A5079157384- Epilepsy research and treatment
- Pharmacological Effects and Toxicity Studies
- Neuroscience and Neuropharmacology Research
- Pharmaceutical studies and practices
- Pain Mechanisms and Treatments
- Cancer Treatment and Pharmacology
- Drug-Induced Adverse Reactions
- Ion channel regulation and function
- Psychosomatic Disorders and Their Treatments
- Botulinum Toxin and Related Neurological Disorders
- Respiratory and Cough-Related Research
- Chemotherapy-related skin toxicity
- Healthcare Decision-Making and Restraints
- Drug Transport and Resistance Mechanisms
- Families in Therapy and Culture
- Antibiotics Pharmacokinetics and Efficacy
- Trigeminal Neuralgia and Treatments
- Multiple Myeloma Research and Treatments
- Schizophrenia research and treatment
University of Minnesota Medical Center
1984
Patients with advanced cancer, previously untreated, were given 60 mg/m<sup>2</sup> cisplatin plus adriamycin by monthly intravenous injections. Signs and symptoms of a predominantly sensory peripheral neuropathy developed in 92% the patients. complained dysesthesias paresthesias hands feet. Clinically, there was progressive decrease or loss tendon reflexes, decreased vibratory sense, mild light touch pin sensation. Distal latencies became prolonged dropped out completely, but little change...
Summary Objective To evaluate the efficacy and safety of adjunctive eslicarbazepine acetate ( ESL ) in patients with refractory partial‐onset seizures. Methods This randomized, placebo‐controlled, double‐blind, parallel‐group, phase III study was conducted at 173 centers 19 countries, including United States Canada. Eligible were aged ≥16 years had uncontrolled seizures despite treatment 1–2 antiepileptic drugs AED s). After an 8‐week baseline period, randomized to once‐daily placebo (n =...
Importance Many patients with focal epilepsy experience seizures despite treatment currently available antiseizure medications (ASMs) and may benefit from novel therapeutics. Objective To evaluate the efficacy safety of XEN1101, a small-molecule selective Kv7.2/Kv7.3 potassium channel opener, in focal-onset (FOSs). Design, Setting, Participants This phase 2b, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging adjunctive trial investigated XEN1101 over an 8-week period...
To assess the safety and efficacy of once-daily (QD) adjunctive eslicarbazepine acetate (ESL).This post-hoc pooled analysis three randomized, placebo-controlled trials (2093-301, -302, -304) involved adults with refractory partial-onset seizures (POS) receiving 1-3 antiepileptic drugs (AEDs). All studies included 8-week baseline, 2-week titration, 12-week maintenance periods. Patients were randomized equally to placebo, ESL 400mg (studies 301, 302), 800mg, or 1200mg QD. The primary endpoint...
Summary Purpose A diazepam auto‐injector ( AI ) has been developed for intramuscular administration to treat acute repetitive seizures ARS ). The objective of this study was evaluate the efficacy and safety when administered by caregivers control an episode ClinicalTrials.gov identifier NCT00319501). Methods In phase III , randomized, double‐blind, parallel‐group, placebo‐controlled, multicenter study, subjects with epilepsy on a stable antiepileptic drug regimen who required intermittent...
Summary Objective Part 1 of this phase III study was a randomized, double‐blind, parallel‐group, placebo‐controlled, multicenter caregiver administered diazepam auto‐injector ( AI ) in subjects with acute repetitive seizures ARS and demonstrated that well‐tolerated significantly more effective than placebo delaying the time to next seizure or rescue. 2 study, presented herein, an open‐label continuation assess long‐term safety effectiveness for treatment . Methods Of 234 randomized part 1,...
To evaluate the effects of eslicarbazepine acetate (ESL) on lipid metabolism and to determine whether reduced statin exposure during ESL therapy has clinical consequences.We conducted a post-hoc analysis pooled data for serum lipids (laboratory values) from three phase III, multicenter, randomized, double-blind, placebo-controlled trials adjunctive (400, 800, or 1200 mg once daily) in patients with treatment-refractory partial-onset seizures. Changes baseline levels were analyzed according...
To evaluate cutaneous allergic reactions in clinical trials of adjunctive eslicarbazepine acetate (ESL) for focal seizures.Data were analyzed from three phase III randomized, double-blind, placebo-controlled studies ESL adults (placebo, n = 426; ESL, 1021) and two (and open-label extensions [OLEs]) children aged 4-17 years 160; 202; OLE, 337).Adult studies: Rash (ESL 1.9%, placebo 0.9%) pruritus 1.2%, the most frequent rash-related treatment-emergent adverse events (TEAEs). Most TEAEs mild...
To investigate the safety and tolerability of eslicarbazepine acetate (ESL), a once-daily oral anti-seizure drug (ASD), in older younger adult patient populations.Two post-hoc pooled data analyses were performed: one from three Phase III studies patients with focal (partial-onset) seizures who taking 1-3 concomitant ASDs; other five II non-epilepsy populations not ASDs chronically and/or at clinically-effective dose. The frequencies treatment-emergent adverse events (TEAEs) calculated for...
OBJECTIVE: Investigate the incidence of allergic reaction treatment-emergent adverse events (TEAEs) in patients treated with eslicarbazepine acetate (ESL) as adjunctive therapy for partial-onset seizures (POS). BACKGROUND: ESL is a novel once-daily (QD) anticonvulsant, extensively converted after oral administration to eslicarbazepine, which blocks voltage-gated sodium- and calcium-channels. DESIGN/METHODS: Data were pooled from three Phase III studies (BIA-2093-301/-302/-304)....
Objective: To investigate the safety and tolerability of adjunctive ESL in elderly patients with POS. Background: Age-related changes, such as reduced drug clearance a lower threshold for developing side effects, impact on antiepileptic (AED) choice (French JA, Gazzola DM. Continuum [Minneap Minn] 2013;19:643-55). It is therefore important to AEDs populations. Methods: Exploratory post-hoc analysis pooled data from three double-blind Phase III studies (BIA-2093-301, -302 -304) (≥60...