Evaluation of Efficacy and Safety of VX-548 for Painful Lumbosacral Radiculopathy (PLSR) (NCT06176196) | Clinical Trial Compass
CompletedPhase 2
Evaluation of Efficacy and Safety of VX-548 for Painful Lumbosacral Radiculopathy (PLSR)
United States218 participantsStarted 2023-12-13
Plain-language summary
The purpose of the study is to evaluate the efficacy and safety of VX-548 in treating participants with PLSR.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Change From Baseline in the Weekly Average of Daily leg Pain Intensity on a Numeric Pain Rating Scale (NPRS)