Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Suzetrigine, Placebo (matched to SUZ), Pregabalin, Placebo (matched to Pregabalin).
- Who it may be relevant to
- Registry conditions: Diabetic Peripheral Neuropathic Pain. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Randomized, Double-blind, Placebo- and Active-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
Overview
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).
Interventions
- Drug Suzetrigine
Tablets for oral administration. - Drug Placebo (matched to SUZ)
Placebo matched to SUZ for oral administration. - Drug Pregabalin
Capsules for oral administration. - Drug Placebo (matched to Pregabalin)
Placebo matched to Pregabalin for oral administration.
Primary outcome measures
- Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo [Time frame: From Baseline up to Week 12]
Secondary outcome measures (2)
- Change From Baseline in the Medical Outcomes Study 36-item Short-form Health Status (SF 36v2) Physical Component Summary (PCS) Score at Week 12 Compared to Placebo (pooled with data from Study VX24-548-111) [Time frame: From Baseline up to Week 12]
- Change From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS at Week 12 Compared to Pregabalin [Time frame: From Baseline up to Week 12]
Eligibility criteria
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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 76 centers
- Pinnacle Research Group, LLC — Anniston
- Synexus Clinical Research - Birmingham — Birmingham
- AMR Daphne, AL — Daphne
- Synexus Clinical Research - Phoenix Central — Phoenix
- Scottsdale Clinical Trials — Scottsdale
- Neuro-Pain Medical Center — Fresno
- Long Beach Research Institute — Long Beach
- Angel City Research, Inc — Los Angeles
- … and 68 more centers
Publications
- Fensterwald M, Johnson J, Moreno A, Conger-Love S, Flippen C, Hesterman C, Johnston M, Kamins J, Minota K, Pak P, Hashim S, Huynh-Tran TL, Kobayashi N, Shane B, Charles A, Nwaobi S. Suzetrigine as a novel treatment for headache disorders: A case series. Headache. 2026 Jul-Aug;66(7):1644-1649. doi: 10.1111/head.70147. Epub 2026 Jun 5. PMID 42249666
Identifiers
NCT: NCT06628908 · VX24-548-110