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VX-993 for Diabetic Neuropathy

Phase 2
Recruiting
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of diabetes mellitus type 1 or type 2 with Glycosylated hemoglobin A1c (HbA1c) ≤ 9%
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
Must not have
Painful neuropathy other than DPN
History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

"This trial aims to test how well VX-993 works, and whether it is safe and well-tolerated for people with pain caused by Diabetic Peripheral Neuropathy."

Who is the study for?
This trial is for people with type 1 or type 2 diabetes who have been experiencing pain in both lower extremities due to Diabetic Peripheral Neuropathy (DPN) for at least a year. Their HbA1c levels must be ≤9%. It's not suitable for individuals who don't meet these specific criteria.
What is being tested?
The study is testing the effectiveness and safety of a new medication called VX-993, comparing it against Pregabalin (an existing drug for DPN pain), and placebo versions of both drugs. Participants will randomly receive one of these treatments to assess their impact on DPN pain.
What are the potential side effects?
Potential side effects may include discomfort at the injection site, typical reactions associated with medications like VX-993 or Pregabalin such as dizziness, sleepiness, swelling in limbs, and other possible drug-related adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have diabetes with an HbA1c level of 9% or lower.
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I have had pain in both legs for over a year due to diabetic nerve damage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have nerve pain not caused by diabetes.
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I am on medication for irregular heartbeats.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: VX-993Experimental Treatment2 Interventions
Participants will be randomized to receive multiple doses of different dose levels of VX-993.
Group II: PregabalinActive Control2 Interventions
Participants will be randomized to receive Pregabalin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo (matched to pregabalin)
2022
Completed Phase 2
~200
VX-993
2024
Completed Phase 1
~180

Find a Location

Who is running the clinical trial?

Vertex Pharmaceuticals IncorporatedLead Sponsor
257 Previous Clinical Trials
34,769 Total Patients Enrolled
~200 spots leftby Apr 2026
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