Perampanel for Seizures
This study is evaluating whether perampanel crosses the blood brain barrier.
See full descriptionAbout the trial for Seizures
Treatment Groups
This trial involves 2 different treatments. Perampanel is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.
About The Treatment
Side Effect Profile for Perampanel + Current Anti-Epileptic Drug
Eligibility
This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Perampanel will improve 1 primary outcome in patients with Seizures. Measurement will happen over the course of 3 weeks.
Who is running the study
Principal InvestigatorPatient Q & A Section
Can seizures be cured?
[Without medication], up to 75% of patients with [severe and refractory epilepsies] suffer from seizures. [Long-term therapy with anti-epileptic drugs has proven to be effective in cases of severe epilepsies and refractory epilepsy (both tonic-clonic and myoclonic-astatic forms).] [Tetanus/DTP immunity can be acquired before vaccination is started and administered annually. The incidence of postnatal complications is reduced and death is almost eliminated.] Epilepsy can usually be cured by anti-seizure drugs. In this report, we describe the treatment of a single patient suffering from severe childhood epilepsy, which had persisted for more than 12 years.
What are common treatments for seizures?
Seizure control is often achieved through anticonvulsant medication. When an anticonvulsant drug is ineffective in controlling a person's seizures, an antiepileptic drug which has a different mechanism of action may be used.
What is seizures?
Seizures can be disabling, and cause a range of negative effects on a family’s life and employability. About one fifth of all new cases of epilepsy develop during childhood. Most seizures are not due to accidents, strokes or complications in childbirth. Seizures occur in nearly every country and every major language group. Seizures are not unheard of: 1 in 8 is thought to have had one at some point in his life.\n\nWhy the brain?\nThe brain has a unique shape and function. It is in charge of storing our memories and processing information that comes in so we may respond to the outside world and keep us alive.\nThere is enormous genetic variation in the brain.
What causes seizures?
The causes of seizures are multifactorial, and not every single one can be identified. The role of genetics, the environment, and the physiology of the brain are interdependent. The most common causes are idiopathic and acquired post-traumatic seizures.
What are the signs of seizures?
Seizures occur most frequently in childhood, with sudden onset being the most typical presenting symptom of an underlying cause such as a lesion. There is often a family history of epilepsy, and there are some specific characteristics of seizures. Seizures can be of several types; however, each seizure usually starts as a'simple' partial seizure, before progressing, particularly in children, to a 'complex' partial seizure and ultimately a generalized tonic-clonic seizure, with other signs such as loss of vision, unconsciousness and coma. These last two are very serious and have a bad prognosis, especially if they lead to death. Children with seizures are also more likely to have epilepsy than adults.
How many people get seizures a year in the United States?
Approximately 9 million people per year in the U.S. are diagnosed with epilepsy. This makes up 27.8% of American adults. Many of these people who are diagnosed have drug-resistant epilepsy, and epilepsy can be a risk factor for suicide.
Does seizures run in families?
Families with idiopathic or symptomatic epilepsy have a higher rate of seizure recurrence. Further investigation of epilepsy genetics seems warranted to identify genes or alleles that confer an increased risk for epilepsy.
What is the primary cause of seizures?
Only about 25% of persons with epilepsy have a single epilepsy diagnosis. The most common predisposing causes of epilepsy are developmental delay, febrile seizures, or trauma. Epilepsy may also be associated with autism spectrum disorders. Most patients with epilepsy are not treated and are simply diagnosed as being epilepsy rather than as having another form of epilepsy.
Have there been any new discoveries for treating seizures?
Currently, no drugs have been approved by the FDA for anti-epileptic use, and several new antiepileptic medications are being trialed. Newer drugs are safer and more effective than older ones. These newer drugs include new class of antiepileptic drugs, such as the CB1 receptors agonists (RGS ligands). The GABA A receptor agonist tiagabine may have a potential therapeutic role in focal partial onset seizures. The GABA agonist gaboxadol is also under study. These antiepileptic medications can be used in patients who have not benefit from previous antiepileptic medications, as well as those with drug toxicity problems.
What is perampanel?
perampanel and the placebo comparator had similar safety profiles in this study with no significant increase in rate of hypersensitivity reactions between groups. Further studies are required to evaluate the efficacy and tolerability of perampanel in large, multicenter trials.
Is perampanel typically used in combination with any other treatments?
Almost 1 in 5 perampanel-treated patients had received prior AED, and these patients had a lower seizure-free survival compared with those who did not have AED and perampanel simultaneously.
What are the common side effects of perampanel?
Serious complications were experienced in a minority of patients. The most common side effects were constipation, insomnia, extrapyramidal side effects, and injection site reactions. The most common side effects were headache, dizziness, urinary incontinence, and abdominal pain. In this pilot study there was an increase in the overall incidence of peripheral neuropathy, including painful radiculopathy and neuropathic pain. Results from a recent clinical trial of this pilot study demonstrate the necessity of assessing the safety of the chosen perampanel dosage and the need to consider discontinuation criteria before beginning therapy.