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Trigeminal NeuralgiaPhase 4NCT03374709

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

A Phase 4 study testing Oxtellar XR 150Mg Extended Release Tablet in people with Trigeminal Neuralgia, run by University of Colorado, Denver.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Trigeminal Neuralgia
What is being tested?
Oxtellar XR 150Mg Extended Release Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
14 Dec 2018to 14 Dec 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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)

About this study

Official title: 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.

Read the 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.

Being tested
Oxtellar XR 150Mg Extended Release Tablet
Medical subject headings
Trigeminal Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxtellar XR 150Mg Extended Release TabletDrug

    Also called Oxtellar XR 300Mg Extended Release Tablet, Oxtellar XR 600Mg Extended Release Tablet

    Oxtellar XR

Study groups in NCT03374709
Study groupRoleWhat they receive
Treatment GroupExperimentalThis arm includes subjects who have been prescribed Oxtellar XR 150Mg Extended Release Tablets.
Receives: Drug: Oxtellar XR 150Mg Extended Release Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pain associated with trigeminal neuralgia (BPI)

    Pain associated with trigeminal neuralgia as measured by the Brief Pain Inventory (BPI) facial.

    Measured: Weeks 2, 6, and 10 following screening

  2. Change in pain associated with trigeminal neuralgia (VAS)

    Pain associated with trigeminal neuralgia as measured by a Visiual Analog Scale (VAS).

    Measured: Weeks 2, 6, and 10 following screening

Secondary outcomes (14)

  1. 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

    Measured: Weeks 2, 6, and 10 following screening

  2. Change in Safety: Number of Attacks

    The subjects Safety profile will be measured based upon the number of attacks experienced.

    Measured: Weeks 2, 6, and 10 following screening

  3. Change in Safety: SF-12 Survey

    The subjects Safety profile will be measured based upon completion of the SF-12 survey

    Measured: Weeks 2, 6, and 10 following screening

  4. Change in Safety: Heart Rate

    The subjects Safety profile will be measured based upon any noted changes in heart rate.

    Measured: Weeks 2, 6, and 10 following screening

  5. Change in Safety: Blood Pressure

    The subjects Safety profile will be measured based upon any noted changes in Blood pressure.

    Measured: Weeks 2, 6, and 10 following screening

  6. Change in Safety: CBC

    The subjects Safety profile will be measured based upon a complete blood count (CBC).

    Measured: Weeks 2, 6, and 10 following screening

  7. Change in Safety: CMP

    The subjects Safety profile will be measured based upon a Comprehensive Metabolic Panel (CMP).

    Measured: Weeks 2, 6, and 10 following screening

  8. Change in Treatment Satisfaction

    Treatment satisfaction will be measured through the completion of the Treatment Satisfaction Questionnaire For Medication (TSQM).

    Measured: Weeks 2, 6, and 10 following screening

  9. Change in Tolerability: Number of Attacks

    Change in Tolerability will be measured by the number of attacks.

    Measured: Weeks 2, 6, and 10 following screening

  10. Change in Tolerability: SF-12 Survey

    Change in Tolerability will be measured by the completion of the SF-12 survey.

    Measured: Weeks 2, 6, and 10 following screening

  11. Change in Tolerability: Vital Signs

    Change in Tolerability will be measured by vital signs.

    Measured: Weeks 2, 6, and 10 following screening

  12. Change in Tolerability: CBC

    Change in Tolerability will be measured by a complete blood count (CBC).

    Measured: Weeks 2, 6, and 10 following screening

  13. Change in Tolerability: CMP

    Change in Tolerability will be measured by a comprehensive metabolic panel (CMP).

    Measured: Weeks 2, 6, and 10 following screening

  14. Change in Tolerability: TSQM

    Change in Tolerability will be measured by the completion of the Treatment Satisfaction Questionnaire For Medication (TSQM).

    Measured: Weeks 2, 6, and 10 following screening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2017
  2. Study start14 Dec 2018
  3. Primary completion14 Dec 2018
  4. Study completion14 Dec 2018

Why it stopped: Resource and time constraints were encountered by product manufacturer and study team.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03374709
Sponsor's protocol ID
17-1398
Status last verified
Oct 2019
First submitted
9 Aug 2017
Last updated
1 Nov 2019
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 27306631

  • 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.

    PubMed 18721143

  • 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.

    PubMed 22588748

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

    PubMed 21280505

  • 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.

    PubMed 25361481

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oxtellar XR 150Mg Extended Release Tablet in people with Trigeminal Neuralgia, run by University of Colorado, Denver.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain associated with trigeminal neuralgia (BPI) (time frame: Weeks 2, 6, and 10 following screening). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03374709, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.

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