Monotherapy in adult patients
VIMPAT ESTABLISHED EFFICACY IN MONOTHERAPY.2
VIMPAT MET THE PRE-SPECIFIED CRITERIA FOR EFFICACY IN ADULTS WITH PARTIAL-ONSET SEIZURES.2
historical control's 95% prediction interval lower limit established the
efficacy of VIMPAT as monotherapy2,7
Trial demonstrated the efficacy of VIMPAT for conversion to monotherapy in adult patients with partial-onset seizures, with statistical superiority to the historical control.2
For the VIMPAT 400 mg/day (200 mg twice-daily) group, the estimate of the percentage of patients meeting at least 1 exit criterion was 30% (95% confidence interval: 25%, 36%). The upper limit of the 2-sided 95% confidence interval (36%) was below 65%, the lower limit of the historical control 95% prediction interval derived from the historical control data, meeting the pre-specified criteria for efficacy.2
The VIMPAT 300 mg/day (150 mg twice-daily) group also met the pre-specified criteria for efficacy.2
SELECT IMPORTANT SAFETY INFORMATION
Monotherapy: In the adult clinical trial, adverse reactions were generally similar to those observed and attributed to drug in adjunctive placebo-controlled trials, with the exception of insomnia (occurred at a higher rate of ≥2%).
VIMPAT USE AS MONOTHERAPY IN ADULTS WITH PARTIAL-ONSET SEIZURES WAS EVALUATED WITH A HISTORICAL CONTROL.2
THE VIMPAT HISTORICAL CONTROL STUDY WAS DESIGNED TO EVALUATE EFFICACY WITHOUT
THE EXPOSURE OF SUBJECTS TO SUBOPTIMAL AED DOSING.2,8
VIMPAT was tested in a conversion-to-monotherapy trial using a historical control group derived from a meta-analysis of data from 8 previous AED monotherapy trials of similar design, which utilized a subtherapeutic dose of an AED as a control.2,8
Trial design: Using a historical control to evaluate efficacy and safety in monotherapy2
- A historical control, multicenter, randomized trial* was conducted to assess the efficacy and safety of conversion to monotherapy with VIMPAT in epilepsy patients with partial-onset seizures (POS) on a stable regimen of 1 or 2 AEDs. Patients taking 2 AEDs must have been taking ≤50% of the minimum FDA-recommended maintenance dose of 1 of the 2 AEDs
- The primary efficacy variable was the percentage of patients taking VIMPAT 400 mg/day meeting 1 or more predefined exit criteria† of clinically relevant worsening of seizures8 by Day 112 of the maintenance phase compared to the percentage of patients exiting in the historical control group
- A lower exit percentage indicates superior outcome to historical control
Baseline demographics and characteristics (N=425)
- The study population profile appeared comparable to the historical control population.2 Patients averaged 17.2 years since diagnosis of epilepsy, with a median baseline seizure frequency of 6.6 per 28 days7
- History of, or presently having: baseline simple partial seizures, 47.3% (n=201); complex partial seizures, 85.4% (n=363); partial seizures with secondary generalization, 67.5% (n=287)‡
- 73.4% taking 1 background AED; 26.6% taking 2 background AEDs. Most common primary background AEDs: carbamazepine, lamotrigine, and levetiracetam§
*Patients were randomized 3 to 1 to receive either VIMPAT 400 mg/day or 300 mg/day.
†The exit criteria were 1 or more of the following: (1) doubling of average monthly seizure frequency during any 28 consecutive days, (2) doubling of highest consecutive 2-day seizure frequency, (3) occurrence of a single generalized tonic-clonic seizure, (4) clinically significant prolongation or worsening of overall seizure duration, frequency, type, or pattern considered by the investigator to require trial discontinuation, (5) status epilepticus or new onset serial/cluster seizures.
‡Some patients experienced more than 1 seizure type at baseline and, therefore, were represented in more than 1 group.
§Levetiracetam is a product manufactured by UCB.
Download Complimentary adult Monotherapy Pivotal Trial Publication
Wechsler RT, Li G, French J, et al. Conversion to lacosamide monotherapy in the treatment of focal epilepsy: Results from a historical-controlled, multicenter, double-blind study. Epilepsia. 2014;55(7):1088-1098.