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Epilepsy clinical trials

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NCT ID: NCT03059381 Completed - Clinical trials for Primary Generalized Tonic-clonic Seizures

Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adolescence Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures

FYC02T
Start date: August 1, 2016
Phase:
Study type: Observational

The objective of this study is to identify the following in adolescent epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa: 1. unknown adverse drug reactions (ADRs); 2. occurrence of ADRs; 3. factors that are likely to affect safety and efficacy; 4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items; 5. occurrence of psychiatric adverse events as priority investigation items (eg, aggression).

NCT ID: NCT03059329 Completed - Clinical trials for Primary Generalized Tonic-clonic Seizures

Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adult Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures

FYC01S
Start date: August 1, 2016
Phase:
Study type: Observational

The objective of this study is to identify the following in adult epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa: 1. unknown adverse drug reactions (ADRs); 2. occurrence of ADRs; 3. factors that are likely to affect safety and efficacy; 4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items; 5. occurrence of psychiatric adverse events as priority investigation items (eg, aggression).

NCT ID: NCT03052998 Completed - Epilepsy Clinical Trials

Ivermectin Treatment in Patients With Onchocerciasis-associated Epilepsy

OAETREAT
Start date: October 1, 2017
Phase: Phase 4
Study type: Interventional

Many studies have reported an association between epilepsy, including Nodding Syndrome (NS), and onchocerciasis (river blindness). A high prevalence of epilepsy has been noted particularly in onchocerciasis hyperendemic areas where onchocerciasis is not or insufficiently controlled with mass Ivermectin distribution. There is evidence that increasing the coverage of Ivermectin reduces the incidence of epilepsy and anecdotal evidence suggests a reduction in seizure frequency in onchocerciasis associated epilepsy (OAE) patients who receive Ivermectin. Finding an alternative treatment for epilepsy in these patients will have major consequences. Objective To assess whether Ivermectin treatment decreases the frequency of seizures and leads to seizure freedom in OAE patients, including patients with NS. If we are able to demonstrate such an effect this would be an extra argument that Onchocerciasis is causing epilepsy and that therefore we should increase our efforts to eliminate onchocerciasis. Methods We will conduct a randomized clinical trial in the Democratic Republic of Congo (DRC) to compare seizure freedom in onchocerciasis infested epilepsy patients who receive immediate Ivermectin treatment with delayed (after four months) Ivermectin treatment. All participants will simultaneously receive anti-epileptic drugs (AEDs) according to local guidelines for epilepsy treatment. The primary endpoint is seizure freedom defined as no seizures during the fourth month of follow-up. Secondary endpoint is significant (>50%) seizure reduction compared to baseline seizure frequency. Reduction of seizures will be compared between Ivermectin and non-Ivermectin arms. Current status Start of enrolment is planned from March 2017 and we expect to have enrolled all 110 participants by August 2017. Results are expected early 2018. Discussion If Ivermectin treatment, in addition to AEDs, is able to lead to seizure freedom or significantly reduces seizure frequency in OAE patients this will have major consequences for epilepsy treatment in Onchocerciasis endemic regions. Ivermectin is donated for free, and in non Loa-Loa endemic regions has negligible side effects. Reducing the burden of epilepsy will have a major impact on quality of life and socio-economic status of families with affected members in Africa.

NCT ID: NCT03041363 Completed - Epilepsy Clinical Trials

Treatment Development of Triheptanoin (G1D)

Start date: March 29, 2017
Phase: Phase 1
Study type: Interventional

To determine the maximum tolerated dose (MTD), as a percentage of calories consumed, of triheptanoin (C7 oil; C7) in a pediatric and adult patient population genetically diagnosed with glucose transporter type 1 deficiency disorder (G1D).

NCT ID: NCT03021018 Completed - Epilepsy Clinical Trials

A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting

Start date: February 6, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy of intravenous brivaracetam (BRV) compared to intravenous lorazepam (LZP) in subjects with epilepsy undergoing Epilepsy Monitoring Unit (EMU) evaluation who experience seizures that require prompt treatment.

