Status:
WITHDRAWN
Oxtellar Extended Release (Oxcarbazepine Extended Release) Patients With Trigeminal Neuralgia
Lead Sponsor:
University of Colorado, Denver
Conditions:
Trigeminal Neuralgia
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 eff...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03374709
Start Date
December 14 2018
End Date
December 14 2018
Last Update
November 1 2019
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