Painful Lumbosacral Radiculopathy
Conditions
Brief summary
The purpose of the study is to evaluate the efficacy and safety of VX-548 in treating participants with PLSR.
Interventions
DRUGVX-548
Tablets for oral administration.
DRUGPlacebo
Tablets for oral administration.
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in the Weekly Average of Daily leg Pain Intensity on a Numeric Pain Rating Scale (NPRS) | Baseline, Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed