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Partial Epilepsy clinical trials

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NCT ID: NCT05067634 Recruiting - Partial Epilepsy Clinical Trials

Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures

Start date: January 14, 2022
Phase: Phase 3
Study type: Interventional

Primary objective: To evaluate the safety and tolerability of cenobamate in pediatric subjects 2-17 years of age with partial-onset (focal) seizures

NCT ID: NCT04903314 Recruiting - Partial Epilepsy Clinical Trials

Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures

Start date: May 27, 2021
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to assess the pharmacokinetics of cenobamate (YKP3089) in pediatric subjects with partial-onset (focal) seizures following single and multiple-dosing.

NCT ID: NCT04513860 Approved for marketing - Partial Epilepsy Clinical Trials

Cenobamate Expanded Access Program (EAP)

Start date: n/a
Phase:
Study type: Expanded Access

This Cenobamate Expanded Access Program (EAP) is designed to continue providing treatment with Cenobamate (YKP3089) to patients with partial-onset epilepsy that were enrolled in the SK Life Science clinical trial YKP3089C013, YKP3089C017 or YKP3089C021.

NCT ID: NCT03478852 Recruiting - Epilepsy Clinical Trials

Investigating Epilepsy: Screening and Evaluation

Start date: March 28, 2018
Phase:
Study type: Observational

Background: Epilepsy affects about 1 percent of the U.S. population. Most people with epilepsy respond well to medicine, but some do not. Researchers want people who have diagnosed or suspected epilepsy to participate in ongoing studies. They want to learn more about clinical care for epilepsy. They want fellows and residents to learn more about the care of people with epilepsy. Objectives: To learn more about seizures and find ways to best treat people with drug-resistant epilepsy. Eligibility: Adults and children ages 8 years and older with diagnosed or suspected epilepsy Design: Participants will be screened with: Physical exam Medical history Questionnaires Participants will have many visits. They may be admitted to the hospital for several weeks. Their medication might be stopped or changed. Participants will have many tests: Blood and urine tests EEG: Wires attached to the head with paste record brain waves. This may be videotaped. Thinking and memory tests MRI: Participants lie on a table that slides in and out of a tube. They perform simple tasks in the tube. MEG: Participants lie on a table and place their head in a helmet to record brain waves. PET scan: Participants lie on a table that slides into a machine. A small amount of radioactive dye is injected into their arm with an IV. For the IV, a small tube is inserted into the arm with a needle. Participants will stay enrolled in this study if they join other epilepsy-related studies. They may be contacted at intervals for follow-up. Their participation will end if they have not been seen clinically for their epilepsy for 3 years.

NCT ID: NCT02535091 Completed - Partial Epilepsy Clinical Trials

Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

Start date: August 3, 2016
Phase: Phase 3
Study type: Interventional

This is a multicenter, open label study to assess the safety and pharmacokinetics of YKP3089 as adjunctive therapy in subjects with partial onset seizures. Initially, subjects taking phenytoin or phenobarbital will be enrolled followed by additional subjects taking anti-epileptic drugs (AED) other than phenytoin and phenobarbital to further investigate long-term safety.

NCT ID: NCT02076698 Completed - Surgery Clinical Trials

Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy

FRANCE
Start date: June 16, 2014
Phase: Phase 3
Study type: Interventional

The main objective of the study is twofold: 1. Assess the clinical efficacy of DBS on epilepsy according to their number and severity at 1 year follow up. 2. Perform a cost-effectiveness analysis from the perspective of Medicare at 1 and 2 years. The study hypothesis is that thalamic DBS (neurostimulation of the anterior nucleus of the thalamus) will decrease significantly, the frequency (potentially 50% reduction in severe crises) of the most severe seizures, in at least 50% of patients who have drug-resistant partial epilepsy; and should also improve significantly the quality of life through a gain of independence in activities of daily life, the possible recovery of functional abilities, recovery of social or professional activities.

