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

Primary Purpose

Diabetic Peripheral Neuropathy

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VX-548
Pregabalin
Placebo (matched to VX-548)
Sponsored by
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pinnacle Research Group, LLC
  • Synexus Clinical Research US - Birmingham
  • Synexus Clinical Research US - Phoenix West
  • Velocity Clinical Research - Banning
  • Long Beach Clinical Trials Services, Inc.
  • University Clinical Investigators
  • Lynn Institute of the Rockies
  • Fleming Island Center for Clinical Research
  • AMR Fort Myers (The Clinical Study Center)
  • Velocity Clinical Research - Hallandale Beach
  • Westside Center for Clinical Research
  • Accel Research Sites - Tampa
  • Accel Research Sites - Maitland
  • Suncoast Research Associates
  • Synexus - Orlando
  • Synexus - The Villages
  • Accel Research Sites - Neurostudies
  • Velocity Clinical Research - Boise (Advanced Clinical Research)
  • Healthcare Research Network - Chicago
  • Synexus Clinical Research - Evansville
  • AMR El Dorado
  • AMR Newton
  • AMR Wichita East, KS
  • Clinical Trials of America, LLC
  • Brigham and Women's Hospital (BWH) - Translational Pain Research
  • Boston Neuro Research Center, LLC
  • Boston PainCare Center
  • Revival Research Institute
  • Healthcare Research Network - Hazelwood
  • AMR Kansas City
  • Synexus Clinical Research US - St. Louis
  • StudyMetrix Research, LLC
  • Synexus Clinical Research - Henderson
  • Hassman Research Institute
  • Synexus Clinical Research- New York
  • Carolina Institute for Clinical Research
  • Triad Clinical Trials
  • The Center for Clinical Research
  • Synexus - Cincinnati
  • Velocity Clinical Research - Cleveland
  • Velocity Clinical Research - Medford
  • Velocity Clinical Research - Providence
  • Synexus Clinical Research- Anderson
  • Clinical Trials of South Carolina - Charleston
  • South Carolina Clinical Research
  • Inquest Clinical Research
  • Synexus - Dallas
  • Diabetes & Glandular Disease Clinic, P.A
  • Wasatch Clinical Research
  • Northwest Clinical Research Center (NWCRC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VX-548

Pregabalin

Arm Description

Participants will be randomized to receive different dose levels of VX-548.

Participants will receive pregabalin.

Outcomes

Primary Outcome Measures

Change from Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS)

Secondary Outcome Measures

Change from Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS)
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
Proportion of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Full Information

First Posted
December 13, 2022
Last Updated
September 5, 2023
Sponsor
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT05660538
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VX-548
Arm Type
Experimental
Arm Description
Participants will be randomized to receive different dose levels of VX-548.
Arm Title
Pregabalin
Arm Type
Active Comparator
Arm Description
Participants will receive pregabalin.
Intervention Type
Drug
Intervention Name(s)
VX-548
Intervention Description
Tablets for oral administration.
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Capsules for oral administration.
Intervention Type
Drug
Intervention Name(s)
Placebo (matched to VX-548)
Intervention Description
Placebo matched to VX-548 for oral administration.
Primary Outcome Measure Information:
Title
Change from Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS)
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change from Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS)
Time Frame
Baseline, Week 12
Title
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
Time Frame
Baseline, Week 12
Title
Proportion of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment
Time Frame
At Week 12
Title
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Day 1 up to Week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Synexus Clinical Research US - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Synexus Clinical Research US - Phoenix West
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Velocity Clinical Research - Banning
City
Banning
State/Province
California
ZIP/Postal Code
92220
Country
United States
Facility Name
Long Beach Clinical Trials Services, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
University Clinical Investigators
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Lynn Institute of the Rockies
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
Fleming Island Center for Clinical Research
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Facility Name
AMR Fort Myers (The Clinical Study Center)
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Velocity Clinical Research - Hallandale Beach
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009-4427
Country
United States
Facility Name
Westside Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
Accel Research Sites - Tampa
City
Largo
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
Accel Research Sites - Maitland
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Suncoast Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Synexus - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806-1041
Country
United States
Facility Name
Synexus - The Villages
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162-7116
Country
United States
Facility Name
Accel Research Sites - Neurostudies
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Velocity Clinical Research - Boise (Advanced Clinical Research)
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Healthcare Research Network - Chicago
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Facility Name
Synexus Clinical Research - Evansville
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
AMR El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
AMR Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
AMR Wichita East, KS
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Clinical Trials of America, LLC
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Brigham and Women's Hospital (BWH) - Translational Pain Research
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston Neuro Research Center, LLC
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Boston PainCare Center
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Revival Research Institute
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48126
Country
United States
Facility Name
Healthcare Research Network - Hazelwood
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Facility Name
AMR Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114-4866
Country
United States
Facility Name
Synexus Clinical Research US - St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
StudyMetrix Research, LLC
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303-3041
Country
United States
Facility Name
Synexus Clinical Research - Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Synexus Clinical Research- New York
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Carolina Institute for Clinical Research
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28303
Country
United States
Facility Name
Triad Clinical Trials
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Synexus - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Velocity Clinical Research - Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Velocity Clinical Research - Medford
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Velocity Clinical Research - Providence
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Facility Name
Synexus Clinical Research- Anderson
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Clinical Trials of South Carolina - Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
South Carolina Clinical Research
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Inquest Clinical Research
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Synexus - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234-7858
Country
United States
Facility Name
Diabetes & Glandular Disease Clinic, P.A
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-4801
Country
United States
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Northwest Clinical Research Center (NWCRC)
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007-4209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Learn more about this trial

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

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