Evaluating VX-993 for pain from diabetic nerve damage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy, safety, and tolerability of VX-993 in individuals suffering from pain associated with Diabetic Peripheral Neuropathy (DPN). Participants will receive either VX-993, Pregabalin, or placebos matched to these treatments. The study will focus on patients diagnosed with diabetes who have experienced bilateral pain in their lower extremities due to DPN for at least one year. The trial is designed to determine how well VX-993 alleviates pain compared to existing treatments and placebos.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Diagnosis of diabetes mellitus type 1 or type 2 with

  * Glycosylated hemoglobin 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 sensorimotor polyneuropathy) for at least 1 year

Key Exclusion Criteria:

* Painful neuropathy other than DPN
* History of cardiac 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.

Where it's running

• Centricity Research Brampton
  Brampton, Canada Recruiting
• OCT Research ULC
  Kelowna, Canada Recruiting
• Altasciences - Beaumont Clinic Montreal
  Montreal, Canada Recruiting
• Mount Sinai Hospital - Leadership Sinai Centre for Diabetes (LSCD)
  Toronto, Canada Recruiting
• Centre Hospitalier Universitaire de Clermont-Ferrand - Site Gabriel-Montpied
  Clermont-Ferrand, France Recruiting
• CHU de Nîmes - Pain Assessment and Treatment Center
  Nîmes, France Recruiting

Study contacts

• Study coordinator: Medical Information
• Email: medicalinfo@vrtx.com
• Phone: 617-341-6777

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• HRS-2129 for diabetic peripheral neuropathic pain

  This trial will test whether HRS-2129 tablets reduce pain in adults with diabetic peripheral neuropathy compared with placebo.

  Recruiting at 2 sites Phase 1 Shandong Suncadia Medicine Co., Ltd. · Beijing, Beijing Municipality and 1 other locations · NCT07377721

• LY4065967 for diabetic peripheral neuropathic pain (part of a chronic pain master protocol)

  This trial tests whether LY4065967 can safely reduce pain in adults with diabetic peripheral neuropathic pain.

  Recruiting at 36 sites Phase 2 Eli Lilly and Company · Birmingham, Alabama and 35 other locations · NCT07285018

• Suzetrigine for pain from diabetic peripheral neuropathy

  This trial will test whether Suzetrigine reduces pain in adults with diabetic peripheral neuropathy.

  Recruiting at 70 sites Phase 3 Vertex Pharmaceuticals Incorporated · Birmingham, Alabama and 74 other locations · NCT07231419

• Evaluating Suzetrigine for Pain from Diabetic Peripheral Neuropathy

  This study is testing if a new medication called Suzetrigine can help people with diabetic nerve pain feel better compared to a placebo and a standard treatment.

  Recruiting at 58 sites Phase 3 Vertex Pharmaceuticals Incorporated · Anniston, Alabama and 75 other locations · NCT06628908

• Assessing a new spray treatment for diabetic nerve pain

  This study is testing a new spray treatment for diabetic nerve pain to see if it helps relieve pain and is safe for patients to use.

  Recruiting Phase 1 Zhejiang Hanmai Pharmaceutical Technology Co., Ltd. · Fredericksburg, Texas · NCT06361108

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.