NCT ID: NCT01866111 Completed - Partial Epilepsy Clinical Trials

A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

Start date: July 31, 2013
Phase: Phase 2
Study type: Interventional

This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with an 8-week prospective baseline and an 18 week double-blind treatment period (including a 6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study drug taper period (for subjects leaving the study) or a 2-week blinded conversion period (for subjects who will participate in the open-label extension). The primary objective of this study is to determine the effective dose range of YKP3089 as adjunctive therapy for the treatment of partial seizures. The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy population.

NCT ID: NCT01735032 Recruiting - Partial Epilepsy Clinical Trials

Multimodal Imaging in Pre-surgical Evaluation of Epilepsy

EPIMAGE
Start date: October 2012
Phase: N/A
Study type: Observational

Epilepsy is the most common chronic neurological disorder in the world, affecting more than 50 million people worldwide. Approximately 35% of patients with epilepsy are refractory to all available antiepileptic drugs. Drug-resistant epilepsies are often partial or focal. Patients with drug-resistant focal epilepsy suffer from an increased risk of death, primarily due to seizure-related fatalities, in comparison with the general population. The only therapeutic option for this form of epilepsy is the surgical removal of the region of the brain responsible for seizures, called the epileptogenic zone (EZ). This requires the precise localization of the EZ based on a comprehensive pre-surgical evaluation of patients. Today the gold standard for localizing the EZ and validating a non-invasive technique for localization of the EZ remains intracerebral stereo-EEG (stereo-electroencephalography or SEEG) recordings of spontaneous seizures. The implementation strategy of the intracerebral depth electrodes is guided by clinical and neuroimaging data, including anatomical Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) with FDG (fluoro-Deoxy-Glucose) and MagnetoEncephaloGraphy (MEG). Although the contribution of each technique in the pre-surgical localization of the EZ has already been shown, no wide-scale study has examined the cumulative contribution of these three techniques.

NCT ID: NCT01527513 Completed - Partial Epilepsy Clinical Trials

Effects of Eslicarbazepine Acetate (Esl, Bia 2-093) on Cognitive Function in Children With Partial Onset Seizures

Start date: August 2010
Phase: Phase 2
Study type: Interventional

To evaluate the effects of eslicarbazepine acetate on cognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures.

NCT ID: NCT01496612 Terminated - Depression Clinical Trials

Buspirone Therapy for Localized Epilepsy

Start date: November 22, 2011
Phase: Phase 2
Study type: Interventional

Background: Buspirone is a drug that is approved for the treatment of anxiety in adults. Studies suggest that buspirone might act on parts of the brain that can increase certain levels of brain activity. Increasing this brain activity may help decrease epileptic seizures that come from certain parts of the brain. Researchers want to see if buspirone can reduce seizure frequency in people with seizures who are already taking antiseizure medication. Objectives: To test whether buspirone can reduce the frequency of seizures in people whose seizures seem to start from one part of the brain. Eligibility: Individuals between 18 and 65 years of age who have seizures coming from one or more places in the brain. Participants must have tried at least two different antiseizure medications. Participants must also have had at least three seizures during a 1-month observation period while on current medicines. Design: Participants will have a screening visit with a physical exam and medical history. Participants will complete mood and memory testing scales. Blood, urine, and saliva samples will be collected. Participants will have a magnetic resonance imaging scan to evaluate brain structures that relate to epilepsy. They will also have a positron emission tomography scan to look at parts of the brain that are affected by buspirone. Participants will start taking a study drug (either buspirone or placebo) twice daily. They will keep a calendar of seizures and record any side effects. Treatment will be monitored with clinic visits and blood samples. After 12 weeks on the study drug, participants will gradually stop taking either the placebo or buspirone over two weeks. They will stay off the drug for another 2 weeks. After 2 weeks, participants will start taking a study drug that is the opposite of the one they had before. They will keep a calendar of seizures and record any side effects. Treatment will be monitored with clinic visits and blood samples. After 12 weeks on the study drug, participants will gradually stop taking either the placebo or buspirone. Participants will have a final followup visit with additional blood tests, mood and memory testing scales and imaging studies.