Health TrialsbyHealthPanel

Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy

ConditionDiabetic Peripheral Neuropathic Pain
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVertex Pharmaceuticals Incorporated

About this trial

The purpose of this study is to evaluate the efficacy, safety, and tolerability of VX-993 in participants with pain associated with Diabetic Peripheral Neuropathy (DPN)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of diabetes mellitus type 1 or type 2 with

Glycosylated hemoglobin A1c (HbA1c) less than or equal to (≤) 9% and

Presence of bilateral pain in lower extremities due to DPN (defined as a symmetric, length-dependent sensory or sensorimotor polyneuropathy) for at least 1 year

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • VX-993

    Drug

    Tablets for oral administration.

  • Pregabalin

    Drug

    Capsules for oral administration.

  • Placebo (matched to pregabalin)

    Drug

    Placebo matched to pregabalin for oral administration.

  • Placebo (matched to VX-993)

    Drug

    Placebo matched to VX-993 for oral administration.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: VX-993Experimental treatment 2 interventions
Group B: PregabalinActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12

Time frame
From Baseline up to Week 12

Secondary outcomes

1

Proportion of Participants with Greater than or Equal to (≥) 30 Percent (%) Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12

Time frame
From Baseline up to Week 12
2

Proportion of Participants with ≥50% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12

Time frame
From Baseline up to Week 12
3

Proportion of Participants with ≥70% Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12

Time frame
From Baseline up to Week 12
4

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 16

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vertex Pharmaceuticals Incorporated

Lead sponsor

Source ClinicalTrials.gov
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