Lacosaamine therapy assists in the treatment of primary systemic stoic-tymponic epilepsy in efficacy and safety: a double-blind, randomized, placebo-controlled trial.

Iddable systemic epilepsy (IGE) accounts for 20%-55% of all epilepsy and is characterized by different types of systemic seizures.
The treatment of myoclonic seizures and primary systemic strong-straight seizures (PGTCS) in patients with
IGE is complex, as certain anti-epileptic drugs (AEDs) may aggravate the associated type of seizure, such as arrhythmic or myoclonic seizures.
the European Union, the United States and other countries have approved the use of lacausamine for single-drug treatment and complementary treatment for seizures .4 years of age.
type of seizure associated with IGE may be uncommon and difficult to quantify, leading to long-term trials and slow grouping, making it difficult to study the efficacy of AED by assessing the decrease in seizure frequency.
: This is a phase III, double-blind, randomized, placebo-controlled, multi-center trial.
if the patient is 4 years of age and has a disease outbreak before the age of 30.
patients must maintain a stable dose of 1-2 non-benzodiazepines anti-epileptic drugs or 1-3 benzodiazepines anti-epileptic drugs must be used for epilepsy.
eligible patients were randomly treated with lacoamide or placebo (twice a day) on a 1:1 scale.
to ensure the minimum exposure required for safety assessments, patients are required to complete at least 6 weeks of trial treatment.
results: 242 patients were randomly assigned and received a 1x dose of the experimental drug (lactamide/placebo: n s 121 / n s 121).
patients (average age: 27.7 years; 58.7 per cent female) had a history of systemic seizures (99.6 per cent for strong-straight thronics and 38.8 per cent for myoclonics).
143/65 days of treatment with lacoamide/placebo.
risk of developing a second PGTCS during 24 weeks of treatment was significantly lower in the placebo group (p .lt;0.001; n s 118 / n s 121).
for lacoamide, it was not expected to estimate the time between the second PGTCS (50% of patients did not experience the second PGTCS) and the placebo was 77.0 days.
Kaplan-Meier estimates that at the end of the 24-week treatment period (day 166), lacoamide/placebo was exempt from PGTCS by 31.3% / 17.2% (difference 14.1%; p s 0.011).
compared to placebos, patients treated with lacosaamine were not observed to be affected by PGTCS (27.5% / 13.2%) during treatment (n s 119 / n s 121).
96/121 (79.3%) of patients treated with lacoamide had an emergency adverse event (placebo 79/121 (65.3%)), the most common being dizziness (23.1%), drowsiness (16.5%), and headache (14.0%).
no patients died during the trial.
for patients with uncontrolled PGTCS in IGEs, lacosamine is an effective and safe complementary treatment for anti-epileptic drugs.
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