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Epilepsies, Partial clinical trials

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NCT ID: NCT03607851 Completed - Focal Epilepsy Clinical Trials

Efficacy and Safety of Rapid Titration Protocols of Lacosamide

Start date: August 3, 2018
Phase: Phase 4
Study type: Interventional

Three different dose titration schedules are tested to find a way to reduce the titration period of lacosamide

NCT ID: NCT03559673 No longer available - Epilepsies, Partial Clinical Trials

Compassionate Use Program With Lacosamide in Patients With Partial-onset or Generalized Tonic-clonic Seizures

Start date: n/a
Phase:
Study type: Expanded Access

The objective of this Compassionate Use Program (CUP) is to provide continued access to Lacosamide (LCM) for monotherapy use for patients who were receiving LCM in SP0993 and SP0994 at the time of study unblinding and close of SP0994, and who benefited from the treatment per investigator assessment.

NCT ID: NCT03478852 Recruiting - Epilepsy Clinical Trials

Investigating Epilepsy: Screening and Evaluation

Start date: March 28, 2018
Phase:
Study type: Observational

Background: Epilepsy affects about 1 percent of the U.S. population. Most people with epilepsy respond well to medicine, but some do not. Researchers want people who have diagnosed or suspected epilepsy to participate in ongoing studies. They want to learn more about clinical care for epilepsy. They want fellows and residents to learn more about the care of people with epilepsy. Objectives: To learn more about seizures and find ways to best treat people with drug-resistant epilepsy. Eligibility: Adults and children ages 8 years and older with diagnosed or suspected epilepsy Design: Participants will be screened with: Physical exam Medical history Questionnaires Participants will have many visits. They may be admitted to the hospital for several weeks. Their medication might be stopped or changed. Participants will have many tests: Blood and urine tests EEG: Wires attached to the head with paste record brain waves. This may be videotaped. Thinking and memory tests MRI: Participants lie on a table that slides in and out of a tube. They perform simple tasks in the tube. MEG: Participants lie on a table and place their head in a helmet to record brain waves. PET scan: Participants lie on a table that slides into a machine. A small amount of radioactive dye is injected into their arm with an IV. For the IV, a small tube is inserted into the arm with a needle. Participants will stay enrolled in this study if they join other epilepsy-related studies. They may be contacted at intervals for follow-up. Their participation will end if they have not been seen clinically for their epilepsy for 3 years.

NCT ID: NCT03457961 Recruiting - Focal Epilepsy Clinical Trials

Post-market Study of AMPA Receptor Antagonists for Epilepsy Patients in Hong Kong

Start date: July 23, 2016
Phase:
Study type: Observational

Background: Epilepsy is a chronic neurological disease which affects approximately 70,000 patients in Hong Kong and 50 billion people worldwide. Among these patients one-third remained unresponsive to antiepileptic agents. Continual drug manipulation is an essential therapeutic option for these patients with refractory epilepsy. In particular, rational polytherapy has become the mainstay of treatment for the sub-group of patients who have failed two or more antiepileptic drugs (AEDs). A substantial amount of research has shown that N-methyl-D-aspartate receptors (NMDA) may play a key role in the pathophysiology of several neurological diseases, including epilepsy. Animal models of epilepsy and clinical studies demonstrate that NMDA receptors activity and expression can be altered in association with epilepsy and particularly in some specific seizure types. NMDA receptor antagonists have been shown to have antiepileptic effects in both clinical and preclinical studies. There is some evidence that conventional antiepileptic drugs may also affect NMDA receptor function. Aims: To investigate the medium to long-term effects of AMPA/NMDA receptor antagonist in an Asian cohort as there is a relative lack of clinical data in this population To explore the efficacy of AMPA/NMDA receptor antagonist in patients with partial onsets seizures that may secondarily generalize and the specific side effects of AMPA/NMDA receptor antagonist in relation to behavioral problems. Methods: A semi-prospective design is adopted to recruit patients who are indicated and started on AMPA/NMDA receptor antagonist aged 12 or above in Hong Kong. This study will collect information about demographic details, medical history and seizure information. Assessment of seizure frequency is based on seizure diary and interviews with family members. Physical examination, electrocardiogram and other medical information relevant to the follow-up of the patient will be collected.

NCT ID: NCT03446664 Completed - Epilepsies, Partial Clinical Trials

Microburst Vagus Nerve Stimulator (VNS) Therapy Feasibility Study

Microburst
Start date: February 27, 2018
Phase: N/A
Study type: Interventional

Evaluate the initial safety and effectiveness of Microburst VNS stimulation in subjects with refractory epilepsy.

