Open-label Follow up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Aged 16 Years or Older Suffering From Epilepsy.
Summary
This trial, evaluating the long-term safety and tolerability of brivaracetam will provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment.
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Epilepsy
Intervention
Brivaracetam
Location
1051
Phoenix
Arizona
United States
Status
Active, not recruiting
Source
UCB, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00150800
- Information obtained from ClinicalTrials.gov on March 26, 2013
Medical and Biotech [MESH] Definitions
Myoclonic Epilepsy, Juvenile
A disorder characterized by the onset of myoclonus in adolescence, a marked increase in the incidence of absence seizures (see EPILEPSY, ABSENCE), and generalized major motor seizures (see EPILEPSY, TONIC-CLONIC). The myoclonic episodes tend to occur shortly after awakening. Seizures tend to be aggravated by sleep deprivation and alcohol consumption. Hereditary and sporadic forms have been identified. (From Adams et al., Principles of Neurology, 6th ed, p323)
Epilepsy
A disorder characterized by recurrent episodes of paroxysmal brain dysfunction due to a sudden, disorderly, and excessive neuronal discharge. Epilepsy classification systems are generally based upon: (1) clinical features of the seizure episodes (e.g., motor seizure), (2) etiology (e.g., post-traumatic), (3) anatomic site of seizure origin (e.g., frontal lobe seizure), (4) tendency to spread to other structures in the brain, and (5) temporal patterns (e.g., nocturnal epilepsy). (From Adams et al., Principles of Neurology, 6th ed, p313)
Mephenytoin
An anticonvulsant effective in tonic-clonic epilepsy (EPILEPSY, TONIC-CLONIC). It may cause blood dyscrasias.
Epilepsy, Rolandic
An autosomal dominant inherited partial epilepsy syndrome with onset between age 3 and 13 years. Seizures are characterized by PARESTHESIA and tonic or clonic activity of the lower face associated with drooling and dysarthria. In most cases, affected children are neurologically and developmentally normal. (From Epilepsia 1998 39;Suppl 4:S32-S41)
Epilepsy, Reflex
A subtype of epilepsy characterized by seizures that are consistently provoked by a certain specific stimulus. Auditory, visual, and somatosensory stimuli as well as the acts of writing, reading, eating, and decision making are examples of events or activities that may induce seizure activity in affected individuals. (From Neurol Clin 1994 Feb;12(1):57-8)
Clinical Trials
This will be the first study with brivaracetam in children suffering from epilepsy, preceding further evaluation of its efficacy and tolerability.
New treatments should be made available to epileptic patients. Studies using brivaracetam in adults with epilepsy have shown promising results. This study will confirm the efficacy and saf...
New treatments should be made available to epileptic patients. Studies using brivaracetam in adults with epilepsy have shown promising results. This study will confirm the efficacy and saf...
This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50mg/day in b.i.d. administration) as add on therapy in subjects with focal epilepsy and help to nar...
A Study of Brivaracetam in Subjects With Partial Onset Seizures
This trial will evaluate the efficacy and safety of brivaracetam (at doses of 50 and 150 mg/day in b.i.d. administration) as add on therapy in subjects with focal epilepsy and help to narr...
PubMed Articles
Brivaracetam is a novel synaptic vesicle protein 2A (SV2A) ligand reported to be 10 fold more potent than levetiracetam in animal models of epilepsy. This study reports the binding profile of brivarac...
Brivaracetam for the treatment of epilepsy.
Introduction: Epilepsy is one of the most common neurological disorders, affecting about 1% of the population worldwide. With currently available antiepileptic drugs, one-third of patients continue to...
Brivaracetam does not alter spatial learning and memory in both normal and amygdala-kindled rats.
Several antiepileptic drugs (AEDs) may induce memory deficits when tested in preclinical models at doses that exert significant protection against seizures. Brivaracetam (BRV) is a novel high-affinity...
Epilepsy research: Occurrences of sudden death in dogs with epilepsy may be numbered.
Genetic evaluation and counseling for epilepsy.
The contribution of genetics to both rare and common epilepsies is rapidly being elucidated, and neurologists are routinely considering genetic testing in the work-up of several epilepsy syndromes of...
