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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…

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…

Distinguishing children with frontal epilepsy from children with ADHD in terms the cognitive profile.

Distinguishing frontal lobe epilepsy from ADHD in terms of working memory.

Learning, Memory and Networks in the Human Brain: Single Neuron Recordings in Depth-electrode Candidates for Epilepsy Surgery

The first goal of the present study is to elucidate the network topology of the MTL on both large-scale and micro-scale levels with the aim of further understanding epilepsy related changes to the network structure. Additionally we will also use the…

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…

Stimulation of the anterior thalamic nucleus in refractory epilepsy:
Neurophysiological aspects and effects on cognition

Primary Objective: - To gain insight on the underlying mechanisms of the variability of the response to ATN-DBS in patients with AED refractory epilepsySecondary Objective(s): - To gain insight in the neurophysiology of the anterior thalamic nucleus…

SCN1A-related seizure disorders: prediction of clinical course based on advanced genotyping

The objective of the study is to investigate if it is possible to predict the clinical outcome of a patient with SCN1A related epilepsy based on the findings of advanced genotyping. We aim to answer the following questions:1. Can clinical outcome in…

The 'Livassured' Combined Sensor system to detect Epileptic Noctural SEizures (LICSENSE)

The primary objective of this trial are to assess the clinical usefulness (in terms of sensitivity and positive predictive value of 1. Combined heart rate and movement detection2. And the added value of video and audio detection in a population of…

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.

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…

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…

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…

Non-Invasively recorded high frequency oscillations as biomarkers in focal epilepsy

Primary objective of this study is to improve identification of epileptic HFOs in EEG and MEG, by comparing them to HFOs in corticography. Secondary objectives are to study the predictive value of non-invasively recorded HFOs for disease activity…

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…

SINGLE CENTER, OPEN LABEL, RANDOMIZED TWO-WAY CROSSOVER STUDY OF THE EFFECT OF LACOSAMIDE 200MG TWICE DAILY ON THE SINGLE-DOSE PHARMACOKINETICS AND PHARMACODYNAMICS OF WARFARIN (25 MG) IN HEALTHY MALE VOLUNTEERS

Primary objective:The primary objective of this study is to evaluate the effect of LCM 200mg bid on the single dose PK and PD of a single warfarin 25mg dose.Secondary objective:The secondary objective of this study is to monitor the safety and…

A three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures

Primary: To compare the reduction in frequency of partial-onset seizures on each of two trough ranges of everolimus (3-7 ng/mL and 9-15 ng/mL) versus placebo in patients with TSC who are taking one to three AEDs. Key secondary: Ability to completely…

Cardiac Arrhythmias in Refractory Epilepsy: identifying prevalence and LINKage between seizures and arrhythmias (CARELINK)

Primary objective:To assess the two-year prevalence and incidence of clinical relevant arrhythmias in drug-resistant epilepsy.Secondary objective:To assess whether the recorded cardiac arrhythmias are related to epileptic seizures (subjectively from…

A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 4 -16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES

The primary objective of this study is to evaluate the efficacy of 2 dose levels of pregabalin (Level 1: 2.5 mg/kg/day; maximum 150 mg day and Level 2: 10 mg/kg/day; maximum 600 mg day) compared to placebo as an adjunctive treatment in reducing the…