NCT ID: NCT03014752 Completed - Clinical trials for Epilepsy Intractable

Comparison of the Effectiveness of the Outpatient Classical Ketogenic Diet and Modified Atkins Diet on Seizures Frequency, Nutritional Status and Some Biochemical Factors in Children and Adolescents With Intractable Epilepsy

Start date: September 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Epilepsy is one of a common neurological disorder. Antiepileptic drugs (AEDs) are usually the primary treatment of epilepsy. However, almost 30% of patients do not respond to AEDs and other treatments including ketogenic diet (KD) are used. The Ketogenic Diet (KD) is a low-carbohydrate, high fat, adequate-protein diet. In this study, investigators are going to compare two kinds of the ketogenic diet namely classical ketogenic diet and modified Atkins diet. Fifty children and adolescents with intractable epilepsy will be included, 25 patients in each group, and will receive the diet for three months on non-randomised basis. In the classical ketogenic diet, the diet with a ratio of 4 to 1 (4:1), each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced. Classical ketogenic diet will be established on outpatient setting, without fasting and gradually. The modified Atkins diet will be applied by the ratio of 1:1 or 2:1, each 1 or 2 grams of fat to each gram of carbohydrate plus protein.

NCT ID: NCT03000725 Completed - Epilepsy Clinical Trials

Adapting Project UPLIFT for Hispanic Patients With Epilepsy II

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

The purpose of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and depression. Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a home-based intervention that teaches cognitive and mindfulness skills to people with epilepsy by phone to reduce their depression and improve quality of life (QOL); it was developed at Emory University with CDC funding. The purpose of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and depression. Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a home-based intervention that teaches cognitive and mindfulness skills to people with epilepsy by phone to reduce their depression and improve quality of life (QOL); it was developed at Emory University with CDC funding.

NCT ID: NCT02995759 Completed - Epilepsy Clinical Trials

Creation, Implementation, and Analysis of a Seizure Action Plan

Start date: June 2015
Phase:
Study type: Observational

Data strongly suggests that aggressive and early treatment of status epilepticus (SE) is crucial for seizure abortion and prevention of long-term neurologic sequelae. We propose the creation of a seizure action plan, an intervention aimed to guide daily medication use, outline pre-hospital seizure first aid and rescue medication use, and direct emergency personnel in patients' individualized SE medication algorithm, with implementation through the electronic medical record. We hypothesize that the seizure action plan will promote daily medication adherence, increase use of home rescue mediation, and improve timeliness of AED (antiepileptic drug) delivery, length of hospital stay, and ICU admission rate in episodes of status epilepticus.

NCT ID: NCT02993861 Completed - Epilepsy Clinical Trials

Pharmacokinetics of Anti-epileptic Drugs in Obese Children

Start date: December 9, 2016
Phase:
Study type: Observational

The study is a prospective, multi-center, open-label clinical trial. Study's purpose is to characterize the pharmacokinetics and safety of four oral anti-epileptics drugs (levetiracetam, valproic acid [divalproex sodium ER or immediate release formulation if inadequate enrollment}, topiramate, and oxcarbazepine) in a non-randomized sample of obese children and adolescents. The study's duration will be up to eleven days (up to seven days of screening and four days of pharmacokinetic sampling). Eligible participants ages 2 to 18 years will be identified through outpatient clinic schedules and inpatient admissions at each clinic site. Participants receiving at least one of the study drugs per local standard of care will have pharmacokinetic concentrations in plasma drawn according to the specific dosing schedule for each drug. Other study measures include demographics, BMI, waist/hip ratio, medical history, concomitant medication history, documentation of study drug oral intake, adverse effects, and physical examination. The sample size will include 24 participants for each anti-epileptic drug (total 96).

NCT ID: NCT02988050 Completed - Epilepsy Clinical Trials

Conscious Sedation for Epilepsy Surgery

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

Sixty patients were randomly allocated into two groups, group PD and group PR, thirty patients in each group. Patients in PD group received propofol and dexmedetomidine intravenous infusion and patients in PR group received propofol and remifentanil intravenous infusion. Sedation score and patients' satisfaction, surgeon satisfaction, heart rate, mean arterial blood pressure, oxygen saturation, and side effects such as respiratory depression, nausea, vomiting, airway obstruction, and oxygen desaturation were recorded.