Evaluation of Efficacy and Safety of VX-548 for Painful Lumbosacral Radiculopathy (PLSR)
- Registration Number
- NCT06176196
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of the study is to evaluate the efficacy and safety of VX-548 in treating participants with PLSR.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 218
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VX-548 VX-548 Participants will receive VX-548 up to 12 weeks. Placebo Placebo Participants will receive placebo matched to VX-548 up to 12 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in the Weekly Average of Daily leg Pain Intensity on a Numeric Pain Rating Scale (NPRS) Baseline, Week 12
- Secondary Outcome Measures
Name Time Method Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS) Baseline, Week 12 Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Day 1 up to Week 14
Trial Locations
- Locations (54)
ARSN-Brain and Spine Institute
🇺🇸Port Orange, Florida, United States
Hope Research Institute
🇺🇸Phoenix, Arizona, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Trovare Clinical Research
🇺🇸Bakersfield, California, United States
Velocity Clinical Research - Banning
🇺🇸Banning, California, United States
Velocity Clinical Research - San Diego
🇺🇸La Mesa, California, United States
Probe Clinical Research
🇺🇸Riverside, California, United States
Pain Management and Injury Relief
🇺🇸Thousand Oaks, California, United States
Visionary Investigators Network
🇺🇸Aventura, Florida, United States
Nature Coast Clinical Research - Crystal River
🇺🇸Crystal River, Florida, United States
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