Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy
Research type
Research Study
Full title
A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of Oral VX-993 in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
IRAS ID
1010486
Contact name
Kristen Clare
Contact email
Sponsor organisation
Vertex Pharmaceuticals Incorporated
Clinicaltrials.gov Identifier
Research summary
This is a Phase 2 study which is being done to learn more about the safety and effectiveness of VX-993 in participants with pain due to Diabetic Peripheral Neuropathy (DPN), a type of nerve damage that is caused by high blood sugar (glucose) in diabetes.
Participants will be randomly assigned to 1 of 5 study treatment groups and will not know which group they are assigned to. They may be assigned to a standard of care group, meaning they will receive Pregabalin (a standard of care medicine for DPN) or the investigational drug VX-993. Regardless of which treatment group they are assigned to, all participants will take the same number of tablets and capsules per day for the treatment period.
The study includes a screening period that will last up to 5 weeks, including a 7 day run-in period, a 12-week study treatment period and a safety follow-up period that consists of 2 visits within 4 weeks.
Assessments include physical examinations, vital signs, electrocardiograms (ECGs), completion of questionnaires and a daily e-diary, and blood and urine sample collection for testing.
Approximately 300 participants, male and female aged 18 to 80 years old, will participate in this study globally. The sponsor of this trial is Vertex Pharmaceuticals Inc.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
24/SC/0312
Date of REC Opinion
24 Jan 2025
REC opinion
Further Information Favourable Opinion