Status:
COMPLETED
Evaluation of Efficacy and Safety of VX-548 for Painful Lumbosacral Radiculopathy (PLSR)
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Painful Lumbosacral Radiculopathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of VX-548 in treating participants with PLSR.
Eligibility Criteria
Inclusion
- Key
- Body weight greater than or equal to (\>=)45 kilogram (kg)
- Body mass index (BMI) less than or equal to (\<=) 40 kg/ meter square (m\^2)
- Diagnosis of PLSR for greater than (\>)3 months as per criteria pre-specified in the protocol
- Weekly average of daily NPRS score \>=4 and \<10 with limited variation in the 7-day Run-in Period
- Key
Exclusion
- More than 3 missing daily NPRS scores during the 7-day Run-in Period
- Moderate or severe painful neuropathy other than PLSR as pre-specified in the protocol
- History of prior lumbar spine surgery (e.g., discectomies, laminectomies, foraminotomies, or fusion)
- Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2024
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT06176196
Start Date
December 13 2023
End Date
October 16 2024
Last Update
October 1 2025
Active Locations (54)
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1
Hope Research Institute
Phoenix, Arizona, United States, 85018
2
Arizona Research Center
Phoenix, Arizona, United States, 85053
3
Trovare Clinical Research
Bakersfield, California, United States, 93301
4
Velocity Clinical Research - Banning
Banning, California, United States, 92220