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A PHASE 1, OPEN-LABEL, PHARMACOKINETIC TRIAL TO INVESTIGATE POSSIBLE DRUG-DRUG INTERACTIONS BETWEEN CLOBAZAM, STIRIPENTOL OR VALPROATE AND CANNABIDIOL (GWP42003-P) IN HEALTHY SUBJECTS

During this study it will be investigated what the effect is of multiple doses of CBD on the absorption and elimination from the body (this is called pharmacokinetics) of clobazam, stiripentol or valproate. It will also be investigated what the…

Dietary treatment of children with Angelman Syndrome and refractory epilepsy

Primary objective: - 50% seizure reduction or more at 3 months of dietary treatment .Secondary objectives: -level of ketosis on KD and MAD.-number of patients maintaining >50% seizure reduction on MAD.-number of withdrawals (not able to…

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SAGE-547 INJECTION IN THE TREATMENT OF SUBJECTS WITH SUPER-REFRACTORY STATUS EPILEPTICUS

Primary objective:To determine the response to a 144-hour (6 day) continuous intravenous infusion of SAGE-547 compared to placebo administered to support the weaning of all third-line agents in subjects with SRSE, and for the response to endure at…

The Effects of Transcutaneous Vagus Nerve Stimulation on the Pupil Diameter, Heart Rate and Heart Rate Variability in Epilepsy Patients and Healthy Subjects.

Primary objective: The main objective of this pilot study is to gain more insight into the effects of tVNS: to assess if the ABVN and consecutively the NTS are really stimulated by tVNS. Therefore this study investigates the effects of tVNS on the…

A 12-MONTH OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC SUBJECTS 1 MONTH TO 16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES AND PEDIATRIC AND ADULT SUBJECTS 5 TO 65 YEARS OF AGE WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES

To evaluate the long-term safety and tolerability of pregabalin in pediatric subjects 1 month through 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with (PGTC) seizures.

TimeToStop (TTS) Trial, A randomized controlled trial of cognitive consequences of early versus late antiepileptic drug withdrawal after pediatric epilepsy surgery

Primary Objective: To assess whether early postoperative AED withdrawal improves cognitive function compared to late withdrawal.Secondary objectives: * To confirm safety of earlier AED withdrawal; we will assess eventual seizure freedom, seizure…

A double-blind, randomized, placebo-controlled study of the efficacy, safety/tolerability, and pharmacokinetic profile of UCB0942 in adult patients with highly drug-resistant focal epilepsy

To assess the efficacy as well as the safety and tolerability of an investigational drug called UCB0942 that will be given in addition to the current epilepsy treatment of the patient.

Randomized, double-blind, double-dummy, placebo-controlled, four-way crossover single dose
study to determine the test-retest reliability of, and the effect of oral valproic acid, levetiracetam and
lorazepam on, cortical excitability measurements in healthy volunteers as measured by TMS-EEG and TMS-EMG.

Primary Objective- To investigate the ability of TMS-EEG measures to detect effects on cortical excitability of valproic acid, levetiracetam and lorazepam in healthy subjects- To investigate the ability of TMS-EMG measures to detect effects on…

A phase 2, double-blind, randomized, placebo-controlled pharmacokinetic trial in two parallel groups to investigate possible drug- drug interactions between stiripentol or valproate and GWP42003-P in patients with epilepsy.

Primary Objective: To determine whether GWP42003-P affects the pharmacokinetic (PK) profile of stiripentol (STP) or valproate (VPA).Secondary Objective: To assess the safety and tolerability of GWP42003-P in the presence of STP or VPA.To assess…

An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes

To evaluate the long term safety and tolerability of GWP42003-P, as adjunctive treatment, in children and adults with inadequately controlled DS or LGS.All Patients:To evaluate the effect of GWP42003-P, as adjunctive treatment, on:* Quality of life…

A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.

To assess the efficacy of GWP42003-P as an adjunctive antiepileptic treatment compared with placebo, with respect to the percentage change from baseline during the treatment period of the study in convulsive seizure frequency. The dose response…

Pharmacokinetic and pharmacodynamic modelling of routinely used off label drugs in premature neonates

Recently, population PK/PD modeling and simulation studies have enabled the development of evidence-based individualized dosing schemes for children with a limited number of subjects, thus improving drug safety and efficacy. The application of PK/PD…

Randomised open label cross-over study into the efficacy of RApamycin in children with Tuberous sclerosis complex with intractable Epilepsy

In our study we aim to find proof-of-concept that influencing the underlying protein dysfunction can result in clinically relevant improvement of epilepsy.

Effectiveness of verapamil in patients with carbamazepine-resistant epilepsy

Evaluation of the efficacy and tolerability of adding verapamil to the antiepileptic drug regimen in patients who did not become seizure free on carbamazepine.

A single-center, open-label study of excretion balance, pharmacokinetics, and metabolism of 14carbon-labeled UCB0942 after 100 mg single oral dose administration in healthy male subjects

Primary:- to determine the excretion balance and the PK of total radioactivity in 6 healthy male subjects following a single oral dose of UCB0942Secondary:- to identify and quantify metabolites of UCB0942- to gain further information on the PK,…

Cost-effectiveness of a ketogenic diet in children with intractable epilepsy: a Dutch randomized controlled trial

Primary Objective: To demonstrate the cost-effectiveness of treatment with a ketogenic diet compared to usual care in children with drug-resistant epilepsy who are not eligible for epilepsy surgery. Usual care is defined as: the child continuous to…

A Phase I, open-label, randomized, 2-panel, sequential treatment study in healthy subjects to investigate the potential pharmacokinetic interactions between multiple doses of phenytoin or carbamazepine and telaprevir at steady-state

OBJECTIVES AND HYPOTHESISPrimary ObjectivesThe primary objectives are to determine- the effect of steady-state telaprevir 750 mg every 8 hours (q8h) on the multiple dose pharmacokinetics ofphenytoin 200 mg every 12 hours (q12h) in healthy subjects,…

A double-blind, placebo-controlled, dose-escalation, parallel-group study to evaluate the efficacy and safety of E2007 (perampanel) given as adjunctive therapy in subjects with refractory partial seizures.

Primary Objective: The primary objective is to evaluate the efficacy of 2 doses ofperampanel (8 and 12 mg) in comparison to placebo given as an adjunctive therapy insubjects with refractory partial seizures.Secondary Objective: The secondary…

Biochemical implications of ketogenic diet in children with intractable epilepsy: a metabolimics approach.

Because the ketogenic diet has a large impact on daily life of both patient and parents/caretakers, it would be a great improvement if one would be able to predict the effectiveness at a much earlier stage. We hope to be able to trace mechanisms by…

A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P; CBD) as adjunctive treatment for seizures associated with Lennox- Gastaut syndrome in children and adults

Primary objective: To evaluate the efficacy of GWP42003-P as adjunctive treatment inreducing the number of drop seizures when compared with placebo, inpatients with LGS.Drop seizure is defined as an attack or spell (atonic, tonic or tonic-clonic)…