drugset / Trial / NCT05236166
Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2017-04-26
- Primary completion
- 2021-05-01
- Completion
- 2021-11-01
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carbamazepine | Small molecule | — | — |
| Subject | Lamotrigine | Small molecule | — | — |
| Subject | Levetiracetam | Other / unclassified | — | — |
| Subject | Oxcarbazepine | Small molecule | — | — |
| Subject | Phenobarbital | Unknown | — | — |
| Subject | Phenytoin | Unknown | — | — |
| Subject | Topiramate | Small molecule | — | — |
| Subject | Valproic Acid | Small molecule | — | — |
| Subject | Zonisamide | Other / unclassified | — | — |