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

NCT ID: NCT03374709

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-14
• Study Completion Date: 2018-12-14

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.

Conditions

Trigeminal Neuralgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

This arm includes subjects who have been prescribed Oxtellar XR 150Mg Extended Release Tablets.

Group Type: EXPERIMENTAL

Oxtellar XR 150Mg Extended Release Tablet

Intervention Type: DRUG

Oxtellar XR

Interventions

Oxtellar XR 150Mg Extended Release Tablet

Oxtellar XR

Intervention Type: DRUG

Other Intervention Names

Oxtellar XR 300Mg Extended Release Tablet; Oxtellar XR 600Mg Extended Release Tablet

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacquelyn Bainbridge, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

References

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

Reference Type: BACKGROUND

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 27306631 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18721143 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22588748 (View on PubMed)

Chen HI, Lee JY. The measurement of pain in patients with trigeminal neuralgia. Clin Neurosurg. 2010;57:129-33. No abstract available.

Reference Type: BACKGROUND

PMID: 21280505 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 25361481 (View on PubMed)

Other Identifiers

17-1398

Identifier Type: -

Identifier Source: org_study_id