Overview

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

Status:
Withdrawn
Trial end date:
2018-12-14
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Colorado, Denver
Treatments:
Oxcarbazepine
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)