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Levetiracetam

Levetiracetam, also known by the brand name Keppra, is an antiepileptic medication that has been the subject of several clinical trials to assess its effectiveness and safety in treating epilepsy. These studies have examined various formulations of levetiracetam, including oral tablets, extended-release versions, and intravenous infusions, across different age groups and types of seizures. The trials aim to provide valuable insights into the drug’s pharmacokinetics, bioequivalence, and long-term effects in managing epilepsy symptoms.

Table of Contents

What is Levetiracetam?

Levetiracetam is an antiepileptic drug (AED) used to treat various types of seizures. It is also known by its brand name Keppra[1]. Levetiracetam is available in different forms, including oral tablets, oral solution, and intravenous (IV) infusion[2]. This medication has been studied extensively in both adults and children with epilepsy.

What Conditions Does Levetiracetam Treat?

Levetiracetam is primarily used to treat the following conditions:

  • Partial onset seizures: These are seizures that start in one specific area of the brain[3].
  • Generalized tonic-clonic seizures: These seizures affect the entire brain and cause loss of consciousness and muscle contractions[4].
  • Epilepsy: A neurological disorder characterized by recurrent seizures[5].

In some cases, Levetiracetam has also been studied for use in treating seizures associated with cerebral malaria, a severe complication of malaria infection that affects the brain[6].

How Does Levetiracetam Work?

While the exact mechanism of action is not fully understood, Levetiracetam is believed to work by binding to a specific protein in the brain called SV2A. This interaction helps to reduce abnormal electrical activity in the brain that causes seizures[7].

How is Levetiracetam Administered?

Levetiracetam can be administered in several ways:

  • Oral tablets: These are taken by mouth, usually twice daily[3].
  • Oral solution: This liquid form is useful for patients who have difficulty swallowing tablets[3].
  • Extended-release tablets (Keppra XR): These are taken once daily and provide a steady release of the medication over time[5].
  • Intravenous (IV) infusion: This method is used in hospital settings when oral administration is not possible[2].

The dosage of Levetiracetam varies depending on the patient’s age, weight, and specific condition. It’s important to take the medication exactly as prescribed by your doctor.

Efficacy of Levetiracetam

Clinical trials have shown that Levetiracetam is effective in reducing seizure frequency in both adults and children with epilepsy. Some key findings include:

  • A significant reduction in partial onset seizure frequency compared to placebo[3].
  • Effectiveness as monotherapy (used alone) in newly diagnosed epilepsy patients[4].
  • Long-term efficacy and safety in children with epilepsy[3].

One study found that about 50% of patients experienced a reduction in seizure frequency of at least 50% when taking Levetiracetam[3].

Safety and Side Effects

Levetiracetam is generally well-tolerated, but like all medications, it can cause side effects. Common side effects may include:

  • Drowsiness or fatigue
  • Dizziness
  • Weakness
  • Headache
  • Nausea
  • Irritability or behavioral changes (especially in children)

Serious side effects are rare but may include severe mood changes, thoughts of self-harm, or allergic reactions. It’s important to report any unusual symptoms to your healthcare provider[8].

Use in Special Populations

Levetiracetam has been studied in various patient groups:

  • Children: It has shown efficacy and safety in pediatric patients with epilepsy, including infants as young as 1 month old[3].
  • Elderly: Dose adjustments may be necessary in older adults, especially those with reduced kidney function[9].
  • Pregnant women: While data is limited, Levetiracetam is considered to have a relatively low risk during pregnancy compared to some other antiepileptic drugs. However, the potential risks and benefits should be discussed with a healthcare provider[7].

Ongoing Research

Research on Levetiracetam continues to explore its potential uses and optimize its administration. Some areas of ongoing study include:

  • Use in treating seizures associated with cerebral malaria in children[6].
  • Comparison of extended-release formulations (Keppra XR) with standard formulations[5].
  • Long-term safety and efficacy studies in various patient populations[8].

These ongoing studies aim to further improve our understanding of Levetiracetam and its potential benefits for patients with epilepsy and other seizure disorders.

Aspect Details
Drug Formulations Oral tablets, Extended-release (XR) tablets, Intravenous (IV) infusion
Age Groups Studied Children (4-16 years), Adults (18-55 years)
Primary Conditions Epilepsy, Partial onset seizures
Treatment Approaches Monotherapy, Adjunctive therapy
Key Outcomes Measured Seizure frequency reduction, Seizure-free days, Pharmacokinetics, Safety and tolerability
Study Durations Short-term (days to weeks), Long-term (months to years)
Dosage Ranges 1000-3000 mg/day for adults, Weight-based dosing for children
Safety Assessments Adverse events, Global Evaluation Scale ratings
Pharmacokinetic Parameters Cmax, AUC, Tmax, Half-life, Clearance, Volume of distribution
Bioequivalence Studies Comparing oral vs. IV formulations, Different manufacturers’ formulations

