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Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy
EU CTIS ID: 2024-514689-38-01
What this study is testing
To evaluate the efficacy of VX-993 doses in treating subjects with pain associated with diabetic peripheral neuropathy (DPN) To evaluate the safety and tolerability of VX-993
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of diabetes mellitus type 1 or type 2 with o glycosylated hemoglobin A1c (HbA1c) ≤9%; o in the opinion of the investigator, optimized glycemic control, and subject has been stable on anti-diabetic medicine/drugs or dietary treatment for ≥3 months before Screening Visit 1; and o 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.
You likely can't join if
- Painful neuropathy other than DPN, such as post-herpetic neuralgia, post-traumatic nerve injury, diabetic amyotrophy, human immunodeficiency virus (HIV) neuropathy, immune sensory and autonomic polyneuropathy (e.g., Sjogren’s syndrome), hereditary sensory and autonomic polyneuropathy, focal diabetic neuropathies (e.g., proximal motor neuropathy, mononeuropathy, mononeuropathy multiplex), or chronic regional pain syndrome. Previously diagnosed compressive neuropathy (e.g., carpal tunnel syndrome) with symptoms limited to upper extremities that is now resolved is not exclusionary
- Cardiac dysrhythmias requiring anti-arrhythmic treatment(s) within the last 2 years; history or evidence of abnormal study ECGs that in the opinion of the investigator or medical monitor would preclude the subject’s participation in the study; or history of QT prolongation or standard 12-lead ECG (performed in triplicate) demonstrating median QTcF >450 msec at Screening Visit 1; or clinical evidence of structural heart disease.
- History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months before Screening Visit 1.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.