Long-term Cardiac Monitoring in Epilepsy
Focal EpilepsyIntractable Epilepsy4 moreThe purpose of this research study to investigate, classify, and quantify chronic cardiac rhythm disorders in three groups of patients with epilepsy (intractable focal epilepsy, controlled focal epilepsy and symptomatic generalized epilepsy). Patients with epilepsy have a higher risk for cardiac complications than the general population. With this study, we aim to understand more about these potential complications in patients with epilepsy and assess if treatments for cardiac problems should be evaluated more carefully in patients with epilepsy.
Effects of Diazepam on RNS Detections
EpilepsiesPartialTo assess the magnitude and duration of reduction in RNS recorded Detections and Long Episodes following intranasal administration of Valtoco®. All participants will have been implanted and treated with an RNS system for clinical purposes and regularly upload Detection and Long Episode data on a regular basis as part of regular clinical treatment. Participants will come to the clinic and be administered a single dose of Valtoco® via nasal spray. RNS recorded Detections and Long Episodes before and after Valtoco® administration will be compared. This is a pilot study, so all outcomes are exploratory.
Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
EpilepsyFocal Seizures1 moreThe primary efficacy objective of the study is to determine if adjunctive therapy of natalizumab 300 mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult participants with drug-resistant focal epilepsy. The secondary efficacy objective is to assess the effects of natalizumab versus placebo in drug-resistant focal epilepsy on additional measures of seizure frequency.
The Effects on Cognitive Function of Levetiracetam (Keppra®) Compared to Carbamazepine (Tegretol®,...
Focal EpilepsyUnlike the first generation antiepileptic medications, newer drugs for epilepsy such as levetiracetam are reported to have less adverse effect in children but not many studies have systematically reviewed the subject. This study aims to prospectively evaluate the effect of levetiracetam on neurocognition, behavioral issues and quality of life, as well as its seizure control efficacy and other adverse events in pediatric epilepsy patients, in comparison to carbamazepine, one of the classic antiepileptic medication, widely prescribed for both partial and generalized seizures, despite its well known side effects. This multicenter, open-label, parallel-group trial is expected to enroll 130 patients from age 4 to 16 woh will be randomized into two groups, which will be prescribed with levetiracetam or carbamazepine. Series of neuropsychological assessment and behavioral and life evaluations of the patients will be performed at baseline period and after the 52 weeks of study period.
Efficacy and Safety of Rapid Titration Protocols of Lacosamide
Focal EpilepsyThree different dose titration schedules are tested to find a way to reduce the titration period of lacosamide
Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With...
EpilepsyTo evaluate the long term effectiveness of Levetiracetam (LEV) monotherapy on Treatment Failure Rate in subjects with newly diagnosed partial onset seizures with or without secondary generalized seizures, compared to Oxcarbazepine (OXC) monotherapy over 50 weeks from the first dose
Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset...
Partial EpilepsiesTo evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients with partial onset epilepsy. Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility
Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal...
Partial EpilepsySleepiness and fatigue are the most common complaints of people with epilepsy and can have a negative impact on quality of life. Though unproven, these problems are often blamed on anti-seizure medications. The purpose of this study is to investigate the impact of the anti-seizure medication Lacosamide (Vimpat®) on sleep and wakefulness in adults with focal (partial onset) seizures. Focal epilepsy, also called partial epilepsy, is a disorder characterized by seizures arising from a localized network of neurons in the brain. Focal seizures usually begin a sensation or involuntary movement of a part of the body, an unusual feeling, or a disturbance in hearing, smell, vision, or consciousness. The study is open to adults 18 and older with focal seizures. Participation involves a physical exam, sleep testing at the Sleep Center, blood tests, completion of study questionnaires/diaries, and a random assignment to either take the study drug or placebo (often called a "look alike" or "sugar pill") for 5 to 8 weeks. There are 5 study visits. Participants will receive compensation for time spent in the study. If you would like more information on this study please contact the Cleveland Clinic Sleep Center: Dr. Nancy Foldvary-Schaefer: 216-445-2990 Monica Bruton: 216-444-6718
Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy...
EpilepsyPartialPatients with partial-onset seizures seen in community-based practices were to be included in this therapeutic use study to assess the safety and tolerability of Keppra (Levetiracetam) and to confirm the favorable safety of the drug found during clinical development to obtain further information about optimal dosing in daily clinical practice. Compared to previous registration trials, the study population corresponded more closely to that seen in daily clinical practice.
Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial...
EpilepsiesPartialThe purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of pregabalin in pediatric patients with partial onset seizures that are incompletely controlled on their current medications.