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

University of Colorado Denver (CU Denver)

Status and phase: Withdrawn; Phase 4

Conditions: Trigeminal Neuralgia

Treatments: Drug: Oxtellar XR 150Mg Extended Release Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03374709

17-1398

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age > 18 to 75
• Subject reported history of trigeminal neuralgia average pain rated as > lower end of moderate 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 criteria

• Intolerance/Hypersensitivity to Trileptal, Oxcarbazepine, or Oxtellar
• Psychosis, drug/alcohol misuse, or malignancy (except skin cancer) within the last 2 years
• Any clinically significant medical condition that would prevent study from being completed 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 effective contraception (defined as double-barrier method)
• A severe pain condition, other than trigeminal neuralgia, which may impair the self-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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Treatment Group

Experimental group

Description:

This arm includes subjects who have been prescribed Oxtellar XR 150Mg Extended Release Tablets.

Treatment:

Drug: Oxtellar XR 150Mg Extended Release Tablet