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Perampanel

Perampanel, also known by its brand name Fycompa, is a medication being studied in clinical trials for the treatment of epilepsy and seizures. These trials aim to evaluate its effectiveness, safety, and optimal dosing when used alone or in combination with other anti-epileptic drugs. Researchers are investigating perampanel in various forms, including oral tablets, oral suspension, and intravenous infusions, to understand its potential benefits for patients with different types of seizures.

Table of Contents

What is Perampanel?

Perampanel is a medication used to treat certain types of seizures in people with epilepsy. It is also known by its brand name Fycompa[1] or by its research code E2007[2]. Perampanel is classified as an anti-epileptic drug (AED) and is typically used as an add-on treatment, which means it is given in addition to other seizure medications[1].

Medical Conditions Treated

Perampanel is used to treat the following types of seizures:

  • Partial-onset seizures (also called focal seizures): These are seizures that start in one part of the brain[2].
  • Secondarily generalized seizures: These are partial-onset seizures that spread to involve both sides of the brain[2].
  • Primary generalized tonic-clonic seizures (PGTC): These are seizures that involve the entire brain from the start[1].

Perampanel is approved for use in patients aged 12 years and older with these types of seizures[2].

How Perampanel Works

Perampanel works by targeting specific receptors in the brain called AMPA receptors. These receptors are involved in the transmission of electrical signals between brain cells. By blocking these receptors, Perampanel helps to reduce excessive electrical activity in the brain that can lead to seizures[3].

Forms and Administration

Perampanel comes in several forms:

  • Oral tablets[4]
  • Oral suspension (a liquid form)[1]
  • Intravenous (IV) infusion (in some clinical trials)[5]

The most common form is the oral tablet, which is typically taken once daily before bedtime. The dose is usually started low and gradually increased based on the patient’s response and tolerance to the medication[2].

Effectiveness

Several studies have shown that Perampanel can be effective in reducing seizure frequency in patients with epilepsy. Some key findings include:

  • Reduction in seizure frequency: Many patients experience a significant decrease in the number of seizures they have[6].
  • Seizure freedom: Some patients may become completely seizure-free while taking Perampanel[6].
  • Long-term effectiveness: Studies have shown that Perampanel can remain effective for extended periods, with some patients continuing to benefit from the medication for 12 months or longer[1].

Side Effects and Safety

Like all medications, Perampanel can cause side effects. Common side effects may include:

  • Dizziness
  • Sleepiness
  • Irritability
  • Falls
  • Problems with coordination

More serious side effects, though less common, can include changes in mood or behavior, such as aggression or suicidal thoughts[2]. It’s important to report any side effects to your healthcare provider.

Special Considerations

There are some special considerations to keep in mind when taking Perampanel:

  • Driving and operating machinery: Perampanel can cause drowsiness and dizziness, which may affect your ability to drive or operate machinery safely[3].
  • Alcohol: Drinking alcohol while taking Perampanel may increase side effects like dizziness and sleepiness[3].
  • Pregnancy and breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential risks and benefits of Perampanel with your doctor[2].
  • Other medications: Perampanel can interact with other medications, including some birth control pills. Always inform your doctor about all medications you are taking[3].

Remember, Perampanel is a prescription medication that should only be taken under the guidance of a healthcare professional. Never adjust your dose or stop taking the medication without consulting your doctor first.

Aspect Details
Drug Name Perampanel (Brand name: Fycompa)
Indications Studied Partial-onset seizures, Generalized tonic-clonic seizures, Idiopathic generalized epilepsy
Administration Forms Oral tablets, Oral suspension, Intravenous infusion
Dosage Range 2 mg to 12 mg daily
Primary Outcomes Retention rate, Seizure frequency reduction, Safety profile
Secondary Outcomes Seizure freedom rates, Quality of life measures, Pharmacokinetic parameters
Patient Populations Adults and adolescents (12 years and older) with epilepsy, Healthy volunteers for pharmacokinetic studies
Study Designs Randomized controlled trials, Open-label studies, Observational studies, Bioequivalence studies
Key Safety Assessments Adverse events monitoring, Laboratory tests, Vital signs, ECG

FAQ

  • What is perampanel and how does it work? Perampanel is an anti-epileptic medication that works by reducing excessive electrical activity in the brain. It is being studied for the treatment of partial-onset seizures and generalized tonic-clonic seizures in patients with epilepsy.
  • What types of seizures is perampanel being studied for? Clinical trials are investigating perampanel for partial-onset seizures (with or without secondary generalization) and primary generalized tonic-clonic seizures associated with idiopathic generalized epilepsy.
  • How is perampanel administered in clinical trials? Perampanel is being studied in various forms, including oral tablets, oral suspension, and intravenous infusions. The dosage and administration method may vary depending on the specific trial and patient needs.
  • What are some of the main outcomes being measured in perampanel clinical trials? Key outcomes include retention rate (percentage of patients continuing treatment), seizure frequency reduction, seizure freedom rates, and safety assessments such as adverse events and laboratory tests.
  • Are there any special considerations for patients participating in perampanel clinical trials? Participants in perampanel trials may need to undergo regular blood tests, physical examinations, and seizure frequency monitoring. Some trials may require patients to keep seizure diaries or follow specific dosing schedules.

Ongoing Clinical Trials on Perampanel

  • Study on the Effectiveness and Safety of Perampanel for Children with Epilepsy

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Spain

  • Study on Perampanel Treatment Before Surgery for Patients with Progressive Glioblastoma

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Perampanel for Improving Behavior and Quality of Life in Patients with White-Sutton Syndrome

    Not yet recruiting

    1 1 1
    Investigated drugs:
    Italy

  • A study to compare how the body absorbs perampanel in healthy adult men and women during fasting conditions

    Not recruiting

    1 1 1
    Investigated drugs:
    Czechia

  • A study to compare how perampanel is absorbed in healthy adult men and women.

    Not recruiting

    1 1 1
    Investigated drugs:
    Czechia

Glossary

  • Perampanel: An anti-epileptic medication being studied for the treatment of partial-onset seizures and generalized tonic-clonic seizures in patients with epilepsy.
  • Partial-onset seizures: Seizures that start in one area of the brain and may or may not spread to other areas.
  • Generalized tonic-clonic seizures: Seizures that affect both sides of the brain from the start and cause loss of consciousness and muscle stiffening followed by jerking movements.
  • Idiopathic generalized epilepsy: A type of epilepsy with no known cause that involves seizures affecting both sides of the brain from the start.
  • Retention rate: The percentage of patients who continue taking a medication over a specified period, often used as a measure of effectiveness and tolerability.
  • Bioequivalence: The property of two drug products having the same active ingredient to be pharmaceutically equivalent and to have the same effect in the body.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Adjunctive therapy: An additional treatment used together with the primary treatment to increase its effectiveness.
  • Treatment-emergent adverse event (TEAE): An adverse event that appears or worsens during the course of a clinical study.
  • Seizure freedom: A state in which a person with epilepsy experiences no seizures for a specified period.

References

  1. https://clinicaltrials.gov/study/NCT04202159
  2. https://clinicaltrials.gov/study/NCT04230044
  3. https://clinicaltrials.gov/study/NCT04257604
  4. https://clinicaltrials.gov/study/NCT03399734
  5. https://clinicaltrials.gov/study/NCT03754582
  6. https://clinicaltrials.gov/study/NCT04252846