NCT03374709

Oxtellar Extended Release (Oxcarbazepine Extended Release) Patients With Trigeminal Neuralgia

Pilot Study of Oxtellar XR (Oxcarbazepine Extended Release) in Neurology Patients With Trigeminal Neuralgia

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

To evaluate the affect Oxtellar XR (Extended Release) has on neurology patients with trigeminal neuralgia (TN), and if it impacts their quality of life.

Detailed description

Oxcarbazepine has been used off-label for TN for many years, but has a twice daily dosing. With the once daily dosing it should theoretically help with patient adherence and possibly decrease side effects, which is common with extended release formulations. Specifically the investigators are looking at how well tolerated Oxtellar XR is, and if it has the same efficacy as standard treatments. It is a pilot study, so it will be difficult to gather data and have powerful outcomes, but this will give pilot data for future trials. Patients will be screened for inclusion and exclusion criteria and after will participate in 3 visits following the initial one. Various tests will be administered to measure treatment satisfaction and tolerability throughout the visits. The patients will not have to pay for any of the study visits or medications. A parking voucher will be provided as needed.

Conditions

• Trigeminal Neuralgia

Interventions

Type	Name	Description
DRUG	Oxtellar XR 150Mg Extended Release Tablet	Oxtellar XR

Timeline

• Start date: 2018-12-14
• Primary completion: 2018-12-14
• Completion: 2018-12-14
• First posted: 2017-12-15
• Last updated: 2019-11-01

Regulatory

• FDA-regulated drug study