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

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Vertex Pharmaceuticals

Status and phase

Enrolling
Phase 2

Conditions

Painful Lumbosacral Radiculopathy

Treatments

Drug: VX-548
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06176196
VX23-548-109

Details and patient eligibility

About

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

Enrollment

200 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

200 participants in 2 patient groups, including a placebo group

VX-548
Experimental group
Description:
Participants will receive VX-548 up to 12 weeks.
Treatment:
Drug: VX-548
Placebo
Placebo Comparator group
Description:
Participants will receive placebo matched to VX-548 up to 12 weeks.
Treatment:
Drug: Placebo

Trial contacts and locations

54

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Central trial contact

Medical Information

Data sourced from clinicaltrials.gov

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