Pilot Study of Oxtellar XR (Oxcarbazepine Extended Release) in Neurology Patients With Trigeminal Neuralgia
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Primary Endpoint
- Change in pain associated with trigeminal neuralgia (BPI)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Treatment Group
This arm includes subjects who have been prescribed Oxtellar XR 150Mg Extended Release Tablets.
Intervention: Oxtellar XR 150Mg Extended Release Tablet (Drug)
Outcomes
Primary Outcomes
Change in pain associated with trigeminal neuralgia (BPI)
Time Frame: Weeks 2, 6, and 10 following screening
Pain associated with trigeminal neuralgia as measured by the Brief Pain Inventory (BPI) facial.
Change in pain associated with trigeminal neuralgia (VAS)
Time Frame: Weeks 2, 6, and 10 following screening
Pain associated with trigeminal neuralgia as measured by a Visiual Analog Scale (VAS).
Secondary Outcomes
- Change in Quality of Life(Weeks 2, 6, and 10 following screening)
- Change in Safety: Number of Attacks(Weeks 2, 6, and 10 following screening)
- Change in Safety: SF-12 Survey(Weeks 2, 6, and 10 following screening)
- Change in Safety: Heart Rate(Weeks 2, 6, and 10 following screening)
- Change in Safety: Blood Pressure(Weeks 2, 6, and 10 following screening)
- Change in Safety: CBC(Weeks 2, 6, and 10 following screening)
- Change in Safety: CMP(Weeks 2, 6, and 10 following screening)
- Change in Treatment Satisfaction(Weeks 2, 6, and 10 following screening)
- Change in Tolerability: Number of Attacks(Weeks 2, 6, and 10 following screening)
- Change in Tolerability: SF-12 Survey(Weeks 2, 6, and 10 following screening)
- Change in Tolerability: Vital Signs(Weeks 2, 6, and 10 following screening)
- Change in Tolerability: CBC(Weeks 2, 6, and 10 following screening)
- Change in Tolerability: CMP(Weeks 2, 6, and 10 following screening)
- Change in Tolerability: TSQM(Weeks 2, 6, and 10 following screening)