Clinical Trial 56164

Lincoln, NE 68516


<b>Painful Lumbosacral Radiculopathy (PLSR) - Multiple Locations in the US</b>

Study Summary:
If you experience chronic nerve pain in your leg, you may have a condition known as painful lumbosacral radiculopathy (PLSR), commonly known as sciatica. The NAVIGATOR-2 Study is a clinical research study for individuals 18 to 70 years of age (inclusive) with PLSR.

Study Purpose:
The purpose of the NAVIGATOR-2 Study is to evaluate the safety and effectiveness of an investigational drug in individuals with painful lumbosacral radiculopathy (PLSR). The word “investigational” means this medication is not yet approved for use by the Food and Drug Administration (FDA) in the United States or other regulatory agencies in Canada, Europe, or elsewhere.

The investigational drug, called VX-548, is designed to target a sodium channel in the body called NaV1.8. Researchers are evaluating if targeting and inhibiting this sodium channel treats pain from PLSR. Participants in this study will be selected at random to receive either the investigational drug or a placebo (a substance that looks just like the investigational drug but does not contain any medication in it). The assigned study treatment will be taken as three oral tablets in the morning every day. Neither the participant nor the study doctor will know if the participant has been assigned to the investigational drug or the placebo, but in case of an emergency, the study doctor can quickly find out.

Participation will last approximately 19 weeks.

Compensation for study-related time as well as reimbursement for travel may be available.

Eligibility Criteria:
Eligible participants must:

  • Be between the ages of 18 and 70 (inclusive)
  • Have had symptoms of sciatica for more than 3 months
  • Have pain in one leg, with leg pain worse than back pain

There are additional eligibility requirements, which the study doctor can explain to you.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.