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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of a new treatment for pain associated with diabetic peripheral neuropathy. Diabetic peripheral neuropathy is a condition that affects the nerves in the lower extremities, often causing pain. The study will test a medication called VX-993, which is a tablet designed to help manage this type of pain. VX-993 works by inhibiting a specific sodium channel in the body, which is thought to play a role in pain sensation. Another medication, pregabalin, which is commonly used to treat nerve pain, will also be used in the study for comparison. Some participants will receive a placebo, which looks like the medication but does not contain any active ingredients.

The purpose of the study is to evaluate how well different doses of VX-993 can reduce pain in people with diabetic peripheral neuropathy and to assess its safety. Participants will take the medication orally, and the study will last for up to 12 weeks. During this time, participants will be monitored for any changes in their pain levels and any side effects they might experience. The study will also compare the effects of VX-993 with those of pregabalin to see which is more effective in managing pain.

Throughout the study, participants will have regular check-ins to track their progress and ensure their safety. The main goal is to see if VX-993 can significantly reduce pain compared to the placebo and pregabalin. The study will also look at how well participants tolerate the medication, considering any adverse effects, changes in laboratory test results, and vital signs. This research aims to provide a better understanding of how VX-993 can be used to help people with diabetic peripheral neuropathy manage their pain more effectively.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be randomly assigned to one of the treatment groups. This means you will either receive the actual medication or a placebo, which is a pill that looks like the medication but does not contain the active substance.
Step 2
Medication administration
You will take the assigned medication orally in the form of a tablet. The medication could be VX-993, pregabalin, or a placebo. The exact dosage and frequency will be provided by the study team.
The treatment will last for a specified period, and you will be required to take the medication as instructed throughout the study duration.
Step 3
Regular assessments
Throughout the study, you will undergo regular assessments to monitor your health and the effects of the medication. These assessments may include laboratory tests, checking vital signs, and electrocardiograms (ECGs), which measure the electrical activity of your heart.
Step 4
Pain evaluation
You will be asked to rate your daily pain intensity using a numeric pain rating scale (NPRS). This will help evaluate any changes in your pain levels over time.
The primary goal is to observe any change from the beginning of the study to week 12 in the average of your daily pain intensity.
Step 5
Safety monitoring
Your safety will be closely monitored throughout the study. This includes tracking any adverse events, which are any unwanted effects you might experience during the trial.
The study team will also review your laboratory test results and other health indicators to ensure your well-being.
Step 6
Completion of the study
At the end of the study period, you will have a final assessment to evaluate the overall effects of the treatment.
The study is expected to conclude by September 8, 2025, and you will be informed about the results and any further steps if necessary.

Who can join the trial?

7 criteria

Must have a diagnosis of diabetes mellitus type 1 or type 2.
Must have a glycosylated hemoglobin A1c (HbA1c) level of 9% or less. HbA1c is a blood test that shows your average blood sugar level over the past 2 to 3 months.
Must have, in the opinion of the study doctor, optimized glycemic control. This means your blood sugar levels are well-managed.
Must have been stable on anti-diabetic medicine or dietary treatment for at least 3 months before the first screening visit.
Must have bilateral pain in the lower extremities (both legs) due to diabetic peripheral neuropathy for at least 1 year. Diabetic peripheral neuropathy is a type of nerve damage that can occur with diabetes, often causing pain in the legs.
Both male and female participants are eligible.
Participants must not be part of a vulnerable population.

Who cannot join the trial?

3 criteria

Patients who do not have pain associated with diabetic peripheral neuropathy cannot participate. This means if you do not have pain caused by nerve damage due to diabetes, you cannot join.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. This means if you are in a group that needs special protection, you cannot join.

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Verified sites

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Verified
CHU Gabriel-Montpied
Clermont Ferrand, France
Verified
Centre Hospitalier Universitaire De Nimes
Nimes, France
Responsive
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
Bad Oeynhausen, Germany

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Investigated drugs

VX-993 is an experimental medication being tested for its ability to relieve pain in people with diabetic peripheral neuropathy, a condition that causes nerve pain due to diabetes. This medication is taken by mouth and is being studied to see how well it works in reducing pain and how safe it is for patients to use. The trial aims to find out if VX-993 can help manage the pain associated with this condition and to ensure that it does not cause any harmful side effects.

What is already known about the treatment

VX-993 – VX-993 is an oral medication currently being studied in clinical trials for its effectiveness and safety in treating pain associated with diabetic peripheral neuropathy, a condition that causes nerve pain due to diabetes. This medication is in the experimental phase, meaning it is not yet widely available or fully approved for general medical use. The main goal of VX-993 is to reduce pain by targeting specific pathways in the body that are involved in pain signaling, although the exact molecular mechanism is still under investigation. It is classified as a potential treatment for neuropathic pain, focusing on improving the quality of life for individuals suffering from this type of chronic pain.

Investigated diseases

Pain Associated With Diabetic Peripheral Neuropathy – This condition occurs when high blood sugar levels cause nerve damage, particularly in the extremities like the feet and hands. It is a common complication of diabetes, leading to sensations of pain, tingling, or numbness. The pain can be constant or intermittent and may worsen at night. Over time, the nerve damage can progress, leading to a loss of sensation in the affected areas. This can increase the risk of injuries and infections, as individuals may not feel pain from cuts or sores. The progression of nerve damage can vary, but it often worsens if blood sugar levels are not well controlled.