Clinical trial NCT03374709: Oxtellar Extended Release (Oxcarbazepine Extended Release) Patients With Trigeminal Neuralgia
Official title: Pilot Study of Oxtellar XR (Oxcarbazepine Extended Release) in Neurology Patients With Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Trigeminal Neuralgia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in pain associated with trigeminal neuralgia (BPI)
timeFrame: Weeks 2, 6, and 10 following screening
measure: Change in pain associated with trigeminal neuralgia (VAS)
timeFrame: Weeks 2, 6, and 10 following screening
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: Weeks 2, 6, and 10 following screening
measure: Change in Safety: Number of Attacks
timeFrame: Weeks 2, 6, and 10 following screening
measure: Change in Safety: SF-12 Survey
timeFrame: Weeks 2, 6, and 10 following screening
measure: Change in Safety: Heart Rate
timeFrame: Weeks 2, 6, and 10 following screening
measure: Change in Safety: Blood Pressure
timeFrame: Weeks 2, 6, and 10 following screening
measure: Change in Safety: CBC
timeFrame: Weeks 2, 6, and 10 following screening
measure: Change in Safety: CMP
timeFrame: Weeks 2, 6, and 10 following screening
measure: Change in Treatment Satisfaction
timeFrame: Weeks 2, 6, and 10 following screening
measure: Change in Tolerability: Number of Attacks
timeFrame: Weeks 2, 6, and 10 following screening
measure: Change in Tolerability: SF-12 Survey
timeFrame: Weeks 2, 6, and 10 following screening
measure: Change in Tolerability: Vital Signs
timeFrame: Weeks 2, 6, and 10 following screening
measure: Change in Tolerability: CBC
timeFrame: Weeks 2, 6, and 10 following screening
measure: Change in Tolerability: CMP
timeFrame: Weeks 2, 6, and 10 following screening
measure: Change in Tolerability: TSQM
timeFrame: Weeks 2, 6, and 10 following screening
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Jacquelyn Bainbridge, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Available at: http://fpa-support.org/tn-and-ms-2/. Accessed December 12, 2016
citation: 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.
citation: 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.
citation: 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.
citation: Chen HI, Lee JY. The measurement of pain in patients with trigeminal neuralgia. Clin Neurosurg. 2010;57:129-33. No abstract available.
citation: Available at: http://www.quintiles.com/landing-pages/treatment-satisfaction-questionnaire-for-medication-tsqm. Accessed December 12, 2016
citation: 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.