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Evaluation of Efficacy and Safety of VX-548 for Painful Lumbosacral Radiculopathy (PLSR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06176196
Recruitment Status : Recruiting
First Posted : December 19, 2023
Last Update Posted : March 7, 2024
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

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

Condition or disease Intervention/treatment Phase
Painful Lumbosacral Radiculopathy Drug: VX-548 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 13, 2023
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: VX-548
Participants will receive VX-548 up to 12 weeks.
 Drug: VX-548
Tablets for oral administration.
Placebo Comparator: Placebo
Participants will receive placebo matched to VX-548 up to 12 weeks.
 Drug: Placebo
Tablets for oral administration.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS) [ Time Frame: Baseline, Week 12 ]
  2. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From Day 1 up to Week 14 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06176196


Contacts
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Contact: Medical Information 617-341-6777 medicalinfo@vrtx.com

Locations
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Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
More Information
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Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT06176196    
Other Study ID Numbers: VX23-548-109
First Posted: December 19, 2023    Key Record Dates
Last Update Posted: March 7, 2024
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Radiculopathy
Pain
Neurologic Manifestations
 Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases