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PRX-00023 Therapy in Localization-Related Epilepsy



Eligibility Criteria:

Inclusion:

  • Are between 18 and 65 years old.
  • Have tried to stop your seizures by taking at least two different standard anti-seizure medications (either at the same time or one after the other) that were prescribed and monitored by your local physician and you are still having seizures.
  • Have frequent seizures.
  • Are able to maintain your current anticonvulsant drugs and dosages while you are in the study.
  • Must be enrolled in protocol 01-N-0139.

Exclusion:

  • Have a known cause for your seizures such as tumor or infection.
  • Have a serious medical illness, other than epilepsy, requiring a medication that cannot safely be stopped or abnormal results on blood tests we will perform.
  • Have a brain abnormality such as a brain tumor, brain damage from head trauma or blood vessel abnormalities, on an MRI scan.
  • Are pregnant or breast feeding.  Women of childbearing potential must agree to use an effective form of birth control while on the study medication and for three months afterwards.  Men should use contraceptive techniques as well.
  • Have a high risk of suicide as determined by the Columbia Suicide Severity Rating Scale.
  • Have to take more than two anti-seizure medications. Sublingual lorazepam for a prolonged seizure or cluster is allowed and does not count as one of the two medications.
  • Have certain types of metal in your body that would make having an MRI scan unsafe.
  • Are taking, or have recently taken, medications that would make your participation unsafe or would interfere with the study results such as--phenytoin or phenobarbital.

Last updated July 18, 2014