Advertisement

Topics

Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

2014-07-23 21:29:57 | BioPortfolio

Summary

This study is an open-label extension of Study E2080-A001-301. All patients will initiate the study at the total daily doses they were receiving at the end of the transition phase in E2080-A001-301 (2400 or 3200 mg/day) with an option, at the discretion of the Investigator, to incrementally increase doses to a maximum of 4800 mg/day. Safety variables and seizure frequency will be monitored throughout the study.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Refractory Partial Onset Seizures

Intervention

Rufinamide

Location

University of South Alabama Medical Center
Mobile
Alabama
United States
36693

Status

Active, not recruiting

Source

Eisai Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:29:57-0400

Clinical Trials [1292 Associated Clinical Trials listed on BioPortfolio]

Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

The primary objective of this study is to evaluate the effect of rufinamide on total partial seizure frequency in adolescent and adult patients with refractory partial onset seizures curre...

A Study of the Pharmacokinetics, Safety and Tolerability of Topiramate in Infants (Age 1-24 Months) With Refractory Partial-onset Seizures

The purpose of this study is to evaluate the pharmacokinetics safety and tolerability of topiramate in infants aged 1-24 months with refractory partial-onset seizures. Topiramate is an ant...

Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Patients With Partial Onset Seizures (Including Secondarily Generalized Seizures)

This study is conducted to evaluate the seizure-free rate of the 26-week Maintenance Period in untreated participants with partial onset seizures (POS).

Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures

Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial onset s...

A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures

This study will evaluate the effectiveness and safety of seletracetam when it is used in addition to other anti-epileptic medications by patients with partial onset seizures. It will also ...

PubMed Articles [5769 Associated PubMed Articles listed on BioPortfolio]

Tolerability of adjunctive eslicarbazepine acetate according to concomitant lamotrigine or carbamazepine use: A subgroup analysis of three phase III trials in adults with focal (partial-onset) seizures.

To evaluate and compare the effects of concomitant lamotrigine (LTG) or carbamazepine (CBZ) on the incidence of treatment-emergent adverse events (TEAEs) in patients taking adjunctive eslicarbazepine ...

Long-term tolerability, safety and efficacy of adjunctive perampanel in the open-label, dose-ascending Study 231 and extension Study 233 in Japanese patients with epilepsy.

To evaluate long-term tolerability, safety and efficacy of adjunctive perampanel in a Phase II, multicentre, open-label, dose-ascending Study 231 (NCT00849212) and its extension (Study 233; NCT0090378...

Low-Voltage Fast Seizures in Humans Begin With Increased Interneuron Firing.

Intracellular recordings from cells in entorhinal cortex tissue slices show that low voltage fast (LVF) onset seizures are generated by inhibitory events. Here, we determined whether increased firing ...

Automated detection of mesial temporal and temporoperisylvian seizures in the anterior thalamic nucleus.

Focal seizures can arise from coordinated activity across large-scale epileptic networks and propagate to regions that are not functionally altered but are recruited by epileptiform discharges. In pre...

A Comparison of Vagal Nerve Stimulation and Responsive Neurostimulation for the Treatment of Medically Refractory Complex Partial Epilepsy.

Neuromodulatory applications such as vagus nerve stimulation (VNS) and responsive neurostimulation (RNS) are safe and effective strategies for medically intractable epilepsy secondary to complex parti...

Medical and Biotech [MESH] Definitions

A disorder characterized by recurrent focal onset seizures which have sensory (i.e., olfactory, visual, tactile, gustatory, or auditory) manifestations. Partial seizures that feature alterations of consciousness are referred to as complex partial seizures (EPILEPSY, COMPLEX PARTIAL).

A syndrome characterized by the onset of isolated language dysfunction in otherwise normal children (age of onset 4-7 years) and epileptiform discharges on ELECTROENCEPHALOGRAPHY. Seizures, including atypical absence (EPILEPSY, ABSENCE), complex partial (EPILEPSY, COMPLEX PARTIAL), and other types may occur. The electroencephalographic abnormalities and seizures tend to resolve by puberty. The language disorder may also resolve although some individuals are left with severe language dysfunction, including APHASIA and auditory AGNOSIA. (From Menkes, Textbook of Child Neurology, 5th ed, pp749-50; J Child Neurol 1997 Nov;12(8):489-495)

Conditions characterized by recurrent paroxysmal neuronal discharges which arise from a focal region of the brain. Partial seizures are divided into simple and complex, depending on whether consciousness is unaltered (simple partial seizure) or disturbed (complex partial seizure). Both types may feature a wide variety of motor, sensory, and autonomic symptoms. Partial seizures may be classified by associated clinical features or anatomic location of the seizure focus. A secondary generalized seizure refers to a partial seizure that spreads to involve the brain diffusely. (From Adams et al., Principles of Neurology, 6th ed, pp317)

Seizures that occur during a febrile episode. It is a common condition, affecting 2-5% of children aged 3 months to five years. An autosomal dominant pattern of inheritance has been identified in some families. The majority are simple febrile seizures (generally defined as generalized onset, single seizures with a duration of less than 30 minutes). Complex febrile seizures are characterized by focal onset, duration greater than 30 minutes, and/or more than one seizure in a 24 hour period. The likelihood of developing epilepsy (i.e., a nonfebrile seizure disorder) following simple febrile seizures is low. Complex febrile seizures are associated with a moderately increased incidence of epilepsy. (From Menkes, Textbook of Child Neurology, 5th ed, p784)

An anticonvulsant used for several types of seizures, including myotonic or atonic seizures, photosensitive epilepsy, and absence seizures, although tolerance may develop. It is seldom effective in generalized tonic-clonic or partial seizures. The mechanism of action appears to involve the enhancement of GAMMA-AMINOBUTYRIC ACID receptor responses.

More From BioPortfolio on "Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures"

Advertisement
Quick Search
Advertisement
Advertisement

 

Searches Linking to this Trial