VX-993

Clinical trials are investigating VX-993 in people with pain linked to diabetic peripheral neuropathy, a type of nerve pain caused by diabetes. The studies aim to evaluate whether VX-993 can reduce pain and how safe and tolerable it is. The current trial is in adults with this condition.

Table of Contents

Trial overview

The clinical trial for VX-993 is titled Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy.[1]

This is an interventional study, which means researchers give study treatment and then measure the results.[1]

The trial is in Phase 2 and is marked Authorised.[1]

The planned enrollment is 300 people.[1]

Who is being studied

This trial is studying people with pain associated with diabetic peripheral neuropathy.[1]

Diabetic peripheral neuropathy is nerve damage caused by diabetes, and it can lead to pain in the feet, hands, or other areas.[1]

The source data say the study is for subjects with this condition, but they do not give more detail about age limits or other eligibility rules.[1]

What the study measures

The main goal is to see whether VX-993 can improve pain in people with diabetic peripheral neuropathy.[1]

Researchers are also studying safety and tolerability, which means how well the treatment can be used and how well people can handle it.[1]

The primary outcome is the change from baseline in the weekly average of daily pain intensity on the numeric pain rating scale (NPRS) at Week 12.[1]

In simple terms, this means the study compares pain at the start with pain after 12 weeks to see if symptoms improve.[1]

Study design and treatment groups

The intervention list shows VX-993 tablet and placebo groups, and it also lists pregabalin and pregabalin placebo.[1]

A placebo is a look-alike treatment with no active study drug, used so researchers can compare results more fairly.[1]

The trial data do not provide more detail about the exact group assignment method, but they do show that VX-993 is being compared with placebo and with pregabalin-related study groups.[1]

What the results may mean

This trial is designed to answer a practical question: can VX-993 reduce pain in people living with diabetes-related nerve pain?[1]

Because it is a Phase 2 study, the results may help show whether the treatment is promising enough for later research.[1]

The study focuses on patient-reported pain scores, so the results depend on how participants rate their own pain over time.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06619860 Phase 2 Pain associated with diabetic peripheral neuropathy Authorised 300

Ongoing Clinical Trials on VX-993

  • Study on the Effectiveness and Safety of VX-993 and Pregabalin for Pain Relief in Patients with Diabetic Peripheral Neuropathy

    Recruiting

    2 1 1
    Investigated drugs:
    France Germany Italy

Glossary

  • Diabetic peripheral neuropathy: Nerve damage caused by diabetes that can lead to pain, numbness, or tingling, usually in the feet or hands.
  • Pain intensity: How strong pain feels to the person reporting it.
  • Numeric pain rating scale (NPRS): A pain scale where people rate their pain with numbers, often to show how severe the pain is.
  • Baseline: The starting point before treatment begins. Results are compared with this point.
  • Weekly average: The average result from several days in one week.
  • Daily pain intensity: How strong the pain feels each day.
  • Week 12: The 12th week of the study, when some results are checked.
  • Safety: How well a treatment can be used without causing harmful problems.
  • Tolerability: How well people can handle a treatment.
  • Phase 2: A mid-stage clinical trial that looks at whether a treatment may work and continues to study safety.
  • Interventional study: A study where researchers give a treatment and then measure the results.

References