Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy
Recruiting
Phase 3
Interventional Study
Diabetic Peripheral Neuropathic Pain
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 734 (estimated)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
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About This Trial
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine in participants with pain associated with diabetic peripheral neuropathy (DPN).
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* Body weight greater than or equal to (≥)45 kilogram (kg)
* Body mass index (BMI) ≥18 to less than (\<) 40 kilogram per meter square (kg/m\^2)
* Diagnosis of diabetes mellitus type 1 or type 2 and with glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pa…
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