Main Entry Criteria. Children and adolescents with new-onset epilepsy (5 to 18 years)

Comparator. Phenytoin (PHT)

Number of Patients. 193

Primary Outcome Variable. Efficacy, tolerability, and clinical utility (treatment retention)

Results. There were no differences in seizure freedom in patients receiving oxcarbazepine (300 to 1,350 mg/day) versus those receiving PHT (100 to 400 mg/day) (61% seizure free versus 60% seizure free, respectively). The number of premature discontinuations due to adverse effects was significantly lower in the oxcarbazepine group than in the PHT group (p = 0.002).

Main Entry Criteria. Children and adults with new-onset epilepsy (10 to 69 years)

Comparator. Placebo

Number of Patients. 67

Primary Outcome Variable. Time to first seizure

Results. Intention-to-treat analysis revealed significantly longer time to first seizure in the oxcarbazepine than in placebo group. Median seizure reduction was significantly
higher in oxcarbazepine group compared to placebo.

Main Entry Criteria. Adolescents and adults with new-onset focal or generalized seizures (15 to 65 years)

Comparator. Valproate (VPA); patients were treated with daily doses of oxcarbazepine or VPA between 900 and 2,400 mg/day.

Number of Patients. 249

Primary Outcome Variable. Seizure freedom and tolerability

Results. No statistically significant differences were found between the groups with respect to seizure freedom or discontinuation due to side effects.

Main Entry Criteria. Adolescents and adults with new-onset focal or generalized seizures (16 to 65 years)

Comparator. Oxcarbazepine 600 to 2,100 mg/day or PHT 100 to 650 mg/day

Number of Patients. 287

Primary Outcome Variable. Efficacy, tolerability, and clinical utility (treatment retention)

Results. In the efficacy analysis, no significant differences were found between the treatment groups. The number of premature discontinuations due to adverse effects showed a significant difference in favor of oxcarbazepine. There was no significant difference between the groups with respect to the total number of premature discontinuations due to adverse events.

Main Entry Criteria. Patients with new-onset focal or generalized seizures (15 to 65 years)

Comparator. Carbamazepine (CBZ) (300 to 1,400 mg/day), oxcarbazepine (300 to 1,800 mg/day)

Number of Patients. 235

Primary Outcome Variable. Efficacy (seizure frequency) and tolerability (side effects)

Results. There was no significant difference in the number of seizure-free patients in the oxcarbazepine versus CBZ treatment groups.
Oxcarbazepine caused significantly fewer “severe” side effects than CBZ did; global evaluation of tolerability demonstrated a trend toward better tolerability of oxcarbazepine.

Main Entry Criteria. Uncontrolled partial seizures in patients aged ≥12 years and weighing ≥41 kg (≥90 pounds)

Comparator. Oxcarbazepine 2,400 versus 300 mg/day

Number of Patients. 143

Primary Outcome Variable. Titrated on oxcarbazepine up to 2,400 mg/day (while CBZ was discontinued). Thereafter, patients entered the blinded phase, where either oxcarbazepine was continued at 2,400 mg/day or the dose of oxcarbazepine was down-titrated to 300 mg/day. The predefined exit criteria included a twofold increase in seizure frequency, a twofold increase in the highest consecutive 2-day seizure frequency, the occurrence of generalized tonic-clonic seizure if it was not present during the baseline evaluation phase, or prolonged generalized tonic-clonic seizures.

Results. Exit criteria were met more frequently by patients treated with oxcarbazepine monotherapy at a dosage of 300 mg/day than by patients treated with oxcarbazepine monotherapy at a dosage of 2,400 mg/day. Forty-seven patients did not progress to the blinded part of the trial because of side effects.

Main Entry Criteria. Patients with uncontrolled partial seizures, aged ≥12 years and weighing ≥41 kg (≥90 pounds)

Comparator. Oxcarbazepine 2,400 versus 300 mg/day

Number of Patients. 87

Primary Outcome Variable. Patients were titrated on oxcarbazepine 300 or 2,400 mg/day. Thereafter, patients entered the blinded phase, where other antiepileptic drugs (AEDs)
were discontinued. Patients continued oxcarbazepine at either 300 or 2,400 mg/day. The predefined exit criteria were the same as that in the preceding text.⁷,⁸

Results. The percentage of patients meeting the predefined exit criteria was significantly lower for the 2,400 mg/day group than the 300 mg/day group. In addition, there was a significant difference in time to exit in favor of the 2,400 mg/day group.

Main Entry Criteria. Adult patients undergoing epilepsy surgery evaluation in the epilepsy-monitoring unit

Comparator. Placebo, oxcarbazepine 1,200 mg b.i.d.

Number of Patients. 102

Primary Outcome Variable. Time to meeting one of the exit criteria (completion of the 10-day trial, four partial seizures, two new-onset generalized seizures, serial seizures, or status epilepticus)

Results. Significantly more number of the patients treated with oxcarbazepine completed the study in comparison with the patients treated with placebo. Logistic regression indicated that the odds of a placebo-treated patient meeting the seizure exit criterion were seven times higher than that for an oxcarbazepine-treated patient. Seventy-five percent of patients treated with oxcarbazepine reported side effects (mostly involving the nervous system, gastrointestinal system, and skin including pruritus and diplopia) versus 57% of patients who received placebo.