A5075049254- Epilepsy research and treatment
- Pharmacological Effects and Toxicity Studies
- Parkinson's Disease Mechanisms and Treatments
- Pharmaceutical studies and practices
- Neuroscience and Neuropharmacology Research
- Attention Deficit Hyperactivity Disorder
- Botulinum Toxin and Related Neurological Disorders
- Neonatal and fetal brain pathology
- Neurotransmitter Receptor Influence on Behavior
- Cardiac Arrhythmias and Treatments
- Antibiotics Pharmacokinetics and Efficacy
- Restless Legs Syndrome Research
- Drug Transport and Resistance Mechanisms
- Advancements in Transdermal Drug Delivery
- Neurological disorders and treatments
- Bipolar Disorder and Treatment
- Ginkgo biloba and Cashew Applications
- Electroconvulsive Therapy Studies
- Anesthesia and Sedative Agents
- Analytical Methods in Pharmaceuticals
- Neonatal Health and Biochemistry
- Cardiac pacing and defibrillation studies
- Cardiac electrophysiology and arrhythmias
- Treatment of Major Depression
- Metabolism and Genetic Disorders
UCB Pharma (Germany)
2009-2024
UCB Pharma (Belgium)
2012-2024
Ibero American University
2015
Universität Hamburg
2004-2005
University Medical Center Hamburg-Eppendorf
2004-2005
University of Tennessee at Knoxville
2003
Abstract Objective To evaluate the pharmacokinetics, safety, and tolerability of brivaracetam (BRV) as 15‐min intravenous (IV) infusion bolus (≤2‐min injection). Methods EP0065 (ClinicalTrials.gov: NCT03405714) was a Phase 2, multicenter, open‐label trial in patients ≥1 month to <16 years age with epilepsy. Patients received up 5 mg/kg/day BRV (not exceeding 200 mg/day). Enrollment sequential by descending age, depending on safety review. Outcomes included plasma concentrations before...
Rotigotine is a dopamine receptor agonist with activity across the D1 through to D5 receptors as well select serotonergic and adrenergic sites; continuous transdermal delivery of rotigotine replacement patch once daily maintains stable plasma concentrations over 24 h. indicated for treatment early advanced-stage Parkinson's disease moderate-to-severe idiopathic restless legs syndrome. The pharmacokinetics pharmacodynamics drug may vary between subjects different ethnic origin. This study...
This study was undertaken to evaluate the long-term safety, tolerability, and efficacy of adjunctive brivaracetam (BRV) treatment in pediatric patients with epilepsy.A phase 3, open-label, multicenter, follow-up trial (N01266; NCT01364597) conducted on (aged 1 month <17 years at core entry; direct enrollers aged 4 years) treated BRV. Outcomes included treatment-emergent adverse events (TEAEs), behavior assessments (Achenbach Child Behavior Checklist [CBCL], Rating Inventory Executive...
Although the analytical literature seems abundant for determination of metoprolol in human plasma, a method using standard equipment providing sensitive and simple high-performance liquid chromatographic (HPLC) limited blood volume, e.g. where 1 mL kg infant equals 70 adult has rarely been addressed. Therefore, 500 microL was extracted an internal solid-phase extraction columns. Chromatographic analysis performed on Spherisorb C(6) column (5 microm particle size) at ambient temperature...
To evaluate long-term safety and tolerability of adjunctive brivaracetam (BRV) in children with epilepsy.This was an interim analysis (cut-off March 15, 2017) pooled data from two open-label, single-arm, multicentre trials. N01263 (NCT00422422) a 3-week trial BRV 0.8-4 mg/kg/day patients (1 month-<16 years) epilepsy. Patients who completed this could continue into follow-up (N01266, NCT01364597) which also directly enrolled (4-<17 focal seizures. After dose-escalation, received 1-5 (maximum...
To evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) in neonates with repeated electroencephalographic seizures not controlled previous antiseizure medications (ASMs). Phase 2/3, multicenter, open-label, single-arm study (N01349/NCT03325439) (lasting ≥10 s) confirmed by video-electroencephalography, inadequate seizure control at least one ASM. A screening period (up to 36 h) was followed a 48-h evaluation during which patients received 0.5 mg/kg BRV twice...
