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

Last updated: October 30, 2019
Sponsor: University of Colorado, Denver
Overall Status: Trial Not Available

Phase

4

Condition

Headaches

Pain

Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT03374709
17-1398
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18 to 75

  • Subject reported history of trigeminal neuralgia average pain rated as > lower end ofmoderate on the VAS

  • Trigeminal neuralgia diagnosis (Primary or type 1 or Idiopathic TN)

  • History of pain rated as at least a 4 on the visual analog scale (VAS)

  • Treatment naïve

  • Patients who do not tolerate carbamazepine

  • Women of reproductive age who agree to highly effective birth control

  • Complete Blood Count (CBC) 30 days prior to entering study

  • Comprehensive metabolic panel (CMP) 30 days prior to entering study

Exclusion

Exclusion Criteria:

  • Intolerance/Hypersensitivity to Trileptal, Oxcarbazepine, or Oxtellar

  • Psychosis, drug/alcohol misuse, or malignancy (except skin cancer) within the last 2years

  • Any clinically significant medical condition that would prevent study from beingcompleted safely (determined by subjects current neurologist)

  • Current seizure disorder or history of seizures

  • Pregnant females

  • Breastfeeding females

  • Women of reproductive age not using or unwilling to utilize highly effectivecontraception (defined as double-barrier method)

  • A severe pain condition, other than trigeminal neuralgia, which may impair theself-assessment of pain due to trigeminal neuralgia

  • Concurrent medication treatment with: Equetro, Phenytoin, Dilantin, Phenytek,Oxcarbazepine, Trileptal, Rifampin, Rifadin, Rimactane and St. John Wort

  • Renal impairment or hemodialysis

  • Hepatic impairment

  • History of hyponatremia (serum sodium < 125 ng/dL)

Study Design

Study Start date:
December 14, 2018
Estimated Completion Date:
December 14, 2018

Study 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.