Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy
Part of paid clinical trials in Anniston, Alabama.
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Study ID
- NCT06628908
- 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.
- Pregabalin — DRUGCapsules for oral administration.
- Placebo (matched to Pregabalin) — DRUGPlacebo matched to Pregabalin for oral administration.
Study Details
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).
Key Dates
- Start date
- Oct 1, 2024
- Status verified
- Sep 2025
- Primary completion
- May 31, 2027
- Completion
- May 31, 2027
Study Design
- Enrollment
- 1,100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Suzetrigine (SUZ)Participants will be randomized to receive SUZ.
- Active Comparator: PregabalinParticipants will be randomized to receive Pregabalin.
- Placebo Comparator: PlaceboParticipants will be randomized to receive placebo matched to SUZ and Pregabalin.
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 Information617-341-6777
Locations (76)
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