At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- VX-993 (drug), Pregabalin (drug), Placebo (matched to pregabalin) (drug), Placebo (matched to VX-993) (drug)
- How long the study runs
- Study runs about 30 months (dates as stated)
- About the drug or intervention
- 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.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is testing a treatment called VX-993 for pain caused by diabetic peripheral neuropathy (DPN) — nerve damage linked to diabetes that can cause pain in both legs or feet. The researchers want to find out how well VX-993 works and how safe it is. The study is run by Vertex Pharmaceuticals Incorporated, and there may be other rules about who can take part.
Who can take part
- You have type 1 or type 2 diabetes.
- Your HbA1c (glycosylated haemoglobin — a blood test that shows your average blood sugar) is 9% or less.
- You have had pain in both of your lower legs or feet for at least 1 year, caused by diabetic peripheral neuropathy.
Who may not be able to
- You have nerve pain caused by something other than diabetic peripheral neuropathy.
- You have had an abnormal heart rhythm that needed treatment.
- You have had a heart attack (myocardial infarction) or a stroke in the past 12 months.
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team (how many visits, how long the study lasts, and what taking part involves are not given).
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 80 Years
- Who
- All
- Number of participants
- 300
- Started
- 2024-10-18
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for diabetic peripheral neuropathic pain
- • Phase2 - 300 participants
- • 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)
Who can take part?
- • Ages 18 Years to 80 Years
- • Diagnosed with diabetic peripheral neuropathic pain
Where?
- • Birmingham - Birmingham Heartlands Hospital - Heartlands Hospital Diabetes Centre and MIDRU
- • Birmingham - FutureMeds Birmingham
- • Dundee - Ninewells Hospital - Endocrinology
- • Glasgow - FutureMeds Glasgow
- • +5 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
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)
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 80 Years
- Who can join: All genders
What the study is looking for
- ✓Diagnosis of diabetes mellitus type 1 or type 2 with
- ✓Glycosylated red blood cell level 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...
Who cannot take part
- ✗Painful neuropathy other than DPN
- ✗History of heart dysrhythmias requiring anti-arrhythmia treatment(s)
- ✗History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months
- ✗Other protocol defined Inclusion/Exclusion criteria may apply.
See the full criteria
Where Is This Study? (9 UK sites)
Birmingham Heartlands Hospital - Heartlands Hospital Diabetes Centre and MIDRU
Birmingham, United Kingdom
FutureMeds Birmingham
Birmingham, United Kingdom
Ninewells Hospital - Endocrinology
Dundee, United Kingdom
FutureMeds Glasgow
Glasgow, United Kingdom
University of Liverpool - Aintree University Hospital
Liverpool, United Kingdom
St Pancras Clinical Research
London, United Kingdom
Manchester Diabetes Centre (MDC)
Manchester, United Kingdom
George Eliot Hospital NHS Trust
Nuneaton, United Kingdom
Royal Hallamshire Hospital - Endocrinology
Sheffield, United Kingdom
How to Get in Touch
Medical Information
Sponsor contactCONTACT