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

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

To evaluate the affect Oxtellar XR (Extended Release) has on neurology patients with trigeminal neuralgia (TN), and if it impacts their quality of life.

Study Overview

• Status: Withdrawn
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Drug: Oxtellar XR 150Mg Extended Release Tablet

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.

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; This arm includes subjects who have been prescribed Oxtellar XR 150Mg Extended Release Tablets.	Drug: Oxtellar XR 150Mg Extended Release Tablet; Oxtellar XR; Other Names: Oxtellar XR 300Mg Extended Release Tablet; Oxtellar XR 600Mg Extended Release Tablet

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Jacquelyn Bainbridge, PharmD, University of Colorado, Denver

Publications and helpful links

General Publications

• 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.
• Available at: http://trigeminalneuralgia-ronaldbrismanmd.com/Trigeminal-Neuralgia-MS.html. Accessed December 12, 2016.
• Available at: http://fpa-support.org/tn-and-ms-2/. Accessed December 12, 2016
• 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.
• 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.
• Chen HI, Lee JY. The measurement of pain in patients with trigeminal neuralgia. Clin Neurosurg. 2010;57:129-33. No abstract available.
• Available at: http://www.quintiles.com/landing-pages/treatment-satisfaction-questionnaire-for-medication-tsqm. Accessed December 12, 2016
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2018
• Primary Completion (Actual): December 14, 2018
• Study Completion (Actual): December 14, 2018

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 15, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Trigeminal Neuralgia; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Oxcarbazepine
• Other Study ID Numbers: 17-1398

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes