Early Surgical Intervention to Treat Epilepsy
ERSET
Early Randomized Surgical Epilepsy Trial
1 other identifier
interventional
200
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2002
Longer than P75 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2002
CompletedFirst Posted
Study publicly available on registry
June 25, 2002
CompletedStudy Start
First participant enrolled
July 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedFebruary 23, 2010
February 1, 2010
5.3 years
June 24, 2002
February 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
2 years
Study Arms (2)
1
ACTIVE COMPARATORanteromesial temporal resection
2
ACTIVE COMPARATORantiepileptic drugs
Interventions
Eligibility Criteria
You may qualify if:
- 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 of control, PANAS, Life Events Scale, FAD, FEICS-PC completed.
- Global rating scale completed.
- Baseline ancillary outcomes completed. Psychiatric evaluation: No evidence of psychosis, current or recent substance abuse, suicidality, anorexia, or psychogenic seizures. Baseline BSI and MINI or KSADS completed.
- Neuropsychological testing: I.Q. of greater than 70. No significant focal neurocognitive dysfunction inconsistent with MRI and PET findings. Baseline neuropsychological testing completed.
- Neuroimaging: Hippocampal atrophy on MRI T1 imaging with either increased ipsilateral mesial signal on T2 imaging, or ipsilateral hypometabolism on PET (Class I), or either hippocampal atrophy on MRI only, or temporal hypometabolism on PET only (Class II).
- Absence of temporal neocortical or extratemporal lesions on MRI, or diffuse unilateral or bilateral hypometabolism on PET.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
UCLA School of Medicine, Department of Neurology
Los Angeles, California, 90095-1769, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
University of Michigan, Department of Neurology
Ann Arbor, Michigan, 48109-0036, United States
University of Rochester, Department of Neurology
Rochester, New York, 14642, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Vanderbilt University
Nashville, Tennessee, 37212, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Related Publications (1)
Engel J Jr, McDermott MP, Wiebe S, Langfitt JT, Stern JM, Dewar S, Sperling MR, Gardiner I, Erba G, Fried I, Jacobs M, Vinters HV, Mintzer S, Kieburtz K; Early Randomized Surgical Epilepsy Trial (ERSET) Study Group. Early surgical therapy for drug-resistant temporal lobe epilepsy: a randomized trial. JAMA. 2012 Mar 7;307(9):922-30. doi: 10.1001/jama.2012.220.
PMID: 22396514DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jerome Engel, Jr., M.D., Ph.D.
UCLA School of Medicine, Department of Neurology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 24, 2002
First Posted
June 25, 2002
Study Start
July 1, 2002
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
February 23, 2010
Record last verified: 2010-02