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Epilepsy clinical trials

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NCT ID: NCT02513992 Withdrawn - Epilepsy Clinical Trials

Ictal SPECT With Intra-arterial Injection

Start date: May 2016
Phase: N/A
Study type: Interventional

Ictal SPECT with intravenous injection in a cubital vein of a perfusion tracer is an established technique to localize the ictal onset zone during presurgical evaluation of refractory focal epilepsy. When seizures last less than 10 seconds, localizing information is often not obtained. Since it takes around 30 seconds before the tracer reaches the brain after intravenous injection, ictal hyperperfusion most likely has already switched to postictal hypoperfusion. In this study, we plan to inject the perfusion tracer in the aorta proximal to the cerebral arteries, which will allow a true ictal injection in patients with seizures of short duration.

NCT ID: NCT02497443 Completed - Epilepsy Clinical Trials

Safety of Autologous MSC Infusion to Treat Epilepsy

AMSCDRSE
Start date: April 2011
Phase: Phase 1/Phase 2
Study type: Interventional

• The goal of this study was to evaluate the safety and efficacy of autologous MSC application for the therapy of drug-resistant symptomatic epilepsy. Adult (18-60 years old) patients (pts) of both sexes suffering from refractory epilepsy with frequent (>5 events per month) seizures were included in this study. The pts were randomized to the standard treatment with anti-epileptic drugs (control group, 30 pts) or anti-epileptic drugs plus autologous mesenchymal stem cells (MSCs) (study group, 30 pts). The pts in the study group received one intravenous injection of ex vivo expanded MSCs (40-101 x 106 cells) and one subsequent endolumbal injection of neuroinduced MSCs (2.7 - 8.0 x 106 cells). Both the unfavorable reactions to MSC infusions and the clinical effects, including complications, were examined. The unfavorable reactions to the MSC injections included local pain or hemorrhage at the site of injection and systemic reactions of the central nervous system (CNS; i.e., hyperthermia, fatigue, and myalgia).The possible beneficial effects of therapy in the two groups of pts were examined based on clinical observations and electroencephalography measurements (prior and 12 months after the application of the MSC-based therapy). To determine potential changes in disease progression, the signs of cognitive impairment, behavioral disorders, and particularly, changes in seizure character and frequency were evaluated using the National Hospital Scale of Seizure Severity. The main points of disease monitoring were "yes" or "no" responses (to therapy), seizure frequency (per month), and remission of disease. Electroencephalography (EEG) recordings were performed to evaluate electrical alpha, beta, theta and delta waves based on standard and additional criteria. The paroxismality index, the peak frequency of EEG activity, the index of slow activity, and the summarized points of EEG pathology signs were calculated for each patient. All assessments were performed for the pts in the control and study groups, and the obtained data were compared to identify the potential differences between the two pts groups. Therapy was terminated when immediate unfavorable reactions to the MSC injections were observed. The final observation of each patient included clinical and EEG assessments at the time point of 12 months (or more) after the application of the MSC-based therapy.

NCT ID: NCT02497235 Completed - Epilepsy Clinical Trials

A Phase 1 Positron Emission Tomography Study to Measure Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935

Start date: July 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the brain cholesterol 24S-hydroxylase (CH24H) enzyme occupancy of TAK-935 after single oral dose in healthy participants using the positron emission tomography (PET) ligand [18F]MNI-792 and PET imaging and to determine the relationship of occupancy to TAK-935 exposure.

NCT ID: NCT02497105 Completed - Epilepsy Clinical Trials

Ketogenic Diet Program for Epilepsy

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

This study will assess the effectiveness of the ketogenic diet (high-fat, low-carbohydrate, and moderate protein) in treating epilepsy. Two study groups will be comprised of children with epilepsy (0-18 years of age) and whether or not they receive the ketogenic diet - epilepsy/ketogenic diet and epilepsy/non-ketogenic diet.

NCT ID: NCT02495844 Completed - Clinical trials for Highly Drug-resistant Focal Epilepsy

A Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy

Start date: July 2015
Phase: Phase 2
Study type: Interventional

This study is to assess the efficacy, safety, and tolerability of the investigational drug UCB0942in adult subjects with drug-resistant focal epilepsy across multiple centers in Europe.

NCT ID: NCT02491476 Completed - Epilepsy Clinical Trials

Recording "Fast Ripples" Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy

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

The main objective of this study is to evaluate the feasibility of recording fast-ripples, a potential new biomarker of epilepsy, using the new micro-macroelectrodes developed by Dixi-Medical.

NCT ID: NCT02491073 Completed - Epilepsy Clinical Trials

Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL)

Start date: September 2015
Phase: N/A
Study type: Observational

The purpose of this research study is to determine if the blood tests used to measure free thyroid hormone levels are affected by a drug called eslicarbazepine acetate. To determine if eslicarbazepine acetate interferes with these blood tests, blood samples will be analysed so that researchers can compare different types of lab tests that measure these thyroid hormones. Half of the people who participate in this study will already be taking eslicarbazepine acetate either as a study drug or as a prescription (Part 1) and the other half will be people who do not take eslicarbazepine acetate (Part 2).

NCT ID: NCT02485756 Completed - Epilepsy Clinical Trials

Counseling on the Interaction of Hormonal Contraceptives and Antiepileptics

Start date: June 2013
Phase: N/A
Study type: Interventional

Previous studies have shown that women on anti-seizure medications are not informed about the pharmaceutical drug interactions between anti-seizure medications (antiepileptic drugs, AEDs) and certain hormonal contraceptive. The goal of this proposed study is to develop and assess the efficacy of an educational handout for participants on the ways AEDs and certain hormonal contraceptives can interact to alter effectiveness of the medications. Reproductive age women (18-45 years old) will be recruited from UCSD Health System Epilepsy clinics. If a patient agrees to participate, she will be given a knowledge exam prior to the clinic appointment to establish baseline understanding of hormonal contraceptive and AED interactions and then the participant will be randomized to receive the intervention (educational handout) or the standard of care (no educational handout). Those in participants in the intervention group will read an educational handout on hormonal contraceptives/AED interactions. Those in the standard care group will not receive this handout and the same knowledge exam will be re-administered to all of the participants after they have completed their appointments to check for knowledge comprehension and short-term knowledge retention. A same-day post-test questionnaire will evaluate participant's intention to discuss hormonal contraceptives/AED interactions with their gynecologist, neurologist or primary care physician.

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.