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Completed

NCT Number: NCT05660538

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

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

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Key information

Conditions

Diabetic Peripheral Neuropathy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pinnacle Research Group, LLC, Anniston, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suzetrigine

Drug

Tablets for oral administration.

Other names: VX-548, SUZ

Pregabalin

Drug

Capsules for oral administration.

Placebo (matched to SUZ)

Drug

Placebo matched to SUZ for oral administration.

Placebo (matched to pregabalin)

Drug

Placebo matched to pregabalin for oral administration.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS) Score

    Time frame: 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).

  2. 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

    Time frame: 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.

  3. Percentage of Participants With ≥50 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS

    Time frame: 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.

  4. Percentage of Participants With ≥70 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS

    Time frame: 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.

  5. Percentage of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment

    Time frame: 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).

  6. Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Day 1 up to Week 14

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2022
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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