Elaine C. Wirrell, M.D.

The purpose of this study is to assess the long-term safety and tolerability of GNX as adjunctive therapy for seizures associated with Tuberous Sclerosis Complex (TSC) in children and adults.

The purpose of this study is to evaluate the effectiveness of carisbamate (YKP509) as adjunctive treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with placebo in pediatric and adult subjects diagnosed with Lennox Gastaut Syndrome (LGS).

This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The blinded phase only will be described in this record. Participants will receive 1 of 2 doses of GWP42003-P or matching placebo. The primary clinical hypothesis is that there will be a difference between GWP42003-P and placebo in their effect on seizure frequency.

A clinical study to evaluate the effectiveness, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in children and young adults with genetically confirmed CDKL5 gene mutation.

The primary purpose of this study is to evaluate the safety, tolerability and efficacy of a single dose of ZX008 (Fenfluramine Hydrochloride) when added to standard of care and when added to Adjunctive Antiepleptic therapy to Stiripentol treatment in children and young adults with Dravet Syndrome

This is a multicenter, double-blind, parallel-group, placebo-controlled, study to assess the efficacy, safety, and PK of ZX008 when used as adjunctive therapy for uncontrolled seizures in pediatric and young adult subjects with Dravet syndrome. After an initial Screening and Baseline charting of seizure frequency, subjects who qualify for the study will be randomized (1:1:1) to receive either ZX008 (0.2 mg/kg/day, 0.8 mg/kg/day; maximum dose: 30 mg/day) or placebo. Randomization will be stratified by age group (< 6 years, ≥6 to 18 years). All subjects will be titrated to their randomized dose over a 14-day Titration Period. Following titration, subjects will continue treatment at their randomly assigned dose over a 12-week Maintenance Period. Subjects exiting the study will undergo a 2-week taper, unless they enroll in a follow-on study. Subjects will be followed for post-study safety monitoring. Parents/caregivers will use a diary daily to record the number/type of seizures, dosing, and use of rescue medication.

The primary purpose of this study is to investigate the long-term safety and tolerability of TAK-935/OV935 as an adjunctive therapy in patients with epileptic seizures.

The purpose of this trial is to assess the safety and effectiveness of Ganaxolone (GNX) compared to placebo as adjunctive therapy for seizures associated with Tuberous Sclerosis Complex (TSC) in children and adults as assessed by the change from baselinea in the frequency of countable major motor and focal seizures (primary endpoint seizuresb) during the double-blind phase.

The primary purpose of this study is to evaluate the effectiveness and safety of ZX008 in subjects with CDD.

The purpose of this study is to evaluate the effectiveness and safety of AMZ002, compared to vigabatrin, in the treatment of infantle spasms (IS).
 

The purpose of this study is to investigate the safety and potential antiepileptic effects of cannabidiol in children and young adults with Dravet syndrome

The purpose if this study is to investigate the safety and anti-seizure effectiveness of cannabidiol (GWP42003-P) in children and adults with Lennox-Gastaut syndrome.

The purpose of this study is to evaluate the course of neurodevelopmental status, adaptive status, quality of life, seizure frequency, and sleep in patients with Dravet syndrome (DS) over the timespan of two years.

To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet or Lennox-Gastaut syndromes.

The purpose of this study is to gather additional information on the long-term safety, tolerability, and impact on seizure frequency and duration of repeated doses of STK-001 administered every 4 months by intrathecal (IT) injection.

This is an international, multicenter, open-label, long-term safety study of ZX008 in pediatric and young adult subjects with Dravet syndrome who have successfully completed 14 weeks of treatment in the core study (ZX008-1501 and ZX008-1502).

The purpose of this study is to evaluate the long-term safety of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy.

The purpose of this study is to evaluate the safety and tolerability of single-ascending doses of STK-001 in patients with Dravet Syndrome.

The purpose of this study is to (1) determine how often children with epilepsy have delays in obtaining prescribed anti-seizure medications due to cost and prior authorization process (2) determine whether delays in obtaining medications, if present, affect seizure control and  (3) determine whether delays in obtaining medications lead to seizure-related complications or hospitalizations.

Our aims of the protocol in this case series study are to review characteristics of headache (i.e. type, timing relative to seizure event, frequency, duration, laterality, quality) and the efficacy of typical therapeutic strategies.

The patient has failed all other available agents and has intractable epilepsy due to Dravet Syndrome. Stiripentol is highly efficacious in Dravet Syndrome. The overall goals of therapy with Stiripentol are primarily to significantly reduce the frequency and severity of seizures.

The purpose of this study is to assess the response of pediatric epilepsy patients to deep brain stimulation.  

The purpose of this study is to see if the microbial environment of the intestines can predict the success of the ketogenic diet for children with medically unmanageable epilepsy.

This study hypothesises that physical exercise in children with epilepsy will be associated with a significant reduction in interictal spikes and a significant reduction in spike burden.

This study aims to determine if vigorous physical exercise results in significant increases or reductions in spike frequency in children on continuous video EEG monitoring.

To investigate the long-term safety and tolerability of clobazam when administered for 1 year as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.

The primary purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in patients treated with TAK-935 as an adjunctive therapy compared to placebo in the Maintenance Period.

The purpose of this study is to provide patients with Dravet Syndrome, who do not qualify for participation in one of the ongoing ZX008 clinical trials, to receive treatment.