NCT06176196CompletedPhase 2
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-design Study of the Efficacy and Safety of VX-548 in Subjects With Painful Lumbosacral Radiculopathy
Vertex Pharmaceuticals Incorporated54 sites in 1 country218 target enrollmentStarted: December 13, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 218
- Locations
- 54
- Primary Endpoint
- Change From Baseline in the Weekly Average of Daily leg Pain Intensity on a Numeric Pain Rating Scale (NPRS)
Study Overview
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of VX-548 in treating participants with PLSR.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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.
Arms & Interventions
VX-548
Experimental
Participants will receive VX-548 up to 12 weeks.
Intervention: VX-548 (Drug)
Placebo
Placebo Comparator
Participants will receive placebo matched to VX-548 up to 12 weeks.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in the Weekly Average of Daily leg Pain Intensity on a Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline, Week 12
Secondary Outcomes
- 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)
Investigators
Study Sites (54)
Loading locations...
Similar Trials
Completed
Phase 2
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After a BunionectomyAcute PainNCT04977336Vertex Pharmaceuticals Incorporated274
Completed
Phase 2
A Study Evaluating Efficacy and Safety of VX-548 for Acute Pain After an AbdominoplastyAcute PainNCT05034952Vertex Pharmaceuticals Incorporated303
Completed
Phase 2
Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)Diabetic Peripheral NeuropathyNCT05660538Vertex Pharmaceuticals Incorporated194
Completed
Phase 3
Evaluation of Efficacy and Safety of Suzetrigine for Acute Pain After an AbdominoplastyAcute PainNCT05558410Vertex Pharmaceuticals Incorporated1,118
Terminated
Phase 2
A Study to Evaluate the Efficacy and Safety of VX-765 in Subjects With Treatment-Resistant Partial EpilepsyEpilepsyNCT01501383Vertex Pharmaceuticals Incorporated55