Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who...
SeizuresEpilepsies6 moreTo evaluate the efficacy and safety of diazepam in the management of refractory epilepsy in selected patients who require intermittent medical intervention for the control of episodes of acute repetitive seizures. In addition, to assess the support provided by caregivers who are not themselves or not under the direct supervision of health care professionals at the time of administration.
Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients...
EpilepsyEpilepsy1 moreThis study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of partial seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.
Evaluation of Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.
Seizure DisorderPartialTo determine long-term safety and efficacy of pregabalin in patients with partial seizures.
A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Difficult to...
EpilepsyEpilepsies2 moreThe purpose of the study is to evaluate the effectiveness and safety of topiramate as add-on therapy in patients with difficult to control partial onset seizures who are taking one or two standard anti-epileptic drugs.
A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset...
EpilepsyPartialTo evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an evaluation). Other neuropsychological clinical assessments will be performed during the 34 day length of the study.
An Open-Label Extension Study to Evaluate the Safety and Effectiveness of RWJ 333369 in Patients...
EpilepsyEpilepsies1 moreThe purpose of this study is to evaluate the safety and preliminary effectiveness of the novel compound RWJ-333369 in patients with partial onset seizures who are currently being treated with 1 or 2 concomitant antiepileptic drugs.
Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile...
Infantile SpasmsThe sponsor is developing a new paediatric formulation of vigabatrin to better adjust the dose to body weight and to limit waste of unused drug. The currently marketed vigabatrin (Sabril™) form only exists as 500 mg film coated tablets (for adults and children above 6 years) and 500 mg granules for oral solution sachets (for infants and children below 6 years). Sabril™ is not adapted for administration to infants when a fraction of the sachet is needed. Manual splitting of the sachet or lengthy and error-prone dilutions are often required. This study is a descriptive, non-randomized, open label multi-centric acceptability study in infants and children affected with infantile spasms. The primary objective is to describe the adherence to the new formulation. Secondary objectives include: evaluation of the palatability and user-friendliness of the new treatment, evaluation of the pharmacokinetic parameters of the new formulation, PK parameters, evaluation of the tolerance, measurement of taurine plasma levels. This study will recruit up to 40 patients with infantile spasms and pharmacoresistant partial epilepsy aged 1 month to 6 years in 23 clinical sites in France.
Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset...
Partial EpilepsyThis 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 other than phenytoin and phenobarbital to further investigate long-term safety.
Effects of Transcranial Direct Current Stimulation (TDCS) in Drug-resistant Partial Epilepsy
EpilepsyDrug-resistant partial epilepsy has a heavy impact on quality of life and sometimes on life expectancy itself. Only a minority of patients may benefit from a curative epilepsy surgery. Neurostimulation, which can be an effective add-on treatment, is currently mainly represented by vagus nervus stimulation. Transcranial direct current stimulation, a non -invasive technique already used in other areas of neurology, may be efficient on some partial epilepsies, in particular through the individual configuration of stimulation, made possible by recent technological advances. Main goal : To study the effect of transcranial electrical stimulation on the frequency of seizures in patients with drug-resistant partial epilepsy. Hypothesis : Reduction of 50% or more in the frequency of occurrence of seizures within 24 hours following an individually configured TDCS session: responders in real TDCS vs placebo stimulation.
A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in...
Partial EpilepsyThis 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.