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Researchers are evaluating the clinical efficacy, safety, and tolerability of XEN1101 as an additional treatment for people with focal-onset seizures in a Phase 3 randomized, double-blind, placebo-controlled study. This trial aims to compare two doses of XEN1101 with a placebo to see how well the medication can reduce seizure frequency in patients who continue their current antiseizure medications. The study involves adults diagnosed with focal epilepsy who have tried at least two antiseizure medicines without achieving seizure freedom. About 360 participants will be randomly assigned to receive either 25 mg or 15 mg of XEN1101 or a placebo once daily with an evening meal. The study includes up to 9.5 weeks of baseline monitoring to track seizure frequency followed by 12 weeks of blinded treatment. Participants maintaining the study drug can then join an open-label extension to continue treatment or enter an 8-week follow-up after treatment ends. Throughout the study, participants will keep accurate seizure diaries and continue their stable antiseizure medications. Researchers will measure the median percentage change in seizure frequency from baseline through the 12-week treatment period, along with secondary outcomes like the proportion of participants with at least a 50% reduction in seizures and patient-reported improvement. Safety will be monitored from screening until 56 days after the last dose. Overall, participants are involved for the baseline, treatment, and follow-up phases lasting several months.

Researchers are evaluating the safety and tolerability of TAK-861 in people with narcolepsy type 1 NT1. This study focuses on participants who have already been exposed to TAK-861 doses in previous clinical trials. The goal is to monitor how TAK-861 affects symptoms such as excessive daytime sleepiness and cataplexy episodes over a long period. All participants in this trial will receive TAK-861 tablets. Those who previously received a placebo will be randomly assigned to one of the TAK-861 dose groups. The study is a long-term extension conducted worldwide and is expected to last approximately five years or until the product is approved or the study is stopped. Participants may switch doses as needed and will attend multiple clinic visits, some of which can be done at home. Throughout the trial, participants will be regularly assessed for safety by tracking any treatment-emergent adverse events. Researchers will also measure changes in sleep latency, sleepiness scores, and cataplexy rates compared to baseline data from earlier trials. Follow-up assessments will take place four weeks after the final dose to monitor ongoing effects and ensure participant safety.

Researchers are evaluating BHV-7000 as a treatment for adults with refractory focal onset epilepsy, a form of epilepsy that does not respond to standard anti-seizure medications. The study aims to determine if BHV-7000 can reduce seizure frequency and assess its safety and tolerability. This Phase 23 clinical trial is sponsored by Biohaven Therapeutics Ltd. and involves participants aged 18 to 75 years with a diagnosis of focal epilepsy lasting at least one year and resistant to previous treatments. The trial consists of two parts. In Part A, participants are randomly assigned to receive either 25 mg or 50 mg of BHV-7000 once daily or a matching placebo. After completing Part A, participants may enter Part B, which involves randomization to either 75 mg of BHV-7000 once daily or placebo. Both parts are blinded, meaning neither participants nor researchers know who receives the active drug or placebo during the treatment periods. Participants will keep accurate seizure diaries throughout the study to track seizure frequency. Researchers will monitor safety by recording adverse events and laboratory abnormalities from Week 8 to Week 20 in both parts. The main outcome measured in Part B is the change in average seizure frequency over 28 days compared to baseline. Secondary outcomes include the percentage of participants with significant seizure reduction and seizure freedom during the study. The total participation duration includes treatment and follow-up assessments over several weeks.

