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Ultra-high field MRI in DBS for epilepsy

By pre-operatively visualizing the thalamus of DBS patients with epilepsy using 7T MRI, we aim to locate clinically effective and ineffective electrode placement relative to the thalamic subnuclei and its connectivity.

An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome

* To assess the long-term safety and tolerability of ZX008.

A Double-Blind, Placebo-Controlled, Randomized, Single-Center, Cross-Over Study to Investigate the Pharmacodynamic, Pharmacokinetic, Safety, and Tolerability Profiles of Padsevonil in Healthy Study Participants Receiving Either Ethanol or Cannabidiol.

Primary- Part A: Evaluation of pharmacodynamic (PD) interaction between steady-state treatment with padsevonil (PSL) and ethanol- Part B: Evaluation of pharmacokinetic (PK) interaction between steady-state treatment with padsevonil (PSL) and…

OPEN-LABEL, SINGLE-ARM, MULTICENTER, LONG-TERM STUDY TO EVALUATE SAFETY AND EFFICACY OF BRIVARACETAM USED AS ADJUNCTIVE TREATMENT IN PEDIATRIC SUBJECTS WITH EPILEPSY;P/297/2019 (POS indication)

Primary objective* To document the long-term safety and tolerability of BRVSecondary objective* To assess the efficacy of BRV during long-term exposureOther objectives* To explore direct cost parameters* To assess the effect of BRV on behavior using…

Effects of sodium lactate infusion in patients with glucose transporter 1 deficiency syndrome (GLUT1DS)

The purpose of this explorative study is to investigate whether treatment with lactate has any positive effect on the symptoms of GLUT1DS, especially the drug-resistant epilepsy.Primary Objective: - To assess changes in EEG during and shortly after…

Evaluation of ANT-DBS Neuromodulation with Sensing Electrodes (EANSkE)

The primary goal of the study is to identify biomarkers from LFPs recorded from the DBS electrodes that are associated with treatment response to DBS in patients with epilepsy. If these biomarkers exist, these can potentially be used to guide…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study to Examine the Efficacy and Safety of ZX008 in Subjects with CDKL5 Deficiency Disorder Followed by an Open-Label Extension

This study has been transitioned to CTIS with ID 2023-506269-78-00 check the CTIS register for the current data. Objectives for Part 1: Primary (Efficacy): To demonstrate that the efficacy of fenfluramine (ZX008) 0.8 mg/kg/day is superior to placebo…

A double-blind, randomized, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P, CBD) as add-on therapy in patients with tuberous sclerosis complex who experience inadequately-controlled seizures

Primary Objective Blinded Phase:• To evaluate the efficacy of GWP42003-P as add-on therapy in reducing the frequency of seizures when compared with placebo in patients with TSC.Open-label Extension:• To evaluate via the adverse events (AE) profile…

Paired pulse TMS-EEG in epilepsy: improving the evaluation of therapeutic efficacy

The primary objective of this study is to evaluate differences in motor evoked potential (MEP) and TMS evoked potential (TEP) to paired pulse TMS between epilepsy patients with a successful response to AEDs and those who do not (refractory patients…

A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2)

The primary efficacy objectives of this two-cohort study are:o To demonstrate that ZX008 is superior to placebo as adjunctive therapy in the treatment of symptoms of Dravet syndrome in children and young adults based on change in the frequency of…

A multicenter, open-label, parallel-group study in study participants with epilepsy to evaluate the effect of oxcarbazepine on the pharmacokinetics, safety, and tolerability of padsevonil.

The primary objective of this study is to evaluate the effect of stable coadministered OXC (as monotherapy or adjunctive therapy) on the PK of PSL in study participants with epilepsy compared with study participants co-medicated with stable doses of…