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Seizures clinical trials

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NCT ID: NCT02544750 Completed - Seizures Clinical Trials

An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)

Start date: August 31, 2016
Phase: Phase 3
Study type: Interventional

This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.

NCT ID: NCT02535572 Completed - Depression Clinical Trials

Focal Electrically-Administered Seizure Therapy (FEAST) Studies at Two Enrolling Sites to Further Test and Refine the Treatment

FEAST
Start date: August 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This open label investigation further evaluates the safety, efficacy and potential mechanisms of action of a new form of electroconvulsive therapy (ECT). The investigators have recently completed preliminary open-label studies with FEAST, first at Columbia University, and then at the Medical University of South Carolina in Charleston (Nahas et al., 2013b). The investigators have published the outcomes of the first 17 patients studied. One patient withdrew from the study after a single titration session. After the course of FEAST (median 10 sessions), there was a 46.1 + 35.5% improvement in Hamilton Rating Scale for Depression (HRSD24) scores compared to baseline (33.1 + 6.8, 16.8 + 10.9; P < 0.0001). Eight of 16 patients met response criteria (≥50% decrease in HRSD24) and 5/16 met remission criteria (HRSD24≤10). Patients achieved full re-orientation (4 of 5 items correct) in 5.5 + 6.4 min (median time = 3.6 min), timed from when their eyes first opened after treatment. The investigators have now studied 18 more patients (see results below), and we are completing the study in the original IDE with another two more patients still to enroll. This work allowed us to refine the treatment. For example, the investigators selectively modified the electrode geometry to decrease interelectrode resistance. Additionally the investigators modified the titration schedule, now only administering a standard 800 ma ultrabrief pulse, and thus no longer titrating in the current domain. In this next proposed trial we will continue to gather efficacy and safety data, and compare these to a parallel non-randomized group receiving ECT standard of care. ECT is typically delivered in a dynamically adaptive manner, with each person having a different number of treatments, averaging between 8-12 treatment over 4-5 weeks. We thus have to use imprecise time points such as 'at the end of the acute treatment course' rather than specified dates or visits.

NCT ID: NCT02535091 Completed - Partial Epilepsy Clinical Trials

Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

Start date: August 3, 2016
Phase: Phase 3
Study type: Interventional

This 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 (AED) other than phenytoin and phenobarbital to further investigate long-term safety.

NCT ID: NCT02484001 Completed - Epilepsy Clinical Trials

Eslicarbazepine Acetate (BIA 2-093) as Monotherapy in Patients With Newly Diagnosed Partial-onset Seizures

Start date: March 1, 2016
Phase: Phase 3
Study type: Interventional

This is a Phase III, multinational, open-label, non-controlled study with subjects under treatment in the double-blind BIA-2093-311 study (NCT01162460). Subjects will enter the open-label extension study after the preceding double-blind study was unblinded and they are attending their last Extension Phase Visit (EPV) of the double-blind study. For all subjects, the day of the last EPV of the double-blind study will also be the day of Visit 1 for the open-label extension study. All subjects will receive Eslicarbazepine acetate (ESL) under open-label conditions at Visit 1. The complete study duration including treatment with ESL under open-label conditions and follow-up is expected to last approximately 2 years (105 weeks). In case ESL as monotherapy will achieve MA prior to the end of 2017, the study may be discontinued prematurely within 42 days after achievement of MA.

NCT ID: NCT02477839 Completed - Clinical trials for Epilepsy With Partial-onset Seizures

Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures

Start date: June 5, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to assess the efficacy, safety and tolerability of lacosamide administered as add-on therapy with 1 to 3 anti-seizure medications. This trial is for children aged 1 month to less than 4 years with epilepsy who currently have uncontrolled partial-onset seizures.

