CLINICAL TRIAL

Perampanel for Seizures

Recruiting · 18+ · All Sexes · Roanoke, VA

This study is evaluating whether perampanel crosses the blood brain barrier.

See full description

About the trial for Seizures

Eligible Conditions
Seizures · Epilepsy

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.

Experimental Group 1
Perampanel
DRUG
Experimental Group 2
Perampanel
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Perampanel
FDA approved

Side Effect Profile for Perampanel + Current Anti-Epileptic Drug

Perampanel + Current Anti-Epileptic Drug
Show all side effects
75%
Fatigue
38%
Hyperglycemia
38%
Platelet count decreased
25%
Nausea
25%
Creatinine increased
25%
Dizziness
25%
Hypokalemia
25%
Confusion
25%
Nervous system disorders - Other, specify
25%
Pyramidal tract syndrome
25%
Mucosal infection
13%
Hemorrhoids
13%
Diarrhea
13%
Hypermagnesemia
13%
Multi-organ failure
13%
Dysphagia
13%
Alanine aminotransferase increased
13%
Anmia
13%
Rash acneiform
13%
Anemia
13%
Hyperkalemia
13%
Hyponatremia
13%
Musculoskeletal and connective tissue disorder - Other, specify
13%
Renal and urinary disorders - Other, specify
13%
Ear and labyrinth disorders - Other, specify
13%
Lung infection
13%
Fall
13%
Constipation
13%
Eye disorders - Other, specify
13%
Gastrointestinal disorders - Other, specify
13%
Vomiting
13%
Urinary tract infection
13%
Sinusitis
13%
Upper respiratory infection
13%
Neutrophil count decreased
13%
Injury, poisoning and procedural complications - Other, specify
13%
Dehydration
13%
Hypocalcemia
13%
Thromboembolic event
13%
Insomnia
13%
Somnolence
13%
Hematuria
13%
Epistaxis
13%
Facial nerve disorder
13%
Anxiety
13%
Respiratory failure
13%
Hypoxia
13%
Dysphasia
13%
Seizure
13%
Proteinuria
13%
Memory impairment
13%
Headache
13%
Bronchopulmonary hemorrhage
13%
Myalgia
Fatigue
75%
Hyperglycemia
38%
Platelet count decreased
38%
Nausea
25%
Creatinine increased
25%
Dizziness
25%
Hypokalemia
25%
Confusion
25%
Nervous system disorders - Other, specify
25%
Pyramidal tract syndrome
25%
Mucosal infection
25%
Hemorrhoids
13%
Diarrhea
13%
Hypermagnesemia
13%
Multi-organ failure
13%
Dysphagia
13%
Alanine aminotransferase increased
13%
Anmia
13%
Rash acneiform
13%
Anemia
13%
Hyperkalemia
13%
Hyponatremia
13%
Musculoskeletal and connective tissue disorder - Other, specify
13%
Renal and urinary disorders - Other, specify
13%
Ear and labyrinth disorders - Other, specify
13%
Lung infection
13%
Fall
13%
Constipation
13%
Eye disorders - Other, specify
13%
Gastrointestinal disorders - Other, specify
13%
Vomiting
13%
Urinary tract infection
13%
Sinusitis
13%
Upper respiratory infection
13%
Neutrophil count decreased
13%
Injury, poisoning and procedural complications - Other, specify
13%
Dehydration
13%
Hypocalcemia
13%
Thromboembolic event
13%
Insomnia
13%
Somnolence
13%
Hematuria
13%
Epistaxis
13%
Facial nerve disorder
13%
Anxiety
13%
Respiratory failure
13%
Hypoxia
13%
Dysphasia
13%
Seizure
13%
Proteinuria
13%
Memory impairment
13%
Headache
13%
Bronchopulmonary hemorrhage
13%
Myalgia
13%
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT02363933) in the Perampanel + Current Anti-Epileptic Drug ARM group. Side effects include: Fatigue with 75%, Hyperglycemia with 38%, Platelet count decreased with 38%, Nausea with 25%, Creatinine increased with 25%.

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Someone who is able to provide informed consent is someone who is capable of making a decision that is well-informed show original
before and after surgery should continue taking their usual medication regimen throughout the perioperative period show original
View All
Odds of Eligibility
High>50%
You meet most of the criteria! It's probably a good idea to apply to 1 other trial just in case this doesn't work out.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 3 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

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.

Blood brain barrier serum levels
3 WEEKS
To determine the blood brain barrier(BBB) penetration of PER by measuring ratio of serum level to that of CSF measured on simultaneously obtained samples
3 WEEKS

Who is running the study

Principal Investigator
A. S.
Aashit Shah, Chief of Neurology
Carilion Clinic

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer

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.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Seizures by sharing your contact details with the study coordinator.