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

Primary Purpose

Trigeminal Neuralgia

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Oxtellar XR 150Mg Extended Release Tablet
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigeminal Neuralgia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment Group

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Change in pain associated with trigeminal neuralgia (BPI)
    Pain associated with trigeminal neuralgia as measured by the Brief Pain Inventory (BPI) facial.
    Change in pain associated with trigeminal neuralgia (VAS)
    Pain associated with trigeminal neuralgia as measured by a Visiual Analog Scale (VAS).

    Secondary Outcome Measures

    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
    Change in Safety: Number of Attacks
    The subjects Safety profile will be measured based upon the number of attacks experienced.
    Change in Safety: SF-12 Survey
    The subjects Safety profile will be measured based upon completion of the SF-12 survey
    Change in Safety: Heart Rate
    The subjects Safety profile will be measured based upon any noted changes in heart rate.
    Change in Safety: Blood Pressure
    The subjects Safety profile will be measured based upon any noted changes in Blood pressure.
    Change in Safety: CBC
    The subjects Safety profile will be measured based upon a complete blood count (CBC).
    Change in Safety: CMP
    The subjects Safety profile will be measured based upon a Comprehensive Metabolic Panel (CMP).
    Change in Treatment Satisfaction
    Treatment satisfaction will be measured through the completion of the Treatment Satisfaction Questionnaire For Medication (TSQM).
    Change in Tolerability: Number of Attacks
    Change in Tolerability will be measured by the number of attacks.
    Change in Tolerability: SF-12 Survey
    Change in Tolerability will be measured by the completion of the SF-12 survey.
    Change in Tolerability: Vital Signs
    Change in Tolerability will be measured by vital signs.
    Change in Tolerability: CBC
    Change in Tolerability will be measured by a complete blood count (CBC).
    Change in Tolerability: CMP
    Change in Tolerability will be measured by a comprehensive metabolic panel (CMP).
    Change in Tolerability: TSQM
    Change in Tolerability will be measured by the completion of the Treatment Satisfaction Questionnaire For Medication (TSQM).

    Full Information

    First Posted
    August 9, 2017
    Last Updated
    October 30, 2019
    Sponsor
    University of Colorado, Denver
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03374709
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Resource and time constraints were encountered by product manufacturer and study team.
    Study Start Date
    December 14, 2018 (Actual)
    Primary Completion Date
    December 14, 2018 (Actual)
    Study Completion Date
    December 14, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver

    4. Oversight

    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

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Trigeminal Neuralgia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Group
    Arm Type
    Experimental
    Arm Description
    This arm includes subjects who have been prescribed Oxtellar XR 150Mg Extended Release Tablets.
    Intervention Type
    Drug
    Intervention Name(s)
    Oxtellar XR 150Mg Extended Release Tablet
    Other Intervention Name(s)
    Oxtellar XR 300Mg Extended Release Tablet, Oxtellar XR 600Mg Extended Release Tablet
    Intervention Description
    Oxtellar XR
    Primary Outcome Measure Information:
    Title
    Change in pain associated with trigeminal neuralgia (BPI)
    Description
    Pain associated with trigeminal neuralgia as measured by the Brief Pain Inventory (BPI) facial.
    Time Frame
    Weeks 2, 6, and 10 following screening
    Title
    Change in pain associated with trigeminal neuralgia (VAS)
    Description
    Pain associated with trigeminal neuralgia as measured by a Visiual Analog Scale (VAS).
    Time Frame
    Weeks 2, 6, and 10 following screening
    Secondary Outcome Measure Information:
    Title
    Change in Quality of Life
    Description
    The Subjects Quality of life will be evaluated based on the their responses to the following endpoint: treatment satisfaction QOL questionnaire
    Time Frame
    Weeks 2, 6, and 10 following screening
    Title
    Change in Safety: Number of Attacks
    Description
    The subjects Safety profile will be measured based upon the number of attacks experienced.
    Time Frame
    Weeks 2, 6, and 10 following screening
    Title
    Change in Safety: SF-12 Survey
    Description
    The subjects Safety profile will be measured based upon completion of the SF-12 survey
    Time Frame
    Weeks 2, 6, and 10 following screening
    Title
    Change in Safety: Heart Rate
    Description
    The subjects Safety profile will be measured based upon any noted changes in heart rate.
    Time Frame
    Weeks 2, 6, and 10 following screening
    Title
    Change in Safety: Blood Pressure
    Description
    The subjects Safety profile will be measured based upon any noted changes in Blood pressure.
    Time Frame
    Weeks 2, 6, and 10 following screening
    Title
    Change in Safety: CBC
    Description
    The subjects Safety profile will be measured based upon a complete blood count (CBC).
    Time Frame
    Weeks 2, 6, and 10 following screening
    Title
    Change in Safety: CMP
    Description
    The subjects Safety profile will be measured based upon a Comprehensive Metabolic Panel (CMP).
    Time Frame
    Weeks 2, 6, and 10 following screening
    Title
    Change in Treatment Satisfaction
    Description
    Treatment satisfaction will be measured through the completion of the Treatment Satisfaction Questionnaire For Medication (TSQM).
    Time Frame
    Weeks 2, 6, and 10 following screening
    Title
    Change in Tolerability: Number of Attacks
    Description
    Change in Tolerability will be measured by the number of attacks.
    Time Frame
    Weeks 2, 6, and 10 following screening
    Title
    Change in Tolerability: SF-12 Survey
    Description
    Change in Tolerability will be measured by the completion of the SF-12 survey.
    Time Frame
    Weeks 2, 6, and 10 following screening
    Title
    Change in Tolerability: Vital Signs
    Description
    Change in Tolerability will be measured by vital signs.
    Time Frame
    Weeks 2, 6, and 10 following screening
    Title
    Change in Tolerability: CBC
    Description
    Change in Tolerability will be measured by a complete blood count (CBC).
    Time Frame
    Weeks 2, 6, and 10 following screening
    Title
    Change in Tolerability: CMP
    Description
    Change in Tolerability will be measured by a comprehensive metabolic panel (CMP).
    Time Frame
    Weeks 2, 6, and 10 following screening
    Title
    Change in Tolerability: TSQM
    Description
    Change in Tolerability will be measured by the completion of the Treatment Satisfaction Questionnaire For Medication (TSQM).
    Time Frame
    Weeks 2, 6, and 10 following screening

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jacquelyn Bainbridge, PharmD
    Organizational Affiliation
    University of Colorado, Denver
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    Citation
    Available at: http://trigeminalneuralgia-ronaldbrismanmd.com/Trigeminal-Neuralgia-MS.html. Accessed December 12, 2016.
    Results Reference
    background
    Citation
    Available at: http://fpa-support.org/tn-and-ms-2/. Accessed December 12, 2016
    Results Reference
    background
    PubMed Identifier
    27306631
    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.
    Results Reference
    background
    PubMed Identifier
    18721143
    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.
    Results Reference
    background
    PubMed Identifier
    22588748
    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.
    Results Reference
    background
    PubMed Identifier
    21280505
    Citation
    Chen HI, Lee JY. The measurement of pain in patients with trigeminal neuralgia. Clin Neurosurg. 2010;57:129-33. No abstract available.
    Results Reference
    background
    Citation
    Available at: http://www.quintiles.com/landing-pages/treatment-satisfaction-questionnaire-for-medication-tsqm. Accessed December 12, 2016
    Results Reference
    background
    PubMed Identifier
    25361481
    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.
    Results Reference
    background

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

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