Diabetic Peripheral Neuropathic Pain
Conditions
Brief summary
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).
Interventions
DRUGSuzetrigine
Tablets for oral administration
Placebo matched to SUZ for oral administration.
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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 pain in lower extremities due to DPN for at least 1 year * 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 * Received Journavx within 30 days of study drug dosing * Any sensory abnormality (excluding DPN) as pre-specified in the protocol Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in the Weekly Average of Daily Pain Intensity on the Numeric Pain Rating Scale (NPRS) at Week 12 Compared to Placebo | From Baseline up to Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| 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 VX24-548-110) | From Baseline up to Week 12 |
Countries
United States
Contacts
CONTACTMedical Information
Outcome results
None listed