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

October 30, 2019 updated by: University of Colorado, Denver

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group
This arm includes subjects who have been prescribed Oxtellar XR 150Mg Extended Release Tablets.
Drug: Oxtellar XR 150Mg Extended Release Tablet
Oxtellar XR
Other Names:
  • Oxtellar XR 300Mg Extended Release Tablet
  • Oxtellar XR 600Mg Extended Release Tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in pain associated with trigeminal neuralgia (BPI)
Time Frame: Weeks 2, 6, and 10 following screening
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)
Time Frame: Weeks 2, 6, and 10 following screening
Pain associated with trigeminal neuralgia as measured by a Visiual Analog Scale (VAS).
Weeks 2, 6, and 10 following screening

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Quality of Life
Time Frame: Weeks 2, 6, and 10 following screening
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
Change in Safety: Number of Attacks
Time Frame: Weeks 2, 6, and 10 following screening
The subjects Safety profile will be measured based upon the number of attacks experienced.
Weeks 2, 6, and 10 following screening
Change in Safety: SF-12 Survey
Time Frame: Weeks 2, 6, and 10 following screening
The subjects Safety profile will be measured based upon completion of the SF-12 survey
Weeks 2, 6, and 10 following screening
Change in Safety: Heart Rate
Time Frame: Weeks 2, 6, and 10 following screening
The subjects Safety profile will be measured based upon any noted changes in heart rate.
Weeks 2, 6, and 10 following screening
Change in Safety: Blood Pressure
Time Frame: Weeks 2, 6, and 10 following screening
The subjects Safety profile will be measured based upon any noted changes in Blood pressure.
Weeks 2, 6, and 10 following screening
Change in Safety: CBC
Time Frame: Weeks 2, 6, and 10 following screening
The subjects Safety profile will be measured based upon a complete blood count (CBC).
Weeks 2, 6, and 10 following screening
Change in Safety: CMP
Time Frame: Weeks 2, 6, and 10 following screening
The subjects Safety profile will be measured based upon a Comprehensive Metabolic Panel (CMP).
Weeks 2, 6, and 10 following screening
Change in Treatment Satisfaction
Time Frame: Weeks 2, 6, and 10 following screening
Treatment satisfaction will be measured through the completion of the Treatment Satisfaction Questionnaire For Medication (TSQM).
Weeks 2, 6, and 10 following screening
Change in Tolerability: Number of Attacks
Time Frame: Weeks 2, 6, and 10 following screening
Change in Tolerability will be measured by the number of attacks.
Weeks 2, 6, and 10 following screening
Change in Tolerability: SF-12 Survey
Time Frame: Weeks 2, 6, and 10 following screening
Change in Tolerability will be measured by the completion of the SF-12 survey.
Weeks 2, 6, and 10 following screening
Change in Tolerability: Vital Signs
Time Frame: Weeks 2, 6, and 10 following screening
Change in Tolerability will be measured by vital signs.
Weeks 2, 6, and 10 following screening
Change in Tolerability: CBC
Time Frame: Weeks 2, 6, and 10 following screening
Change in Tolerability will be measured by a complete blood count (CBC).
Weeks 2, 6, and 10 following screening
Change in Tolerability: CMP
Time Frame: Weeks 2, 6, and 10 following screening
Change in Tolerability will be measured by a comprehensive metabolic panel (CMP).
Weeks 2, 6, and 10 following screening
Change in Tolerability: TSQM
Time Frame: Weeks 2, 6, and 10 following screening
Change in Tolerability will be measured by the completion of the Treatment Satisfaction Questionnaire For Medication (TSQM).
Weeks 2, 6, and 10 following screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jacquelyn Bainbridge, PharmD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 14, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-1398

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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