Pilot Study of Oxtellar XR (Oxcarbazepine Extended Release) in Neurology Patients With Trigeminal Neuralgia
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Change in pain associated with trigeminal neuralgia (BPI)
研究概览
简要总结
To evaluate the affect Oxtellar XR (Extended Release) has on neurology patients with trigeminal neuralgia (TN), and if it impacts their quality of life.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Treatment Group
This arm includes subjects who have been prescribed Oxtellar XR 150Mg Extended Release Tablets.
干预措施: Oxtellar XR 150Mg Extended Release Tablet (Drug)
结局指标
主要结局
Change in pain associated with trigeminal neuralgia (BPI)
时间窗: 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)
时间窗: Weeks 2, 6, and 10 following screening
Pain associated with trigeminal neuralgia as measured by a Visiual Analog Scale (VAS).
次要结局
- 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)