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

Phase 2

Completed

• Conditions: Diabetic Peripheral Neuropathy
• Interventions: Drug: VX-548; Drug: Pregabalin; Drug: Placebo (matched to pregabalin); Drug: Placebo (matched to VX-548)

• Registration Number: NCT05660538
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2022-12-13
• Study Start: 2022-12-20
• Study First Posted: 2022-12-21
• Primary Completion: 2023-10-12
• Study Completion: 2023-10-25
• Disposition First Submitted: 2024-10-10
• Disposition First Posted: 2024-10-15
• Status Verified: 2025-06
• Results First Submitted: 2025-06-13
• Results First Submitted QC: 2025-06-13
• Last Update Submitted: 2025-06-13
• Results First Posted: 2025-07-01
• Last Update Posted: 2025-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VX-548	VX-548	Participants will be randomized to receive different dose levels of VX-548.
VX-548	Placebo (matched to pregabalin)	Participants will be randomized to receive different dose levels of VX-548.
Pregabalin	Placebo (matched to VX-548)	Participants will receive pregabalin.
Pregabalin	Pregabalin	Participants will receive pregabalin.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS)	Baseline, At Week 12	Change from baseline in the weekly mean of the daily Numeric Pain Rating Scale (NPRS) score assessing average pain intensity in the last 24 hours. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS) Score	Baseline, At Week 12	Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) score, which asks participants to describe how pain interfered with the participant's sleep. Response options for the DSIS range from 0 (none) to 10 (severe).
Percentage of Participants With Greater Than or Equal to (≥) 30 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS	Baseline, At Week 12	Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.; The percentage of participants with ≥30% reduction from baseline in the weekly average NPRS score at Week 12 was reported.
Percentage of Participants With ≥50 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS	Baseline, At Week 12	Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.The percentage of participants with ≥50% reduction from baseline in the weekly average NPRS score at Week 12 was reported.
Percentage of Participants With ≥70 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS	Baseline, At Week 12	Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.; The percentage of participants with ≥70% reduction from baseline in the weekly average NPRS score at Week 12 was reported.
Percentage of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment	Baseline, At Week 12	PGIC is an instrument that measures change in participants' overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Day 1 up to Week 14

Trial Locations

Locations (50)

Pinnacle Research Group, LLC; 🇺🇸 Anniston, Alabama, United States

Synexus Clinical Research US - Birmingham; 🇺🇸 Birmingham, Alabama, United States

Synexus Clinical Research US - Phoenix West; 🇺🇸 Phoenix, Arizona, United States

Velocity Clinical Research - Banning; 🇺🇸 Banning, California, United States

Long Beach Clinical Trials Services, Inc.; 🇺🇸 Long Beach, California, United States

University Clinical Investigators; 🇺🇸 Tustin, California, United States

Lynn Institute of the Rockies; 🇺🇸 Colorado Springs, Colorado, United States

Fleming Island Center for Clinical Research; 🇺🇸 Fleming Island, Florida, United States

AMR Fort Myers (The Clinical Study Center); 🇺🇸 Fort Myers, Florida, United States

Velocity Clinical Research - Hallandale Beach; 🇺🇸 Hallandale Beach, Florida, United States

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