NCT ID: NCT02469844 Completed - Epilepsy Clinical Trials

Heart Rate Variability (HRV) Analysis in Patients With Nocturnal Epileptic Seizures

Start date: October 2014
Phase:
Study type: Observational

Epilepsy is disabling and costly to patients and the health service. Nearly 400,000 people in England suffer from epilepsy. About 40% of these patients are known to have seizures predominantly in sleep. All seizures pose risk to the individual both physical and psychological. Nocturnal seizures pose extra risk as the diagnosis may be missed or delayed. Patients with nocturnal seizures are also thought to be at particular risk of sudden unexpected death in epilepsy (SUDEP), especially if their seizures are unobserved. In patients with poor seizure control, the risk of SUDEP has been found to be as high as 9 per 1,000 patient years. Previous studies show that many seizures are associated with changes in the Autonomic Nervous System (ANS) tone. The ANS tone can be assessed using heart rate variability parameters (HRV). A few studies suggest that ANS tone changes tend to precede the onset of epileptic seizure related surface electroencephalographic (EEG) changes, suggesting that ANS tone changes could be used in seizure alarm or intervention systems. This prospective study intends to focus on seizures from sleep and study HRV parameters in the immediate preictal state of the seizure and compare these with resting HRV parameters in the same patient with the aim of finding HRV metrics which could help to identify the presence of seizures in longterm electrocardiographic (ECG) recordings, or help predict seizure occurrence, or provide information about the current risk of seizures. This study will also investigate whether there are differences in the alterations of HRV parameters between different forms of epilepsy and whether seizure lateralisation has an impact on HRV parameters.

NCT ID: NCT02465047 Completed - Epilepsy Clinical Trials

Stress and Seizures - Can a Brief Self-help Book Help?

Start date: November 2014
Phase: N/A
Study type: Interventional

Background: Epilepsy and nonepileptic attack disorder (NEAD) are chronic conditions that cause many patients to experience a great degree of stress in their everyday lives. Patients have also reported stress as the commonest trigger of their seizures, and animal studies suggest that stress can make seizures worse. A self-help intervention that would help people manage the stress they experience could therefore improve their quality of life and have positive effects on the frequency of their seizures. Research Question: The study evaluates whether a self-help intervention in the form of a brief booklet can improve the quality of life and reduce the levels of stress of people who experience seizures. In addition, the study will explore the associations between seizure severity and frequency, physiological and self-reported stress, and anxiety and depression. Design: The researchers are recruiting patients attending the Outpatient Neurology Clinic at the Royal Hallamshire Hospital and measure their quality of life and stress levels before, one month and two months after they have been given the self-help stress reduction booklet. The researchers will measure the changes in quality of life and stress levels using questionnaires and saliva samples.

NCT ID: NCT02458820 Completed - Seizures Clinical Trials

Prompt Diagnosis and Treatment of Subclinical Seizures After Cardiac Arrest

Start date: June 2015
Phase: N/A
Study type: Interventional

Non-convulsive seizures (NCS) following cardiac arrest are common and are associated with worse neurologic outcomes and increased mortality. More prolonged seizures (status epilepticus) are associated with worse outcomes. Earlier diagnosis and treatment of seizures may lead to earlier termination of seizures and decreased seizure burden. This study will evaluate whether bedside intensive care unit (ICU) provider interpretation of a type of EEG called DSA EEG can be used by non-neurologists to diagnosis seizures more rapidly than continuous EEG's routinely read by neurologists.

NCT ID: NCT02431780 Completed - Epilepsy Clinical Trials

A Multicentre Clinical Investigation of a Decision Support Algorithm for Neonatal Seizure Detection

ANSeR
Start date: February 12, 2015
Phase: N/A
Study type: Interventional

The ANSeR Clinical Investigation is a multi-centre, randomised, controlled, clinical investigation of a standalone decision support Algorithm for Neonatal Seizure Recognition, the ANSER Software system.

NCT ID: NCT02426047 Completed - Epilepsy Clinical Trials

Medium Chain Triglycerides as an Adjunct to the Modified Atkins Diet for Women With Catamenial Epilepsy

Start date: March 2015
Phase: N/A
Study type: Interventional

The modified Atkins diet (MAD) has been shown to be effective in treating intractable epilepsy. Approximately 55% of the patients started on the diet are women of childbearing age and women with epilepsy often have a pattern of seizures that correlates with their menstrual cycle, called catamenial epilepsy. The investigators have observed that despite an overall reduction in seizure frequency, some women on the MAD continue to have breakthrough seizures in a catamenial pattern. The investigators hypothesize that women with a history of intractable epilepsy who have been on the modified Atkins diet for at least 3 months and have a catamenial seizure pattern will tolerate and be compliant with the addition of a daily amount of betaquik® (a liquid emulsion of medium chain triglycerides) for a 10 day time interval starting 2 days prior to and encompassing the primary catamenial pattern.