FAQ

  • What is the primary use of Levetiracetam in clinical trials? Levetiracetam is primarily used in clinical trials to treat epilepsy, particularly for partial onset seizures. It is studied as both an adjunctive therapy (added to other medications) and as monotherapy (used alone) for managing seizures in patients with epilepsy.
  • Are there different formulations of Levetiracetam being studied? Yes, clinical trials have investigated various formulations of Levetiracetam, including oral tablets, extended-release (XR) versions, and intravenous (IV) infusions. These different forms are studied to determine their effectiveness, safety, and how the body processes them.
  • What age groups are included in Levetiracetam clinical trials? Levetiracetam clinical trials have included a wide range of age groups. Some studies focus on children (from 4 to 16 years old), while others involve adults (typically 18 to 55 years old). There are also trials specifically designed to compare the drug's effects in children and adults.
  • What are some common outcomes measured in Levetiracetam trials? Common outcomes measured in Levetiracetam trials include the reduction in seizure frequency, the percentage of patients achieving at least a 50% reduction in seizures, the number of seizure-free days, and changes in seizure severity. Additionally, safety outcomes such as adverse events and tolerability are closely monitored.
  • How long do Levetiracetam clinical trials typically last? The duration of Levetiracetam clinical trials can vary widely. Some short-term studies may last only a few days or weeks, particularly those focusing on pharmacokinetics or bioequivalence. Long-term follow-up studies can extend for several months to years, with some lasting up to 2-3 years to assess the drug's long-term efficacy and safety.

Ongoing Clinical Trials on Levetiracetam

  • Study of levetiracetam to prevent seizures in adults who have both Down syndrome and Alzheimer’s disease

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of anti-seizure drug combination in comatose patients with status epilepticus after cardiac arrest

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium The Netherlands

  • Study on the Effectiveness and Safety of Levetiracetam XR for Patients with Drug-Resistant Partial Onset Epilepsy

    Recruiting

    3 1 1
    Investigated drugs:
    Bulgaria Czechia Germany Greece Hungary Italy +3

  • Study on Anti-CD19 CAR T-Cell Therapy for Patients with Refractory Systemic Autoimmune Diseases Using Levetiracetam, Fludarabine, and a Drug Combination

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on Fast Sedation with Propofol and Midazolam vs. Anti-Seizure Drug Combination for Treating Refractory Status Epilepticus in Intensive Care Patients

    Recruiting

    3 1 1 1
    Investigated drugs:
    Denmark

  • A Study of Levetiracetam for Prevention and Treatment of Delirium in Adult ICU Patients with Septic Shock

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Safety and Dosage of GD2IL18CART for Patients with Relapsed or Refractory GD2 Positive Solid Cancers

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Treating Status Epilepticus in Seniors Using Levetiracetam and Valproate Semisodium

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study evaluating the effect of levetiracetam on recovery in patients with intracerebral haemorrhage

    Not yet recruiting

    3 1 1
    Investigated drugs:
    France

  • A study to evaluate the safety and effectiveness of subcutaneous blinatumomab in adults and adolescents with relapsed, refractory, or minimal residual disease positive B-cell precursor acute lymphoblastic leukemia.

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Romania +1

Glossary

  • Levetiracetam: An antiepileptic medication used to treat various types of seizures. It is also known by the brand name Keppra.
  • Epilepsy: A neurological disorder characterized by recurrent seizures, which are sudden, uncontrolled electrical disturbances in the brain.
  • Partial onset seizures: Seizures that start in one area of the brain, also known as focal seizures. They can sometimes spread to other parts of the brain.
  • Adjunctive therapy: The use of a medication in addition to the primary treatment to enhance its effectiveness. In epilepsy, it refers to adding a new antiepileptic drug to existing medications.
  • Monotherapy: The use of a single medication to treat a condition. In epilepsy trials, it refers to using Levetiracetam as the sole antiepileptic drug.
  • Pharmacokinetics: The study of how the body processes a drug, including its absorption, distribution, metabolism, and elimination.
  • 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.
  • Extended-release (XR): A formulation of a drug designed to release the active ingredient slowly over time, allowing for less frequent dosing.
  • Intravenous (IV) infusion: The administration of a drug directly into a vein using a needle or tube, allowing for rapid delivery into the bloodstream.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Tolerability: The degree to which overt adverse effects of a drug can be tolerated by a patient.
  • Efficacy: The ability of a drug to produce the desired therapeutic effect.
  • Titration: The process of gradually adjusting the dose of a medication to find the optimal balance between therapeutic effect and side effects.
  • Global Evaluation Scale (GES): A tool used to assess overall changes in a patient's condition, typically ranging from marked improvement to marked worsening.

References

  1. https://clinicaltrials.gov/study/NCT00961441
  2. https://clinicaltrials.gov/study/NCT01618903
  3. https://clinicaltrials.gov/study/NCT00150709
  4. https://clinicaltrials.gov/study/NCT00150735
  5. https://clinicaltrials.gov/study/NCT00419094
  6. https://clinicaltrials.gov/study/NCT01660672
  7. https://clinicaltrials.gov/study/NCT00150787
  8. https://clinicaltrials.gov/study/NCT00419393
  9. https://clinicaltrials.gov/study/NCT00291655