Rotigotine transdermal patch is approved for the treatment of early and advanced idiopathic Parkinson's disease (PD) moderate-to-severe restless legs syndrome (RLS). A cold chain manufacturing distribution process was temporarily implemented in 2008, as this reduced crystal formation reported within patches stored at room temperature. In order to overcome crystallization issue meet EMA FDA requirements, a new temperature stable formulation developed. The three studies here were conducted...
<i>Aim: </i>The aim of this study was to evaluate the pharmacokinetics (PK) single and repeated doses lacosamide in healthy male Korean volunteers compare PK profile Caucasian populations. <i>Methods:</i> In a double-blind, placebo-controlled, parallel-group, dose-escalation trial, 16 received dose (50 mg) or placebo, 32 were administered single/repeated twice-daily (100 200 placebo. <i>Results:</i> For multiple 100 mg twice daily, geometric means...
Rotigotine, a non-ergolinic dopamine receptor agonist administered transdermally via patch, is metabolized by several cytochrome P-450 (CYP450) isoenzymes, including CYP2C19. This open-label, multiple-dose study evaluated the effect of omeprazole, competitive inhibitor CYP2C19, on pharmacokinetics rotigotine and its metabolites under steady-state conditions in healthy male subjects (of extensive metabolizer phenotype, CYP2C19). Subjects received 2 mg/24 hours days 1-3, 4 4-12, omeprazole 40...
Objective: In patch-based transdermal drug delivery, adhesiveness is critical for safe and effective treatment, especially in Parkinson's disease (PD) where excessive sweating common. This study compared the of two patch formulations rotigotine (improved room temperature-stable [PR2.3.1/Treatment A] intermediate cold storage product [PR2.1.1/Treatment B]), using largest size (40 cm2).Methods: PD0018 (NCT02230904) was a multicenter, randomized, double-blind, crossover study. PD patients...
To assess the influence of transdermally applied dopamine agonist rotigotine on ovulation suppression by a combined oral contraceptive (0.03 mg ethinyloestradiol and 0.15 levonorgestrel) in randomized, double-blind crossover study 40 healthy females.Treatment A consisted for 28 days plus first 13 (2 (24 h)(-1) 1-3, 3 maintenance dose thereafter). During treatment B, subjects received matching placebo patches instead rotigotine. Pharmacodynamic parameters (progesterone, oestradiol,...
An adult population pharmacokinetic/pharmacodynamic (PK/PD) model for the antiseizure medication (ASM) brivaracetam (BRV) was previously extended to children aged 4-16 years by using a pediatric BRV PK model. Effects were scaled information from combined adult-pediatric PK/PD of related ASM, levetiracetam (LEV).
Evaluate pharmacokinetics (PK)/tolerability of single-dose Staccato® alprazolam 2mg in adolescents with epilepsy.
Abstract Objective The objective of this study is to evaluate possible long‐term effects treatment with brivaracetam (BRV) on body weight in children epilepsy. Method Post hoc analysis data from patients (aged 1 month <17 years) ≥6 months BRV a long‐term, open‐label trial (N01266 [NCT01364597]). Outcomes included and mass index (BMI) over time ( z ‐score growth curves), treatment‐emergent adverse events (TEAEs). Previous/ongoing medical conditions that may affect (gastrointestinal...
Abstract Objective Despite introduction of several antiseizure medications over the past two decades, treatment options for childhood absence epilepsy (CAE) and juvenile (JAE) remain limited. We report innovative adaptive design an ongoing phase 2/3 trial to evaluate efficacy, safety, tolerability brivaracetam (BRV) monotherapy in patients 2–25 years age with CAE or JAE. Methods N01269 ( ClinicalTrials.gov : NCT04666610; start: July 2021; expected completion: 2024) is a randomized,...
<h3>Objective:</h3> Evaluate cognitive and behavioral effects of long-term adjunctive brivaracetam (BRV) in children with focal seizures. <h3>Background:</h3> Children epilepsy are at increased risk for problems. <h3>Design/Methods:</h3> Post-hoc analysis phase 3, open-label, follow-up trial (N01266; NCT01364597; patients <16 years core entry; ≤5 mg/kg/day BRV tablet/oral solution [≤200 mg/day]). Planned duration ≥3 years. Outcomes included Achenbach Child Behavior Checklist (CBCL; ages...