JNNP: The efficacy and safety of laconamide-assisted treatment of primary systemic strong-straight convulsive epilepsy: a double-blind, randomized, placebo-controlled trial.

Iddable systemic epilepsy (IGEs) accounts for 20%-55% of all seizures and is characterized by different seizure types (e.g., myoclonics, primary systemic strong straightness seizures (PGTCS).
PGTCS is associated with an increased risk of injury and sudden death in people with epilepsy.
treatment of PGTC is complex for IGA patients.
in the European Union, the United States and other countries, Lakosemi is approved for single treatment and complementary treatment for patients with (partial seizures) with eclampsia (over 4 years of age).
-blind, placebo-controlled trial (SP0982; NCT02408523) was conducted to evaluate the effectiveness and safety of PGTCS in lakosemi-assisted treatment of IKE patients (4 years of age).
the types of seizures associated with IGE may be uncommon and difficult to quantify, leading to lengthy trials and slow registration, it is difficult to study the efficacy of AED by assessing the decrease in the frequency of seizures.
: The program was a phase III, double-blind, randomized, placebo-controlled, multi-center trial of IGE patients taking one to three AEDs.
tests were conducted in North America, Latin America, Europe and the Asia-Pacific region.
written informed consent to all patients (or their legal representatives).
If the patient is 4 years of age or older and has been diagnosed with IGE with a classifiable PGTCS, and is diagnosed with IGE at least 24 weeks prior to the first visit, and becomes ill before the age of 30.
eligible patients were randomly divided into 1:1 groups, receiving lakocemi or placebo (twice a day) and classified by PGTCS frequency (≥2/28 days) and age of informed consent (from 4 to 12 years of age, from 12 to 18 years of age and 18 years of age).
the trial program randomly selected 250 patients.
trials included four weeks of prospective trials and a treatment period of 6 to 24 weeks (6 weeks of titration and up to 18 weeks of maintenance).
to ensure a minimum exposure for safety assessments, patients must complete at least 6 weeks of trial treatment.
in the course of the experiment, the dose increased in weekly terms from the starting dose of 2 mg/kg/day or 100 mg/day to the target maintenance dose range (8-12 mg/kg in pediatric patients with a weight of 30 kg) kg/day; paediatric patients weighing between 30 kg and 50 kg are 6-8 mg/kg/day; 300-400 mg/day, suitable for adults and pediatric patients weighing 50 kg.
duration of the treatment period continued until the end of the treatment period of 6 weeks, followed by 30 days of safe follow-up.
: The main outcome was during the 24-week (166-day) treatment period.
Other outcomes associated with seizures included a reduction of at least 50%-75% in PGTCS frequency every 28 days, a percentage of patients without PGTCS observed and a percentage of patients with no systemic seizures observed, and a 50%/75% decrease in the percentage of days of myoclonic seizures per 28 days compared to prospective results.
for IGI and PGTCS patients, Lacosamide is generally safe and well-to-do.
most common TAAE for laconamide is dizziness, drowsiness and headache, consistent with previously reported open-label pilot studies in patients with retinal epilepsy and IGE and unconstited PGTC patients.
group of pediatric patients was consistent with the overall population.
, however, the number of patients is small and the results should be interpreted with caution, as the trial is unable to assess the significantness of the sub-group.
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