NCT ID: NCT03321240 Recruiting - Refractory Epilepsy Clinical Trials

Study of Predictive Biomarkers for Rational Management of Drug-resistant Epilepsy Associated With Focal Cortical Dysplasia

SPREAD
Start date: January 15, 2018
Phase:
Study type: Observational

Focal Cortical Dysplasias (FCDs) are neurodevelopmental disorders that represent a major cause of early onset drug-resistant epilepsies with cognitive and behavioral impairments, carrying a lifelong perspective of disability and reduced quality of life. Despite a major medical and socio-economic burden, rationale therapeutic strategies are still under debate. Surgical removal of the epileptogenic brain area (Epileptogenic Zone) is the most successful treatment, yet it fails to control FCD-associated seizures in as much as 40% of cases. Precise definition and complete resection of the Epileptogenic Zone are the main determinants of outcome. In current practice of French centers, up to 80% FCD-patients require an intracranial EEG (icEEG) recording to accurately define the epileptogenic zone. However, the indications for icEEG in MRI-visible FCD remain empirical and are essentially based on expert opinion.

NCT ID: NCT03283371 Completed - Clinical trials for Epilepsy, Focal Seizures, Partial Seizures

Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy

OPUS
Start date: March 20, 2018
Phase: Phase 2
Study type: Interventional

The primary efficacy objective of the study is to determine if adjunctive therapy of natalizumab 300 mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult participants with drug-resistant focal epilepsy. The secondary efficacy objective is to assess the effects of natalizumab versus placebo in drug-resistant focal epilepsy on additional measures of seizure frequency.

NCT ID: NCT03278210 Recruiting - Focal Epilepsy Clinical Trials

National Study on the Interest of EEG-fMRI in the Presurgical Evaluation of Partial Epilepsies Drug

ENERGY
Start date: April 13, 2011
Phase:
Study type: Observational

The main goal of this study is to evaluate the additional value of EEG-fMRI method in the presurgical evaluation of focal intractable epilepsy. To consider a patient for surgery, the main difficulty is to define accurately the epileptogenic zone. This definition is complex and is often supported by several types of exploration (MRI, FDG PET, neuropsychological testing, video-EEG...). In this study we will evaluate the adding value of the simultaneous recording of EEG and fMRI in the epileptogenic zone definition.

NCT ID: NCT03268824 Recruiting - Pediatrics Clinical Trials

Impact of Epileptic Discharge on the Structural Connectivity of the Developing Brain

EPITRACT
Start date: December 19, 2017
Phase:
Study type: Observational

Focal epilepsy is associated with widespread alterations in structural brain connectivity, often present at the disease onset and related to learning disabilities. Whether ongoing seizure activity contributes to network pathology is a matter of debate. This study intends to measure the impact of seizures on structural connectivity on a local and on a global level. In children examined with intracerebral electrodes to evaluate whether a surgical cure can be proposed, we combine intracerebral stereotactic electroencephalography (EEG) recordings with diffusion weighted imaging of white matter fibers. On the local level, the study will quantify the number of deficient connections in the seizure onset zone. On a global level, the study will compare the white matter fibers of the left and right hemisphere to probe whether physiological language lateralization is preserved.

NCT ID: NCT03244345 Recruiting - Clinical trials for Depression and Epilepsy

Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies

Start date: February 20, 2017
Phase: N/A
Study type: Interventional

Psychiatric disturbances, notably depression, occur frequently as co-morbid conditions with epilepsy. A complex, probably bidirectional relationship between epilepsy and depression has been postulated. Both epilepsy and depression also interact with stressful life events, but only some patients develop these disorders after a stressful event, indicating the possibility of a "vulnerable" population. Animal and human studies have looked at the role of brain derived neurotrophic factor (BDNF) in this context. Low serum and/or CSF levels of BDNF are associated with higher incidence of depression, and thus indicate the vulnerable population. Animal studies of BDNF have looked specifically at the relation between epilepsy and depression using a novel "double hit" design. After chronic stress exposure, measurement of BDNF levels allowed identification of 2 sub-groups: a vulnerable population and non-vulnerable population. A "second hit" of kainic acid induced status epilepticus (SE) was then applied to both the vulnerable and non-vulnerable populations. Only the vulnerable population exposed to SE developed a depression-like profile. In a proof of concept approach we propose studying the relation between epilepsy, depression, anxiety and stressful life events, using serum BDNF levels in patients with pharmacoresistant epilepsy. Evaluation of epilepsy type and co-morbid psychiatric profile will be performed in 150 subjects. By comparing BDNF levels for different epilepsy subgroups to BDNF levels for healthy subjects and for depressed subjects without epilepsy, we hope to identify whether risk of co-morbid depression and/or anxiety in epilepsy may be predicted using BDNF levels. In addition, in a subgroup of 25 patients, we propose a pilot study in which cortisol and C-reactive protein will be measured in addition to BDNF.