Summary:
A clinical research study for individuals 18 to 80 (inclusive) years of age with painful diabetic peripheral neuropathy (DPN).
The purpose of the NAVIGATOR Study is to evaluate the safety and effectiveness of an investigational drug in patients with chronic nerve pain from diabetic peripheral neuropathy (DPN). 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 DPN. The investigational drug is being compared to a currently approved medication for management of DPN. Participants will be selected at random to receive either the currently approved medication or a low, mid, or high dose of the investigational drug. Participants will take their assigned study treatment as follows: three tablets in the morning and one capsule three times a day (three capsules per day total). Neither the participant nor the study doctor will know what the participant has been assigned to receive, but in case of an emergency, the study doctor can quickly find out.
Participation will last approximately 19 weeks.
Eligible participants must:
- Be between the ages of 18 and 80 (inclusive)
- Have a diagnosis of type 1 or type 2 diabetes mellitus
- Have pain in both lower extremities due to DPN for at least one year
There are additional eligibility requirements, which the study doctor can explain to you.