Clinical trial NCT06176196: Evaluation of Efficacy and Safety of VX-548 for Painful Lumbosacral Radiculopathy (PLSR)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Painful Lumbosacral Radiculopathy
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2023-12-19
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy and safety of VX-548 in treating participants with PLSR.


Eligibility 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/Exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in the Weekly Average of Daily leg Pain Intensity on a Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS)
timeFrame: Baseline, Week 12
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Week 14
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Bakersfield
country: United States
facility: Trovare Clinical Research
state: California
city: Banning
country: United States
facility: Velocity Clinical Research - Banning
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research - San Diego
state: California
city: Riverside
country: United States
facility: Probe Clinical Research
state: California
city: Thousand Oaks
country: United States
facility: Pain Management and Injury Relief
state: California
city: Aventura
country: United States
facility: Visionary Investigators Network
state: Florida
city: Crystal River
country: United States
facility: Nature Coast Clinical Research - Crystal River
state: Florida
city: Cutler Bay
country: United States
facility: JY Research Institute
state: Florida
city: Fleming Island
country: United States
facility: Fleming Island Center for Clinical Research
state: Florida
city: Hialeah
country: United States
facility: Convenient Medical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: L&C Professional Medical Research Institute
state: Florida
city: Miami
country: United States
facility: Medical Research of Westchester
state: Florida
city: Port Orange
country: United States
facility: ARSN-Brain and Spine Institute
state: Florida
city: Seminole
country: United States
facility: Accel Research Site - St. Petersburg/Largo
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Columbus
country: United States
facility: ClinCept Clinical Research
state: Georgia
city: Decatur
country: United States
facility: Accel Research Sites - Neurostudies
state: Georgia
city: Savannah
country: United States
facility: Velocity Clinical Research - Savannah Neurology Specialists
state: Georgia
city: Savannah
country: United States
facility: Velocity Clinical Research - Savannah
state: Georgia
city: Stockbridge
country: United States
facility: Center for Pain Management and Rehab
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise
state: Idaho
city: Flossmoor
country: United States
facility: Healthcare Research Network II, LLC
state: Illinois
city: Palos Hills
country: United States
facility: Essential Concepts Research Solutions
state: Illinois
city: Wichita
country: United States
facility: AMR Wichita East, KS
state: Kansas
city: Rockville
country: United States
facility: Velocity Clinical Research - Rockville
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital (BWH)
state: Massachusetts
city: Waltham
country: United States
facility: MedVadis Research Coorporation
state: Massachusetts
city: Chesterfield
country: United States
facility: St. Louis Pain Consultants
state: Missouri
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: Lincoln
country: United States
facility: Be Well Clinical Studies, LLC
state: Nebraska
city: Henderson
country: United States
facility: Synexus Clinical Research - Henderson
state: Nevada
city: Las Vegas
country: United States
facility: AMR Las Vegas (Clinical Research Consortium)
state: Nevada
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: AES New York
state: New York
city: Cincinnati
country: United States
facility: Velocity Clinical Research - Cincinnati
state: Ohio
city: Dayton
country: United States
facility: META Medical Research Institute
state: Ohio
city: Lima
country: United States
facility: NexGen Research
state: Ohio
city: Edmond
country: United States
facility: Clinical Investigations LLC.
state: Oklahoma
city: Norman
country: United States
facility: AMR Norman
state: Oklahoma
city: Eugene
country: United States
facility: Pacific Sports and Spine
state: Oregon
city: Grants Pass
country: United States
facility: Velocity Clinical Research - Grants Pass
state: Oregon
city: East Greenwich
country: United States
facility: Velocity Clinical Research - Providence
state: Rhode Island
city: Charleston
country: United States
facility: Clinical Trials of South Carolina - Charleston
state: South Carolina
city: Dallas
country: United States
facility: AES Dallas Forth Worth
state: Texas
city: Houston
country: United States
facility: Expert Pain
state: Texas
city: Lubbock
country: United States
facility: Lubbock Spine Institute
state: Texas
city: Round Rock
country: United States
facility: Be Well Clinical Studies - Austin
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
city: Hampton
country: United States
facility: Velocity Clinical Research - Hampton
state: Virginia
city: Norfolk
country: United States
facility: AMR Norfolk
state: Virginia
city: Portsmouth
country: United States
facility: Velocity Clinical Research - Portsmouth
state: Virginia
Study officials:
References: