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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Trigeminal Neuralgia

Intervention / Treatment
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* Drug: Oxtellar XR 150Mg Extended Release Tablet


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>This arm includes subjects who have been prescribed Oxtellar XR 150Mg Extended Release Tablets. | Drug: Oxtellar XR 150Mg Extended Release Tablet<br>* Oxtellar XR<br>* Other names: Oxtellar XR 600Mg Extended Release Tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain associated with trigeminal neuralgia (BPI) | Pain associated with trigeminal neuralgia as measured by the Brief Pain Inventory (BPI) facial. | Weeks 2, 6, and 10 following screening | 
| Change in pain associated with trigeminal neuralgia (VAS) | Pain associated with trigeminal neuralgia as measured by a Visiual Analog Scale (VAS). | Weeks 2, 6, and 10 following screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | The Subjects Quality of life will be evaluated based on the their responses to the following endpoint: treatment satisfaction QOL questionnaire | Weeks 2, 6, and 10 following screening | 
| Change in Safety: Number of Attacks | The subjects Safety profile will be measured based upon the number of attacks experienced. | Weeks 2, 6, and 10 following screening | 
| Change in Safety: SF-12 Survey | The subjects Safety profile will be measured based upon completion of the SF-12 survey | Weeks 2, 6, and 10 following screening | 
| Change in Safety: Heart Rate | The subjects Safety profile will be measured based upon any noted changes in heart rate. | Weeks 2, 6, and 10 following screening | 
| Change in Safety: Blood Pressure | The subjects Safety profile will be measured based upon any noted changes in Blood pressure. | Weeks 2, 6, and 10 following screening | 
| Change in Safety: CBC | The subjects Safety profile will be measured based upon a complete blood count (CBC). | Weeks 2, 6, and 10 following screening | 
| Change in Safety: CMP | The subjects Safety profile will be measured based upon a Comprehensive Metabolic Panel (CMP). | Weeks 2, 6, and 10 following screening | 
| Change in Treatment Satisfaction | Treatment satisfaction will be measured through the completion of the Treatment Satisfaction Questionnaire For Medication (TSQM). | Weeks 2, 6, and 10 following screening | 
| Change in Tolerability: Number of Attacks | Change in Tolerability will be measured by the number of attacks. | Weeks 2, 6, and 10 following screening | 
| Change in Tolerability: SF-12 Survey | Change in Tolerability will be measured by the completion of the SF-12 survey. | Weeks 2, 6, and 10 following screening | 
| Change in Tolerability: Vital Signs | Change in Tolerability will be measured by vital signs. | Weeks 2, 6, and 10 following screening | 
| Change in Tolerability: CBC | Change in Tolerability will be measured by a complete blood count (CBC). | Weeks 2, 6, and 10 following screening | 
| Change in Tolerability: CMP | Change in Tolerability will be measured by a comprehensive metabolic panel (CMP). | Weeks 2, 6, and 10 following screening | 
| Change in Tolerability: TSQM | Change in Tolerability will be measured by the completion of the Treatment Satisfaction Questionnaire For Medication (TSQM). | Weeks 2, 6, and 10 following screening |