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Resource and time constraints were encountered by product manufacturer and study team.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | This arm includes subjects who have been prescribed Oxtellar XR 150Mg Extended Release Tablets. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxtellar XR 150Mg Extended Release Tablet | Drug | Oxtellar XR |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacquelyn Bainbridge, PharmD | University of Colorado, Denver | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Available at: http://trigeminalneuralgia-ronaldbrismanmd.com/Trigeminal-Neuralgia-MS.html. Accessed December 12, 2016. | ||
| Background | Available at: http://fpa-support.org/tn-and-ms-2/. Accessed December 12, 2016 | ||
| 27306631 | Background | Cruccu G, Finnerup NB, Jensen TS, Scholz J, Sindou M, Svensson P, Treede RD, Zakrzewska JM, Nurmikko T. Trigeminal neuralgia: New classification and diagnostic grading for practice and research. Neurology. 2016 Jul 12;87(2):220-8. doi: 10.1212/WNL.0000000000002840. Epub 2016 Jun 15. | |
| 18721143 |
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D000078330 | Oxcarbazepine |
| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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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 |
| Background |
| Cruccu G, Gronseth G, Alksne J, Argoff C, Brainin M, Burchiel K, Nurmikko T, Zakrzewska JM; American Academy of Neurology Society; European Federation of Neurological Society. AAN-EFNS guidelines on trigeminal neuralgia management. Eur J Neurol. 2008 Oct;15(10):1013-28. doi: 10.1111/j.1468-1331.2008.02185.x. Epub 2008 Aug 21. |
| 22588748 | Background | Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available. |
| 21280505 | Background | Chen HI, Lee JY. The measurement of pain in patients with trigeminal neuralgia. Clin Neurosurg. 2010;57:129-33. No abstract available. |
| Background | Available at: http://www.quintiles.com/landing-pages/treatment-satisfaction-questionnaire-for-medication-tsqm. Accessed December 12, 2016 |
| 25361481 | Background | Sandhu SK, Halpern CH, Vakhshori V, Mirsaeedi-Farahani K, Farrar JT, Lee JY. Brief pain inventory--facial minimum clinically important difference. J Neurosurg. 2015 Jan;122(1):180-90. doi: 10.3171/2014.8.JNS132547. |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D006571 | Heterocyclic Compounds |