This research aims to evaluate the effects of ALKS 2680 tablets on adults with Narcolepsy Type 1 NT1. The study focuses on measuring reductions in daytime sleepiness, cataplexy sudden loss of muscle tone, and overall disease symptoms. Participants diagnosed with NT1 according to official guidelines are included to assess the impact of the treatment compared to placebo. Participants will be randomly assigned to one of three groups two different doses of ALKS 2680 or a placebo. Each participant will take oral tablets daily for 12 weeks. The study is designed as a phase 3, randomized, double-blind, placebo-controlled trial to thoroughly evaluate the drugs efficacy and safety during this period. During the study, participants will undergo assessments including the Maintenance of Wakefulness Test to measure sleep latency, along with various scales and inventories to evaluate sleepiness, cataplexy rates, cognitive complaints, fatigue, and narcolepsy severity. Safety will be monitored through reports of adverse events over approximately 14 weeks. The total participation time spans the 12-week treatment period and follow-up for safety monitoring.

Researchers are evaluating the effects of ALKS 2680 tablets on adults with Narcolepsy Type 2 NT2. This Phase 3 study aims to measure changes in daytime sleepiness and overall disease symptoms by comparing ALKS 2680 with placebo tablets. The trial focuses on assessing how the treatment impacts participants ability to stay awake and their symptom severity over time. Participants will be randomly assigned to one of four groups three different doses of ALKS 2680 tablets or placebo tablets. All tablets are taken daily by mouth for 12 weeks. The study uses a triple-blind design to fairly compare the effects of ALKS 2680 against placebo. The treatment period lasts for 12 weeks, during which participants take their assigned tablets regularly. During the study, participants undergo various assessments including the Maintenance of Wakefulness Test to measure sleep latency, the Epworth Sleepiness Scale, and other cognitive and fatigue-related questionnaires. Researchers monitor changes from baseline to Week 12 to evaluate treatment effects. Safety is also tracked through reports of any adverse events. Overall, participants are involved for about 12 weeks of treatment and follow-up assessments.

Researchers are studying the use of XEN1101 as an additional treatment for people aged 12 years and older who have primary generalized tonic-clonic seizures PGTCS associated with generalized epilepsy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the clinical effectiveness, safety, and tolerability of XEN1101 when added to existing anti-seizure medications. Participants are currently taking 1 to 3 anti-seizure medications and have had probable or possible PGTCS for at least one year. Participants will be randomly assigned to receive either XEN1101 or a placebo. Those aged 18 years and older will receive a 25 mg daily dose of XEN1101 or placebo. Participants aged 12 to under 18 years may receive 15 mg, 25 mg, or placebo daily. The study includes a baseline period lasting up to 9.5 weeks to track seizure frequency, followed by a 12-week double-blind treatment period where participants will take the assigned capsules once daily with an evening meal. After completing this period, participants can join an open-label extension study for continued XEN1101 treatment or enter an 8-week post-treatment follow-up if they do not enroll. During the study, participants will keep accurate seizure diaries and attend scheduled visits to monitor their health and response to treatment. Researchers will evaluate changes in monthly seizure frequency as the main outcome. Additional assessments will track safety, tolerability, and other measures throughout the treatment and follow-up periods. Overall participation may last several months, including baseline assessment, treatment, possible extension, and follow-up phases.

Researchers are evaluating how the drug cenobamate affects healthcare resource use for adults with epilepsy who have uncontrolled focal onset seizures. This observational, retrospective study compares medical resource use before and after patients start cenobamate as an additional therapy because previous anti-seizure medications were not effective or tolerable. Data from medical charts of 200 patients across 10 sites in 5 countries will be collected and analyzed. The study focuses on adult patients who began treatment with cenobamate as adjunctive therapy according to approved guidelines. Patients included have uncontrolled focal seizures despite 2 to 5 prior anti-seizure medications and have at least 6 months of data before starting cenobamate and 12 months of data afterward. This retrospective chart review gathers real-world data without altering patient treatment. Participants medical records will be reviewed for healthcare resource use related to epilepsy, including hospital visits, emergency care, medication use, surgeries, and phone or virtual contacts over a 12-month period before and after starting cenobamate. Researchers will also assess safety data and how concomitant anti-seizure medications change. The study is conducted under data protection regulations and will provide insights into the impact of cenobamate on managing uncontrolled focal seizures.