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Researchers are conducting a Phase 3 clinical trial to study the effects of relutrigine in people with developmental and epileptic encephalopathies (DEEs). The study is designed to evaluate the drug's efficacy, safety, tolerability, and how the body processes it compared to a placebo. This trial includes participants aged 2 to 65 years who have experienced seizure onset before age 12 and have a confirmed diagnosis of DEE. Participants will be randomly assigned to receive one of two doses of relutrigine (1.0 mg/kg/day or 1.5 mg/kg/day) or a placebo. The medication is given once daily either by mouth or through a gastrostomy or jejunostomy tube. After the initial double-blind treatment period, there is an open-label extension where all participants may receive the study drug. During the study, participants will be monitored for changes in seizure frequency over 16 weeks as the primary outcome. Safety and tolerability will also be assessed throughout the trial. Various evaluations, including heart monitoring and seizure tracking, will be conducted to ensure participant well-being. The overall study will track participants from screening through treatment and follow-up phases to gather comprehensive data about relutrigine's effects.

Researchers are evaluating the effectiveness and safety of Xeomin injections in preventing chronic migraine. This Phase 3 clinical trial compares Xeomin to placebo injections given into muscles of the head and neck. Participants have chronic migraine diagnosed for at least 12 months and meet specific headache and migraine day criteria. The study aims to measure changes in monthly migraine days over time with Xeomin treatment. Participants will receive four treatments spaced about 12 weeks apart over a total study duration of 52 to 55 weeks. The treatments involve injections of either Xeomin or placebo solution prepared with sodium chloride. Visits occur approximately every 4 weeks, totaling 14 visits: the first, last, and four treatment visits are on-site, while the other eight visits are remote via phone or video call. During the study, participants will keep headache diaries to track migraine and headache days. Researchers will focus on the change in monthly migraine days from baseline to six months after the first injection. Safety and effectiveness are monitored throughout, with frequent assessments during both on-site and remote visits to ensure accurate tracking of migraine symptoms and any side effects.

Researchers are evaluating the effect of Xeomin injections compared to placebo injections for preventing episodic migraine. This phase 3 clinical trial focuses on adults who experience episodic migraine, aiming to measure changes in the number of migraine days per month. Participants must have a diagnosis of episodic migraine for at least 12 months and meet specific headache frequency criteria. Participants will receive four treatments of either Xeomin or placebo injections into muscles of the head and neck, with treatments spaced about 12 weeks apart. The entire trial lasts approximately 52 to 55 weeks, beginning with a screening period of 4 to 5 weeks. There are about 14 visits in total, with the first, last, and four treatment visits conducted on-site, while the other visits are held remotely via phone or video. Throughout the study, participants will track their migraine days using a headache diary, and researchers will assess changes in monthly migraine frequency from baseline to six months after the first injection. Regular monitoring includes both in-person and remote assessments. The primary outcome focuses on the change in monthly migraine days between baseline and month six after treatment initiation.

Researchers are evaluating the safety, tolerability, and effectiveness of LP352 in reducing seizures among children and adults diagnosed with Dravet Syndrome (DS). This phase 3, double-blind, randomized, placebo-controlled study aims to compare LP352 with a placebo to better understand its impact on seizure frequency in this population. The study involves participants aged 2 to 65 years and addresses the challenges patients with DS face due to various seizure types and treatment responses. Participants will receive either LP352 or a matching placebo, administered orally or through a feeding tube (G-tube or PEG tube). The study includes several phases: an initial screening period, followed by a titration period to adjust doses, then a maintenance period where treatment continues, and finally a taper period to gradually reduce treatment before a follow-up phase. The entire study duration is approximately 24 months. During the study, participants will be monitored for changes in the frequency of countable motor seizures compared to their baseline seizure activity over up to 15 weeks. They will be required to complete diaries throughout the study to track seizures and treatment adherence. Safety and tolerability will also be assessed throughout all study phases. The researchers will collect data on seizure counts and monitor participants' health to evaluate LP352's effects comprehensively.

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.

This trial investigates whether eptinezumab can reduce the number of migraine days in children and teenagers aged 6 to 17 with episodic migraine. The study focuses on pediatric participants who have had migraine headaches for at least six months, aiming to evaluate the preventive treatment potential of this medication. This is a Phase 3 randomized, double-blind, placebo-controlled study designed to assess both the effectiveness and safety of eptinezumab given intravenously. Participants will receive either eptinezumab or a placebo, both administered as a solution through an infusion. The study includes a screening period where migraine and headache frequency are recorded using an electronic diary. The main measurement is the change from baseline in the average number of monthly migraine days over the first 12 weeks of treatment. During the study, participants and their caregivers will complete headache diaries to track migraine occurrences. Researchers will monitor migraine frequency and evaluate safety throughout the trial. The primary outcome is the difference in migraine days per month compared to the start of the study, assessed over the 12-week treatment period. This study helps understand how well eptinezumab may prevent episodic migraine in the pediatric population.

