Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)
Sponsored by Vertex Pharmaceuticals Incorporated
About this trial
Last updated 2 years ago
Study ID
VX21-548-103
Status
Active, not recruiting
Type
Interventional
Phase
Phase 2
Placebo
No
Accepting
18 to 80 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended a year ago
What is this trial about?
The purpose of this study is to evaluate the efficacy and safety of VX-548 doses in treating
Painful DPN.
What are the Participation Requirements?
Key Inclusion Criteria:
- Diagnosis of diabetes mellitus type 1 or type 2 with
- Glycosylated hemoglobin A1c (HbA1c) ≤9%; and
- Presence of bilateral pain in lower extremities due to DPN for at least 1 year
Key Exclusion Criteria:
- Painful neuropathy other than DPN
- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
- History of a clinical atherosclerotic event, such as myocardial infarction or stroke,
within the past 12 months
Other protocol defined Inclusion/Exclusion criteria may apply.