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| Name | Class |
|---|---|
| Ministry of Health, Italy | OTHER_GOV |
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The main objective of the present study will be to establish whether a slow (within 160 days) or a rapid (within 60 days) withdrawal schedule of antiepileptic monotherapy influence relapse rate in adult patients with epilepsy, who have been seizure free for at least 2 years. Secondary objectives will be to establish the compliance rates with these two schedules and the differences in terms of severity of relapses, based on the occurrence of status epilepticus, seizure-related injuries and death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid withdrawal | Other | Reduction by about 20 % of initial dosage every 15 days until complete discontinuation (total withdrawal time: 60 days). |
|
| Slow withdrawal | Other | Reduction by about 20 % of initial dosage every 40 days, until complete discontinuation (total withdrawal time: 160 days). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid withdrawal of antiepileptic | Drug | Reduction by about 20 % of initial dosage every 15 days until complete discontinuation (total withdrawal time: 60 days). Drugs: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid, zonisamide |
| Measure | Description | Time Frame |
|---|---|---|
| Time to seizure relapse | Time to recurrence of an epileptic seizure, assesed by telephone call and outpatients visits. | 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' compliance with the assigned withdrawal schedule | Compliance with the assigned withdrawal schedule (evaluated by telephone interview) and outpatients visits. | 365 days |
| Severity of relapses and mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Epilepsy Center, Presidio Riuniti, Magna Græcia University of Catanzaro | Reggio Calabria | 89100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19490039 | Background | Del Felice A, Beghi E, Boero G, La Neve A, Bogliun G, De Palo A, Specchio LM. Early versus late remission in a cohort of patients with newly diagnosed epilepsy. Epilepsia. 2010 Jan;51(1):37-42. doi: 10.1111/j.1528-1167.2009.02141.x. Epub 2009 Jun 1. | |
| 16625621 | Background | Ranganathan LN, Ramaratnam S. Rapid versus slow withdrawal of antiepileptic drugs. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005003. doi: 10.1002/14651858.CD005003.pub2. |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000927 | Anticonvulsants |
| ID | Term |
|---|---|
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Slow withdrawal of antiepileptic | Drug | Slow withdrawal: reduction by about 20 % of initial dosage every 40 days, until complete discontinuation (total withdrawal time: 160 days). Drugs: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid, zonisamide |
|
|
Severity of relapses, in terms of seizure-related injuries, status epilepticus (SE) during or after withdrawal period, and mortality
| 365 days |