The VALOR study is currently underway to determine if lacosamide (Vimpat®) can reduce the frequency of seizures in patients with idiopathic generalized epilepsy (IGE) who are already taking anti-epileptic medications. This international, multi-center trial is enrolling participants across 23 countries, including the United States.
Study Design and Patient Population
The VALOR study includes children and adults aged 4 years and older who have been diagnosed with IGE and experience primary generalized tonic-clonic (PGTC) seizures. To be eligible, participants must have experienced at least 3 PGTC seizures during the 16-week combined baseline period (12-week historical baseline plus 4-week prospective baseline) and be on a stable dose of one to two non-benzodiazepine anti-epileptic drugs (AEDs) or one to three AEDs (with one benzodiazepine) for at least 28 days prior to the first visit.
Patients are randomized to receive either lacosamide or a placebo, in addition to their current anti-epileptic medication. Participants have a 50% chance of receiving placebo. Following the controlled phase of the study, participants have the option to enroll in a two-year open-label extension study where all patients receive lacosamide.
Inclusion and Exclusion Criteria
Key inclusion criteria include a confirmed IGE diagnosis at least 24 weeks prior to the initial visit, disease onset before age 30, and EEG reports consistent with IGE, confirmed by a central reviewer. Exclusion criteria include a history of partial-onset seizures, symptomatic generalized epilepsy (e.g., Lennox-Gastaut Syndrome), a history of suicide attempts, and the use of certain medications such as clozapine or MAO-A inhibitors.
Lacosamide as Add-on Therapy
Lacosamide is an anti-epileptic drug approved for the treatment of partial-onset seizures. The VALOR study is investigating its potential as an add-on therapy for patients with IGE experiencing PGTC seizures. The primary endpoint is to assess the safety and efficacy of lacosamide versus placebo in this patient population. This study could provide valuable insights into the role of lacosamide in managing IGE and potentially offer a new treatment option for patients who continue to experience seizures despite being on existing anti-epileptic medications.
