, 2022
• Est. completion date: October 25, 2023

Study information

• Verified date: March 2024
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating Painful DPN.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: October 25, 2023
• Est. primary completion date: October 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• VX-548
Tablets for oral administration.
• Pregabalin
Capsules for oral administration.
• Placebo (matched to VX-548)
Placebo matched to VX-548 for oral administration.
• Placebo (matched to pregabalin)
Placebo matched to pregabalin for oral administration.

Locations

Country	Name	City	State
United States	Synexus Clinical Research- Anderson	Anderson	South Carolina
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Velocity Clinical Research - Banning	Banning	California
United States	Inquest Clinical Research	Baytown	Texas
United States	Northwest Clinical Research Center (NWCRC)	Bellevue	Washington
United States	Hassman Research Institute	Berlin	New Jersey
United States	Synexus Clinical Research US - Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital (BWH) - Translational Pain Research	Boston	Massachusetts
United States	Clinical Trials of South Carolina - Charleston	Charleston	South Carolina
United States	Synexus - Cincinnati	Cincinnati	Ohio
United States	Velocity Clinical Research - Cleveland	Cleveland	Ohio
United States	Lynn Institute of the Rockies	Colorado Springs	Colorado
United States	Synexus - Dallas	Dallas	Texas
United States	Revival Research Institute	Dearborn	Michigan
United States	Accel Research Sites - Neurostudies	Decatur	Georgia
United States	Velocity Clinical Research - Providence	East Greenwich	Rhode Island
United States	AMR El Dorado	El Dorado	Kansas
United States	Synexus Clinical Research - Evansville	Evansville	Indiana
United States	Carolina Institute for Clinical Research	Fayetteville	North Carolina
United States	Fleming Island Center for Clinical Research	Fleming Island	Florida
United States	Healthcare Research Network - Chicago	Flossmoor	Illinois
United States	AMR Fort Myers (The Clinical Study Center)	Fort Myers	Florida
United States	Triad Clinical Trials	Greensboro	North Carolina
United States	Velocity Clinical Research - Hallandale Beach	Hallandale Beach	Florida
United States	Healthcare Research Network - Hazelwood	Hazelwood	Missouri
United States	Synexus Clinical Research - Henderson	Henderson	Nevada
United States	Westside Center for Clinical Research	Jacksonville	Florida
United States	AMR Kansas City	Kansas City	Missouri
United States	Accel Research Sites - Tampa	Largo	Florida
United States	Long Beach Clinical Trials Services, Inc.	Long Beach	California
United States	Accel Research Sites - Maitland	Maitland	Florida
United States	Velocity Clinical Research - Medford	Medford	Oregon
United States	Velocity Clinical Research - Boise (Advanced Clinical Research)	Meridian	Idaho
United States	Suncoast Research Associates	Miami	Florida
United States	Clinical Trials of America, LLC	Monroe	Louisiana
United States	Synexus Clinical Research- New York	New York	New York
United States	AMR Newton	Newton	Kansas
United States	Boston Neuro Research Center, LLC	North Dartmouth	Massachusetts
United States	South Carolina Clinical Research	Orangeburg	South Carolina
United States	Synexus - Orlando	Orlando	Florida
United States	Synexus Clinical Research US - Phoenix West	Phoenix	Arizona
United States	Synexus Clinical Research US - St. Louis	Saint Louis	Missouri
United States	StudyMetrix Research, LLC	Saint Peters	Missouri
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Diabetes & Glandular Disease Clinic, P.A	San Antonio	Texas
United States	Synexus - The Villages	The Villages	Florida
United States	University Clinical Investigators	Tustin	California
United States	Boston PainCare Center	Waltham	Massachusetts
United States	AMR Wichita East, KS	Wichita	Kansas
United States	The Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS)		Baseline, Week 12
Secondary	Change from Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS)		Baseline, Week 12
Secondary	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		Baseline, Week 12
Secondary	Proportion of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment		At Week 12
Secondary	Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Day 1 up to Week 14