Trigeminal Neuralgia
Conditions
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.
Interventions
DRUGOxtellar XR 150Mg Extended Release Tablet
Oxtellar XR
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain associated with trigeminal neuralgia (BPI) | 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) | Weeks 2, 6, and 10 following screening | Pain associated with trigeminal neuralgia as measured by a Visiual Analog Scale (VAS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Safety: Number of Attacks | Weeks 2, 6, and 10 following screening | The subjects Safety profile will be measured based upon the number of attacks experienced. |
| Change in Safety: Heart Rate | Weeks 2, 6, and 10 following screening | The subjects Safety profile will be measured based upon any noted changes in heart rate. |
| Change in Safety: Blood Pressure | Weeks 2, 6, and 10 following screening | The subjects Safety profile will be measured based upon any noted changes in Blood pressure. |
| Change in Safety: CBC | Weeks 2, 6, and 10 following screening | The subjects Safety profile will be measured based upon a complete blood count (CBC). |
| Change in Safety: CMP | Weeks 2, 6, and 10 following screening | The subjects Safety profile will be measured based upon a Comprehensive Metabolic Panel (CMP). |
| Change in Treatment Satisfaction | Weeks 2, 6, and 10 following screening | Treatment satisfaction will be measured through the completion of the Treatment Satisfaction Questionnaire For Medication (TSQM). |
| Change in Safety: SF-12 Survey | Weeks 2, 6, and 10 following screening | The subjects Safety profile will be measured based upon completion of the SF-12 survey |
| Change in Tolerability: SF-12 Survey | Weeks 2, 6, and 10 following screening | Change in Tolerability will be measured by the completion of the SF-12 survey. |
| Change in Tolerability: Vital Signs | Weeks 2, 6, and 10 following screening | Change in Tolerability will be measured by vital signs. |
| Change in Tolerability: CBC | Weeks 2, 6, and 10 following screening | Change in Tolerability will be measured by a complete blood count (CBC). |
| Change in Tolerability: CMP | Weeks 2, 6, and 10 following screening | Change in Tolerability will be measured by a comprehensive metabolic panel (CMP). |
| Change in Tolerability: TSQM | Weeks 2, 6, and 10 following screening | Change in Tolerability will be measured by the completion of the Treatment Satisfaction Questionnaire For Medication (TSQM). |
| Change in Tolerability: Number of Attacks | Weeks 2, 6, and 10 following screening | Change in Tolerability will be measured by the number of attacks. |
| Change in Quality of Life | Weeks 2, 6, and 10 following screening | The Subjects Quality of life will be evaluated based on the their responses to the following endpoint: treatment satisfaction QOL questionnaire |
Outcome results
None listed