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

NCT03374709 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 17-1398
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Change in Quality of Life

  Weeks 2, 6, and 10 following screening

• Change in Safety: Number of Attacks

  Weeks 2, 6, and 10 following screening

• Change in Safety: SF-12 Survey

  Weeks 2, 6, and 10 following screening

• Change in Safety: Heart Rate

  Weeks 2, 6, and 10 following screening

• Change in Safety: Blood Pressure

  Weeks 2, 6, and 10 following screening

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Drug: Oxtellar XR 150Mg Extended Release Tablet

Interventions

Oxtellar XR 150Mg Extended Release Tablet DRUG

Oxtellar XR

Also known as: Oxtellar XR 300Mg Extended Release Tablet, Oxtellar XR 600Mg Extended Release Tablet

Treatment Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Related Publications (8)

• 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

  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.

  PMID: 27306631 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.

  PMID: 18721143 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.

  PMID: 22588748 BACKGROUND

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

  PMID: 21280505 BACKGROUND

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

  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.

  PMID: 25361481 BACKGROUND

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Oxcarbazepine

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Carbamazepine; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jacquelyn Bainbridge, PharmD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: December 15, 2017
• Study Start: December 14, 2018
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: November 1, 2019

Record last verified: 2019-10