More Information
Neurology News
Neurology Clinical Trials
Ways to Give
Web Rounds

 

Neurology

Strong Epilepsy Center

Research and Clinical Trials

Current Clinical Trials

Strong Epilepsy Center is committed to providing the highest standard of care for our patients. As part of this mission, we participate in trials of new medications before their release to the public. These drug studies, usually sponsored by the pharmaceutical company that is developing the drug, allow patients to have access to drugs that may not otherwise be available for years. The goal is to determine whether the new drug is effective (does it control seizures?) and safe (that is, does it have troublesome side effects?).

How do New Medicines Come to be Used?

  • New medicines are developed at pharmaceutical companies.
  • They are developed based on known or suspected actions.

  • They are screened in animal models of seizures to be sure they are effective.

    Phase I clinical trials determine whether drug is safe in human volunteers (small sample populations).

    Phase II clinical trials determine efficacy and safety in humans over relatively short time frames.

    Phase III clinical trials determine safety and efficacy in large populations, usually over longer time frames.

If a drug is safe and effective, it is released to the public, after which -

Phase IV trials test whether the new drug is effective under select circumstances (different seizure types, patient age groups, etc.)

How do Drug Trials Work?

Drug trials compare the new drug to other currently available drugs or to placebo, an inactive pill, or as an add-on to the patient’s usual drugs.

Patients are randomly assigned to receive either the experimental agent or an inactive substitute; neither the patient nor the doctor knows which (randomized, ‘double-blind’).. Some drug trials are designed so that participants may receive both a placebo and the new drug at different times.

There are pros and cons to participation:

Pro: Medical care is usually very comprehensive (and usually free).

Pro: Access to new drugs that are not otherwise available.

Con: Uncertain drug effectiveness, unknown side effects or toxicity.

The Epilepsy Center participates in phase II-IV trials. Currently under way are studies for the following seizures types:

  • Mesial Temporal Lobe Epilepsy-Early Randomized Surgical Epilepsy Trial (ERSET)
  • Primary Generalized Epilepsy (Keppra)
  • Partial Seizures (Lamictal)