Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Study ID
- NCT07231419
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Diabetic Peripheral Neuropathic Pain
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Suzetrigine — DRUGTablets for oral administration
- Placebo (matched to SUZ) — DRUGPlacebo matched to SUZ for oral administration.
Study Details
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).
Key Dates
- Start date
- Nov 21, 2025
- Status verified
- Nov 2025
- Primary completion
- Apr 6, 2027
- Completion
- Apr 6, 2027
Study Design
- Enrollment
- 734 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Suzetrigine (SUZ)Participants will be randomized to receive SUZ.
- Placebo Comparator: PlaceboParticipants will be randomized to receive placebo matched to SUZ.
Primary Outcome Measure
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 ]
Central Contacts
- Medical Information6173416777
Locations (75)
Find similar trials in Birmingham, AL
Related Studies
- MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNPPHASE1 · Recruiting · Zhejiang Hanmai Pharmaceutical Technology Co., Ltd. · Fredericksburg, Texas
- Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral NeuropathyPHASE2 · Recruiting · Vertex Pharmaceuticals Incorporated · Cullman, Alabama
- Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral NeuropathyPHASE3 · Recruiting · Vertex Pharmaceuticals Incorporated · Anniston, Alabama
- A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic PainPHASE2 · Recruiting · Eli Lilly and Company · Birmingham, Alabama