Early Surgical Intervention to Treat Epilepsy (NCT00040326) | Clinical Trial Compass
CompletedPhase 3
Early Surgical Intervention to Treat Epilepsy
United States200 participantsStarted 2002-07
Plain-language summary
The purpose of this trial is to compare the effectiveness of early surgical intervention for mesial temporal lobe epilepsy to continued treatment with antiepileptic drugs.
Who can participate
Age range12 Years
SexALL
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Inclusion criteria:
* Intractability: Two AEDs, one of which was either Dilantin, Tegretol, Carbatrol, or Trileptal used in appropriate doses, have failed due to inefficacy, not intolerance.
* Frequency and Duration: Persistence of disabling seizures at 6 per year or greater for less than two years after onset, or after recurrence if initial treatment resulted in seizure freedom for 6 or more months.
* Age: 12 years or older at baseline visit.
* History: Simple and complex partial seizures, with or without secondarily generalized seizures beginning in childhood or later, with or without febrile convulsions earlier.
* Absence of a history of serious cerebral insult after the age of 5; a progressive neurological disorder; mental retardation (I.Q. less than 70); psychogenic seizures; focal neurological deficits other than memory disturbances; unequivocal focal extratemporal EEG slowing or interictal spikes; or lesions on neuroimaging outside of the mesial temporal area.
* Seizure semiology: Auras that occur in isolation and are not primary sensory other than olfactory or gustatory. Absence of initial focal motor movements other than automatisms or dystonic posturing. Presence of postictal confusion.
* Neurological examination: No unexplained focal or lateralized neurological deficits other than memory dysfunction.
* Baseline QOL and ancillary outcome data:
* Adolescents - QOLIE-48-AD, CHQ, CBCL, PANAS, Life Events Scale, FAC, FEICS-PC completed.
* Adults - QOLIE-82/ESI55, locus…
What they're measuring
1
The primary outcome measure will be freedom from disabling epileptic seizures (complex partial and secondarily generalized seizures, and simple partial seizures that are apparent to an observer)