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Epilepsy clinical trials

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NCT ID: NCT04639310 Terminated - Epilepsy Clinical Trials

XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy

EPIK
Start date: March 29, 2021
Phase: Phase 3
Study type: Interventional

To investigate the potential antiseizure effects of adjunctive XEN496 (ezogabine) compared with placebo in children with KCNQ2 Developmental and Epileptic Encephalopathy (KCNQ2-DEE).

NCT ID: NCT04610879 Terminated - Rolandic Epilepsy Clinical Trials

Changing Agendas on Sleep, Treatment and Learning in Epilepsy

CASTLE
Start date: August 2, 2019
Phase: Phase 4
Study type: Interventional

Rolandic epilepsy (RE) is the most common type of epilepsy. Children with RE have seizures and can often find that their learning, sleep, behaviour, self-esteem and mood are affected. As part of standard NHS care, children diagnosed with RE may be treated with standard anti-epileptic medicines, like carbamazepine, or no medicine at all. The medicines used to treat epilepsy often slow down a child's thinking and learning. In the past, doctors believed this was an acceptable price to pay to reduce seizures. However, with RE, where the seizures usually stop in teenage years, investigators do not know if it is better to treat these children with medicines or not, especially if the medicines might have a negative effect on their learning. A newer medicine called levetiracetam has also been found to work in children with RE and has shown less problems with thinking and learning in adults. However, it is still no known if this is also the case for children and it has not been proven which of the three options (carbamazepine, levetiracetam or no treatment) would be best for RE patients. The CASTLE study aims to find this out. In addition, it has been found that seizures often happen when a child has had poor sleep and they often come at night or early in the morning. It has been shown that sleep can be improved through practice without the need of medicines. There are established guidelines to help toddlers go to sleep, but nothing available that helps young people with epilepsy and their parents improve their sleep quality. In the CASTLE study, a sleep training plan has been developed for children with epilepsy and the trial aims to find out whether following this sleep training plan results in less seizures than using no sleep training at all.

NCT ID: NCT04607317 Terminated - Epilepsy Clinical Trials

Exercise as Adjunctive Treatment for Refractory Epilepsy

Start date: April 13, 2021
Phase: N/A
Study type: Interventional

The purpose of this research study is to determine whether a 12-week telehealth aerobic exercise intervention is feasible in people with epilepsy. The study team will also gather information on the effect of the intervention on sleep and stress as mediators of seizure frequency, well as effects on epilepsy and epilepsy associated comorbidities.

NCT ID: NCT04537832 Terminated - Dravet Syndrome Clinical Trials

Natural History Study of Infants and Children With Developmental and Epileptic Encephalopathies

ENVISION
Start date: January 18, 2021
Phase:
Study type: Observational

This is a multicenter, prospective, 2-year observational study in infants and children with developmental and epileptic encephalopathies (DEEs). The DEE currently being investigated is SCN1A-positive Dravet Syndrome.

NCT ID: NCT04529954 Terminated - Focal Epilepsy Clinical Trials

Anti-Epilepsy Medication Valproate Administered Via ICV Route and Catheters and Pumps for CSF Infusion

Start date: January 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a non-randomized open-label extension study for subjects having completed protocol DA071976 or CLN100P.01.

NCT ID: NCT04398667 Terminated - Refractory Epilepsy Clinical Trials

European Non-interventional Study on Refractory Epilepsy With Developmental Delay

Start date: March 14, 2019
Phase:
Study type: Observational

This is a multinational, multicentre, non-interventional, retrospective data collection (manual Medical Chart Review).

NCT ID: NCT04266990 Terminated - Epilepsy Clinical Trials

Olfactive Discriminative Ability of Dogs When Confronted With Seizure and Non-seizure Samples // Identification of Potential Biomarkers for Epilepsy in Human Sweat.

Start date: January 20, 2020
Phase: N/A
Study type: Interventional

Dogs belonging to MDD will be trained and asked to discriminate between odour sweat samples from epilepsy patients associated with a seizure ("seizure sample") and samples collected when no seizure was close in time ("non-seizure sample"). The same type positive and negative sweat samples will be analysed by Florida International University using solid phase micro extraction (SPME) GC-MS to try to identify volatile organic components (VOC) specific to the samples associated with seizures.

NCT ID: NCT04095247 Terminated - Epilepsy Clinical Trials

Does Pulse-triggered VNS Autostimulation Increase VNS Efficacy

ERAS
Start date: April 3, 2018
Phase:
Study type: Observational

This is a research study to investigate whether the use of an extra function of vagus nerve stimulator (VNS) can give an improved effect against epilepsy. Many epileptic seizures are accompanied by an increase in heart rate. One auxiliary function of a new type of stimulator is continuous measurement of cardiac activity, and when pulse rate increases an extra stimulation is delivered. It has been shown that this can interrupt attacks that are about to develop. In this project the investigators will test how well that works for patients in daily life. The new type of stimulator has similar design and location as the old one. Patients who have already been treated with VNS and who need to switch the stimulator because the battery is starting to run out, are asked whether they want to participate. The study is a randomized and blinded cross-over. The activation of the extra feature is done either in the first or the second treatment phase. Which phase is the phase with activated autostimulation will be decided by random selection and the patient does not know when the auxiliary function is started. The study period is 11 months. Patients are asked to fill in some questionnaires on seizures, quality of life and quality of sleep.

NCT ID: NCT03955432 Terminated - Focal Epilepsy Clinical Trials

Long-term Cardiac Monitoring in Epilepsy

LOOP
Start date: March 19, 2019
Phase: N/A
Study type: Interventional

The purpose of this research study to investigate, classify, and quantify chronic cardiac rhythm disorders in three groups of patients with epilepsy (intractable focal epilepsy, controlled focal epilepsy and symptomatic generalized epilepsy). Patients with epilepsy have a higher risk for cardiac complications than the general population. With this study, we aim to understand more about these potential complications in patients with epilepsy and assess if treatments for cardiac problems should be evaluated more carefully in patients with epilepsy.

NCT ID: NCT03886753 Terminated - Cancer Clinical Trials

Pharmacokinetic (PK) and Pharmacodynamics (PD) Study of Ilera Specific Products

Ilera
Start date: May 15, 2019
Phase:
Study type: Observational

This is an observational study of medical marijuana manufactured and dispensed by Ilera and given as standard treatment for a variety of approved serious medical conditions as defined by individual state law. All patients who are receiving one of the four formulations (Dream, Soothe, Shine and Ease) of medical marijuana will be provided a study flyer and asked to contact the study team via phone or email. Once the study team confirms eligibility, the study team will meet the subject face-to-face most likely at their dispensary (or other mutually agreeable location) and obtain informed consent, and assent when appropriate. Initial baseline demographic information, medical history and medication inventory will be completed. Also, since it is possible that the Investigators will enroll subjects across the region, Investigators anticipate the need to seek consent over the phone for many patients. This will be done via Skype, Go to Meeting, Facetime or similar platforms so that the Investigators can have a face to face interaction with the potential subjects. Regardless of where this discussion takes place (i.e., in person or via the web), all reasonable safeguards to ensure patient privacy will be taken. Patients or their legally authorized representative (LAR) will be given sufficient (i.e., up to several hours/days) to make a decision to participate in this study. Study staff will fax or email the consent form for their signature and no study procedures will begin until the signed consent form is received by the study team. The subjects or their LARs will be instructed on obtaining the blood samples. Blood draws will be completed in the subjects' home after one of their standard doses is taken.