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Researchers are conducting the X-TOLE3 Phase 3 clinical trial to evaluate the safety, tolerability, and effectiveness of XEN1101 as an additional treatment for adults with focal-onset seizures. The study focuses on measuring changes in seizure frequency when XEN1101 is added to existing antiseizure medications compared to placebo. Participants must have a confirmed diagnosis of focal epilepsy and have tried at least two antiseizure medications without achieving seizure freedom. About 360 participants will be randomly assigned in equal groups to receive either XEN1101 at 25 mg, 15 mg, or a placebo. The study includes up to 9.5 weeks of baseline observation to record seizure frequency, followed by 12 weeks of double-blind treatment where participants take the assigned capsules once daily with an evening meal. Those who complete this period may join a separate open-label extension to continue XEN1101 treatment, while others will enter an 8-week follow-up after treatment ends. During the study, participants will maintain accurate seizure diaries and continue stable doses of 1 to 3 antiseizure medications. Researchers will monitor seizure frequency changes from baseline through the 12-week treatment. Safety and tolerability will also be assessed throughout the trial. The total participation includes baseline, treatment, and follow-up periods to ensure thorough evaluation of the treatment's impact.

Researchers are evaluating the safety and tolerability of TAK-861 in people with narcolepsy type 1 (NT1) who have already been exposed to TAK-861 in earlier studies. The study also aims to observe improvements in symptoms such as excessive daytime sleepiness and the frequency of cataplexy episodes. This long-term extension trial continues from previous phase 2 and phase 3 trials and includes participants who completed those earlier studies. All participants in this trial will receive TAK-861 tablets. Those who were previously given a placebo in parent trials will be randomly assigned to a dose of TAK-861. The study plans to enroll up to 500 participants worldwide and will last approximately 5 years, or until the study is stopped or the drug is approved and launched. Participants will visit clinics multiple times, with some visits possibly done at home, and will have a follow-up check 4 weeks after their last dose. During the study, participants will be monitored for treatment-emergent adverse events from the time they consent until 4 weeks after their final dose, covering up to about 5 years. Researchers will assess safety and tolerability regularly through these visits and follow-ups. The focus is on identifying any side effects and understanding the long-term effects of TAK-861 in people with NT1.

Researchers are evaluating the effectiveness and safety of BHV-7000 in adults with refractory focal onset epilepsy, a condition where seizures originate in one area of the brain and do not respond well to current treatments. This Phase 2/3 clinical trial aims to determine whether BHV-7000 can reduce seizure frequency in this population. The study is divided into two parts. In Part A, participants are randomly assigned to receive either 25 mg or 50 mg of BHV-7000, or a matching placebo, taken once daily. After completing Part A, participants move to Part B, where they are randomized to receive 75 mg of BHV-7000 or a matching placebo, also taken once daily. Both parts are randomized and double-blinded to ensure unbiased results. Participants will be monitored from Week 8 to Week 20 of each part for changes in average seizure frequency, serious adverse events, discontinuations due to side effects, and laboratory abnormalities. Researchers will track seizure diaries and assess safety and tolerability throughout the study. The total duration includes both study parts with regular evaluations to measure the drug’s impact and participant safety.

Researchers are investigating the safety, tolerability, and effectiveness of XEN1101 as an additional treatment for people with primary generalized tonic-clonic seizures (PGTCS) who have generalized epilepsy and are already taking 1 to 3 anti-seizure medications. This phase 3, multicenter, randomized, double-blind, placebo-controlled study includes participants aged 12 years and older and aims to better understand how XEN1101 affects seizure frequency compared to placebo. Participants will be randomly assigned to receive either XEN1101 or a placebo capsule once daily with their evening meal during a 12-week double-blind treatment period. Those aged 18 and older will take a 25 mg dose of XEN1101 or placebo, while those aged 12 to under 18 may receive 15 mg, 25 mg, or placebo. Before this period, participants will have up to 9.5 weeks to record their baseline seizure frequency. After completing the double-blind period, participants can join an open-label extension study for continued XEN1101 treatment or enter an 8-week follow-up phase if they do not enroll in the extension. During the study, participants will keep detailed seizure diaries and maintain stable doses of their anti-seizure medications. Researchers will monitor seizure frequency changes, safety, and tolerability throughout the treatment. The main measurement is the median percent change in monthly primary generalized tonic-clonic seizure frequency from baseline through the 12-week treatment. Safety follow-up and monitoring will continue during the post-treatment follow-up or open-label extension periods, with total participation lasting several months depending on extension enrollment.

Researchers are evaluating the impact of cenobamate, a treatment used alongside other therapies, on healthcare resource use in adults with epilepsy who have uncontrolled focal-onset seizures despite previous treatments. This retrospective observational study aims to compare healthcare utilization before and after starting cenobamate treatment. The study includes data from 200 patients gathered from 10 sites across 5 countries. The study collects medical chart data to analyze healthcare resource use related to epilepsy over a 12-month period following the start of cenobamate treatment. Participants must have had at least six months of medical records before and twelve months after beginning cenobamate, with data gaps no longer than six months. No new interventions are administered during the study as it relies on past medical records. Participants' data will be reviewed to assess healthcare resource use related to epilepsy, focusing on differences before and after cenobamate treatment. Researchers will monitor treatment impact over 12 months, considering early and later treatment lines. The study includes patients aged 18 and older who have had at least one seizure per month in the six months before starting cenobamate. Consent for data processing is required for inclusion.