Evaluating Suzetrigine for Pain from Diabetic Peripheral Neuropathy

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 Suzetrigine in individuals suffering from pain associated with diabetic peripheral neuropathy (DPN). Participants will be randomly assigned to receive either Suzetrigine, a placebo matched to Suzetrigine, Pregabalin, or a placebo matched to Pregabalin. The study will measure pain levels using a numerical pain rating scale (NPRS) and monitor for any adverse effects during the treatment period. The goal is to determine if Suzetrigine can provide significant pain relief compared to the placebo and standard treatment.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Body weight greater than or equal to (≥) 45 kilogram (kg)
* Body mass index (BMI) ≥18.0 to less than (\<) 40.0 kilogram per meter square (kg/m\^2)
* Diagnosis of diabetes mellitus type 1 or type 2 by glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN
* Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period

Key Exclusion Criteria:

* More than 3 missing daily NPRS scores during the 7-day Baseline Period
* Any sensory abnormality (excluding DPN) as pre-specified in the protocol

Other protocol defined Inclusion/Exclusion criteria may apply.

Where it's running

• Pinnacle Research Group, LLC
  Anniston, Alabama, United States Recruiting
• Scottsdale Clinical Trials
  Scottsdale, Arizona, United States Recruiting
• Neuro-Pain Medical Center
  Fresno, California, United States Recruiting
• Long Beach Research Institute
  Long Beach, California, United States Recruiting
• Angel City Research, Inc
  Los Angeles, California, United States Recruiting
• Empire Clinical Research
  Pomona, California, United States Recruiting

+26 more sites. See ClinicalTrials.gov for the full list.

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.

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

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  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 VX-993 for pain from diabetic nerve damage

  This study is testing if a new medication called VX-993 can help people with diabetes who have been dealing with pain in their legs and feet from nerve damage feel better compared to a standard treatment and a placebo.

  Recruiting at 22 sites Phase 2 Vertex Pharmaceuticals Incorporated · Cullman, Alabama and 46 other locations · NCT06619860

• Assessing a new spray treatment for diabetic nerve pain

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  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.