Migraine is a condition that often causes moderate to severe headaches on one side of the head, sometimes with throbbing pain, nausea, vomiting, and sensitivity to light and sound. This study evaluates the safety and effectiveness of atogepant, a medicine approved for preventing migraines in adults, to see how well it works compared to placebo in preventing chronic migraines in participants aged 12 to 17 years. The study is a phase 3, double-blind trial where neither the participants nor the doctors know who receives the medicine or placebo. Participants will be randomly assigned to receive either oral atogepant tablets or placebo tablets once daily for 12 weeks. Following the treatment period, there will be a 4-week follow-up phase. The study involves about 420 participants at approximately 70 sites worldwide. Throughout the study, participants will visit hospitals or clinics regularly to complete daily diaries, undergo medical assessments and blood tests, report any side effects, and complete questionnaires. Researchers will measure the number of participants experiencing adverse events and track changes in the average monthly number of migraine days from the start of the study through week 12.

Researchers are evaluating the safety and effectiveness of low-dose and high-dose atogepant in children and adolescents aged 6 to 17 who experience episodic migraine. Migraines are moderate to severe headaches often accompanied by symptoms such as throbbing pain, nausea, and sensitivity to light and sound. While several treatments exist for adults, options for younger patients are limited, making this Phase 3 study important to understand how atogepant works in this younger population. Participants aged 6 to 17 will be randomly assigned to one of six groups to receive either placebo, low-dose atogepant, or high-dose atogepant tablets taken once daily by mouth for 12 weeks. The exact doses for children aged 6 to 11 will be decided after a pharmacokinetic substudy. After 12 weeks, participants may either have a follow-up visit 4 weeks after stopping the treatment or join an extension study to continue taking atogepant for an additional 52 weeks. During the study, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and to monitor for any side effects. They will also complete questionnaires to evaluate how treatment affects their migraines. The main outcomes measured are changes in the number of monthly migraine days over 12 weeks and the number of participants experiencing adverse events during the first 16 weeks. About 450 participants will be enrolled across roughly 100 sites worldwide.

Researchers are evaluating LP352, a treatment for seizures in children and adults with Developmental and Epileptic Encephalopathies (DEE), including Lennox-Gastaut Syndrome (LGS) and other DEE types. This Phase 3, double-blind, randomized, placebo-controlled study aims to assess the effectiveness, safety, and tolerability of LP352. The study involves participants aged 2 to 65 years who experience multiple types of motor seizures and have a history of developmental plateauing or regression. Participants will receive either LP352 or a matching placebo, administered orally or through a gastrostomy tube if needed. The study includes several phases: Screening, a Titration period to adjust dosing, a Maintenance period to continue treatment, followed by a Taper period to gradually reduce the medication, and a final Follow-Up phase. The entire study will last about 24 months. Throughout the study, participants will be closely monitored for changes in the frequency of their countable motor seizures compared to baseline over up to 15 weeks. Researchers will collect data through seizure diaries maintained by participants or caregivers, clinical assessments, and safety evaluations. The study also tracks adherence to treatment and overall tolerability to better understand the impact of LP352 on seizure control and patient well-being.

Researchers are evaluating the effectiveness and safety of a single inhaled dose of Staccato alprazolam compared to a placebo in quickly stopping prolonged seizure episodes in people aged 12 years and older with stereotypical prolonged seizures. This Phase 3 study aims to determine if the treatment can stop seizures within 90 seconds and prevent seizure recurrence for up to 2 hours after administration. Participants will receive one inhaled dose of either Staccato alprazolam or a placebo during the treatment period. The study is randomized, double-blind, and placebo-controlled, conducted at multiple outpatient centers. The intervention consists of a single administration designed to rapidly terminate seizure episodes. During the study, participants are closely monitored for seizure treatment success within 90 seconds and no seizure recurrence up to 2 hours post-treatment. Researchers will assess seizure control and safety outcomes throughout the treatment period. The study involves baseline assessments, caregiver involvement to observe seizures, and a focus on quick treatment response and safety over several hours following drug administration.