RecruitingPHASE2INTERVENTIONAL

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

This research study is testing a new medication, VX-993, for people experiencing ongoing pain caused by diabetic nerve damage, also known as diabetic peripheral neuropathy (DPN). The main goals are to find out how well VX-993 reduces pain, if it causes any unwanted side effects, and how well people tolerate it. Participants will be given either VX-993, an existing pain medication called Pregabalin, or a dummy pill (placebo). This will help the researchers understand if VX-993 is a safe and effective treatment option for this type of pain. The study is for adults aged 18 to 80 years old, both men and women.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Vertex Pharmaceuticals Incorporated

Enrolment target

300

Start

18 Oct 2024

Estimated completion

22 Apr 2027

Diabetic Peripheral Neuropathic Pain

What is this study about?

If you live with diabetes, you might experience a common complication called diabetic peripheral neuropathy (DPN). This is when high blood sugar levels damage nerves, most often in the legs and feet, leading to pain, tingling, or numbness. This pain can be constant and significantly affect daily life.

This particular study is a 'Phase 2' trial, which means it's an important step in developing new medicines. At this stage, researchers are trying to get a better understanding of how a new drug, in this case, VX-993, works in a larger group of people than in earlier tests. They want to see if it is effective in reducing the pain associated with DPN and to carefully monitor its safety.

By comparing VX-993 to an established treatment (Pregabalin) and a placebo (a 'dummy' pill with no active medicine), the researchers can gather crucial information. This comparison helps them determine if VX-993 genuinely helps relieve pain and is well-tolerated by patients, and if it could potentially become a new treatment option for this challenging condition. This type of research is vital for finding new and better ways to manage pain for people with DPN.

Key takeaways

This study is testing a new drug (VX-993) for pain from diabetic nerve damage.
It's for adults aged 18-80 with type 1 or type 2 diabetes and long-term nerve pain.
Participants will receive VX-993, an existing drug (Pregabalin), or a dummy pill.
The main goals are to check how well VX-993 reduces pain and whether it's safe.
You will have regular check-ups and monitoring if you join.
You can stop participating at any point if you wish.

Who may be eligible?

To join this study, you would need to be between 18 and 80 years old. You must have been diagnosed with either type 1 or type 2 diabetes. Importantly, you need to have ongoing pain in both of your lower legs or feet that is specifically due to diabetic nerve damage, and this pain should have been present for at least a year.

There are also some important reasons why you might not be able to join. For example, if your pain is caused by something other than diabetic nerve damage, or if you have certain heart rhythm problems that require medication. Also, if you've had a heart attack or stroke in the past 12 months, you wouldn't be able to take part.

Keep in mind that there might be other specific health factors that the study team will consider when deciding if this study is right for you. They will review all your medical information carefully.

Quick self-check

Are you between 18 and 80 years old?
Do you have type 1 or type 2 diabetes?
Do you have pain in both your lower legs or feet due to diabetes for at least 1 year?
Have you had a heart attack or stroke in the last 12 months? (If yes, you may not be eligible)
Do you have any heart rhythm problems needing medication? (If yes, you may not be eligible)

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would likely have a screening visit where doctors check if you meet all the requirements. If you do, you would then be randomly assigned to receive one of the study treatments: the new medication VX-993, an existing medication called Pregabalin, or a placebo (a dummy pill). You wouldn't know which one you are getting. You would take the assigned medication regularly as instructed by the study team.

The study would involve several visits to the clinic for medical check-ups, blood tests, and to answer questions about your pain and any side effects you might be experiencing. These visits are important for monitoring your health and the effects of the treatment. The total duration of your participation in the study, including all treatments and follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in this study could offer several potential benefits. You might experience a reduction in your diabetic nerve pain, and you would receive close medical monitoring throughout the trial. However, there are also potential risks; you might experience side effects from the study medication, or the treatment might not improve your pain. Since you might receive a placebo, there's a chance you wouldn't get any active medication. Your health and safety are paramount, and you would have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (47)

Cullman Clinical Trials
Cullman, United States· Completed
Trovare Clinical Research - Bakersfield CA
Bakersfield, United States· Completed
Eximia Research - San Diego
La Mesa, United States· Completed
Paradigm Clincial Research Centers, LLC., Wheat Ridge
Wheat Ridge, United States· Completed
Accel Research - Deland
DeLand, United States· Completed
AMR Fort Myers (The Clinical Study Center)
Fort Myers, United States· Completed
Velocity Clinical Research - Hallandale Beach
Hallandale, United States· Completed
Health Awareness, Inc., Jupiter
Jupiter, United States· Completed
Suncoast Research Associates - Miami
Miami, United States· Completed
Innovation Medical Research Center - Palmetto
Palmetto Bay, United States· Completed
Health Awareness, Inc. - Port St. Lucie
Port Saint Lucie, United States· Completed
Atlanta Center for Medical Research
Atlanta, United States· Completed

+35 more sites — see the official record for the full list.

Common questions

What is diabetic peripheral neuropathy?

It's nerve damage often in the legs and feet, caused by high blood sugar levels in people with diabetes, leading to pain, tingling, or numbness.

What does 'Phase 2' mean for a trial?

It means the drug is being tested in a larger group of people to see if it works and to check for side effects, after earlier safety tests.

What is a placebo?

A placebo is a 'dummy' pill or treatment that looks like the real medicine but contains no active ingredients. It helps researchers see if the actual medicine truly works.

Will I know which treatment I'm getting?

No, you will be randomly assigned to one of the treatments (VX-993, Pregabalin, or placebo), and neither you nor the study team will know which one you are receiving. This is called 'blinding' and helps ensure fair results.

Can I leave the study if I change my mind?

Yes, you are completely free to leave the study at any time, for any reason, without your decision affecting your current or future medical care.

How to find out more

Medical Information

medicalinfo@vrtx.com 617-341-6777 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.