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

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03374709
• Other study ID #: 17-1398
• Status: Withdrawn
• Phase: Phase 4
• Start date: December 14, 2018
• Est. completion date: December 14, 2018

Study information

• Verified date: October 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 14, 2018
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Drug:
• Oxtellar XR 150Mg Extended Release Tablet
Oxtellar XR

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

References & Publications (8)

Available at: http://fpa-support.org/tn-and-ms-2/. Accessed December 12, 2016

Available at: http://trigeminalneuralgia-ronaldbrismanmd.com/Trigeminal-Neuralgia-MS.html. Accessed December 12, 2016.

Available at: http://www.quintiles.com/landing-pages/treatment-satisfaction-questionnaire-for-medication-tsqm. Accessed December 12, 2016

Chen HI, Lee JY. The measurement of pain in patients with trigeminal neuralgia. Clin Neurosurg. 2010;57:129-33. Review. — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Tolerability: Number of Attacks	Change in Tolerability will be measured by the number of attacks.	Weeks 2, 6, and 10 following screening
Secondary	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
Secondary	Change in Tolerability: Vital Signs	Change in Tolerability will be measured by vital signs.	Weeks 2, 6, and 10 following screening
Secondary	Change in Tolerability: CBC	Change in Tolerability will be measured by a complete blood count (CBC).	Weeks 2, 6, and 10 following screening
Secondary	Change in Tolerability: CMP	Change in Tolerability will be measured by a comprehensive metabolic panel (CMP).	Weeks 2, 6, and 10 following screening
Secondary	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