Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy

NCT05236166 — Not applicable, Completed, 48 participants, University Magna Graecia

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Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy in 2-year Seizure-free Adult Patients With Epilepsy (RASLOW) Study: a Pragmatic Multicentre, Prospective, Randomized, Controlled Study

Registry	NCT05236166, acronym RASLOW
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	48 (Actual)
Sponsor	University Magna Graecia (Other); collaborators: Ministry of Health, Italy
Conditions	Epilepsy
Interventions	Rapid withdrawal of antiepileptic, Slow withdrawal of antiepileptic (Drug)
Dates	start 2017-04-26, primary completion 2021-05-01, completion 2021-11-01, first posted 2022-02-11, last updated 2022-02-11
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Rapid withdrawal	Other	Drug: Rapid withdrawal of antiepileptic	Reduction by about 20 % of initial dosage every 15 days until complete discontinuation (total withdrawal time: 60 days).
Slow withdrawal	Other	Drug: Slow withdrawal of antiepileptic	Reduction by about 20 % of initial dosage every 40 days, until complete discontinuation (total withdrawal time: 160 days).

Rapid withdrawal of antiepileptic (Drug), also known as antiepileptic: 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
Slow withdrawal of antiepileptic (Drug), also known as antiepileptic: 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

+Outcome measures

Primary outcomes

Time to seizure relapse [365 days]: Time to recurrence of an epileptic seizure, assesed by telephone call and outpatients visits.

Secondary outcomes

Patients' compliance with the assigned withdrawal schedule [365 days]: Compliance with the assigned withdrawal schedule (evaluated by telephone interview) and outpatients visits.
Severity of relapses and mortality [365 days]: Severity of relapses, in terms of seizure-related injuries, status epilepticus (SE) during or after withdrawal period, and mortality

+Eligibility

Sex: All, ages: 16 Years to any

Inclusion Criteria:

* diagnosis of focal or generalized epilepsy (according to International League Against Epilepsy 1989 criteria)
* age at epilepsy onset of 16 years or older
* seizure freedom for at least 2 years
* treatment with one of the antiepilepsy drugs currently available for monotherapy in Italy: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid zonisamide)
* adherence to the protocol and visit schedules.

Exclusion Criteria:

* inability to understand the aims or modalities of the study;
* current pregnancy or plans to become pregnant during withdrawal period;
* history of seizure relapse after discontinuation of treatment;
* history of psychogenic non-epileptic seizures (PNES);
* history of status epilepticus

+Locations (1)

Facility	City	Country	Status
Regional Epilepsy Center, Presidio Riuniti, Magna Græcia University of Catanzaro	Reggio Calabria	Italy

+Publications

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. PMID 19490039
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. PMID 16625621

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