Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040326
Status:
COMPLETED
Last Update Posted:
2010-02-23
First Post:
2002-06-24
Brief Title:
Early Surgical Intervention to Treat Epilepsy
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Early Randomized Surgical Epilepsy Trial
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERSET
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
Detailed Description:
Mesial temporal lobe epilepsy MTLE is the most common form of epilepsy and the most medically intractable An estimated one-quarter to one-half of the 400000 patients in the United States with intractable epilepsy have MTLE Generally MTLE becomes intractable in adolescence and early adulthood Persistence of seizures during this time commonly causes adverse social and psychological consequences which can become irreversible
The current treatment of MTLE primarily consists of medications to control seizures Usually surgical treatment is considered only if medications are not effective Recent studies have shown that surgery can stop disabling seizures in 60 to 70 of patients with long standing MTLE However to date no research study has examined surgery performed as an early therapy
The goal of the study is to determine if more patients treated with early surgery become seizure free and have improved quality of life compared to similar patients who continue to receive antiepileptic medication only This study will determine the difference in seizure frequency between the two groups and the impact of the two treatments on the quality of life of the participants
The current treatment of MTLE primarily consists of medications to control seizures Usually surgical treatment is considered only if medications are not effective Recent studies have shown that surgery can stop disabling seizures in 60 to 70 of patients with long standing MTLE However to date no research study has examined surgery performed as an early therapy
The goal of the study is to determine if more patients treated with early surgery become seizure free and have improved quality of life compared to similar patients who continue to receive antiepileptic medication only This study will determine the difference in seizure frequency between the two groups and the impact of the two treatments on the quality of life of the participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None