A Phase 4 interventional study of Oxtellar XR 150Mg Extended Release Tablet in Trigeminal Neuralgia, sponsored by University of Colorado, Denver. Withdrawn. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by University of Colorado, Denver · Phase 4, Interventional, and Treatment
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To evaluate the affect Oxtellar XR (Extended Release) has on neurology patients with trigeminal neuralgia (TN), and if it impacts their quality of life.
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.
140 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.
Browse Trigeminal Neuralgia studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm includes subjects who have been prescribed Oxtellar XR 150Mg Extended Release Tablets.
Drug: Oxtellar XR 150Mg Extended Release Tablet
Oxtellar XR
Also known as: Oxtellar XR 300Mg Extended Release Tablet, Oxtellar XR 600Mg Extended Release Tablet
Change in pain associated with trigeminal neuralgia (BPI)
Pain associated with trigeminal neuralgia as measured by the Brief Pain Inventory (BPI) facial.
Time frame: 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).
Time frame: Weeks 2, 6, and 10 following screening
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
Time frame: Weeks 2, 6, and 10 following screening
Change in Safety: Number of Attacks
The subjects Safety profile will be measured based upon the number of attacks experienced.
Time frame: Weeks 2, 6, and 10 following screening
Change in Safety: SF-12 Survey
The subjects Safety profile will be measured based upon completion of the SF-12 survey
Time frame: Weeks 2, 6, and 10 following screening
Change in Safety: Heart Rate
The subjects Safety profile will be measured based upon any noted changes in heart rate.
Time frame: Weeks 2, 6, and 10 following screening
Change in Safety: Blood Pressure
The subjects Safety profile will be measured based upon any noted changes in Blood pressure.
Time frame: Weeks 2, 6, and 10 following screening
Change in Safety: CBC
The subjects Safety profile will be measured based upon a complete blood count (CBC).
Time frame: Weeks 2, 6, and 10 following screening
Change in Safety: CMP
The subjects Safety profile will be measured based upon a Comprehensive Metabolic Panel (CMP).
Time frame: Weeks 2, 6, and 10 following screening
Change in Treatment Satisfaction
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
Change in Tolerability: Number of Attacks
Change in Tolerability will be measured by the number of attacks.
Time frame: Weeks 2, 6, and 10 following screening
Change in Tolerability: SF-12 Survey
Change in Tolerability will be measured by the completion of the SF-12 survey.
Time frame: Weeks 2, 6, and 10 following screening
Change in Tolerability: Vital Signs
Change in Tolerability will be measured by vital signs.
Time frame: Weeks 2, 6, and 10 following screening
Change in Tolerability: CBC
Change in Tolerability will be measured by a complete blood count (CBC).
Time frame: Weeks 2, 6, and 10 following screening
Change in Tolerability: CMP
Change in Tolerability will be measured by a comprehensive metabolic panel (CMP).
Time frame: Weeks 2, 6, and 10 following screening
Change in Tolerability: TSQM
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
No study locations are listed for this record.
Ran from Dec 2018 to primary completion in Dec 2018, 0 months.
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This study is withdrawn, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oxcarbazepine
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