Diabetic Peripheral Neuropathic Pain
Conditions
Brief summary
The purpose of this study is to evaluate the long-term safety and tolerability of SUZ and long-term effectiveness of SUZ in treating pain associated with DPN.
Interventions
DRUGSuzetrigine
Tablets for oral administration.
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: • Completed the final visit in the Treatment Period (i.e., Week 12) and subsequent 7-day period (to allow for taper of blinded capsule study drug) in a parent study such as VX24-548-110 or VX24-548-111 Key
Exclusion criteria
* Any sensory abnormality (excluding DPN) * History of drug intolerance in a parent study that would pose an additional risk to the participant in the opinion of the investigator * Current participation in an investigational drug trial (other than a parent study) Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Baseline up to Week 54 |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Study 36-item Short-form Health Status (SF-36v2) Physical Component Summary (PCS) Score | From Baseline up to Week 52 |
| Change From Baseline in the Short form McGill Pain Questionnaire-2 (SF-MPQ-2) Total Score | From Baseline up to Week 52 |
Countries
United States
Outcome results
None listed