Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy

Epilepsy Clinical Trial

— RASLOW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05236166
• Other study ID #: GR-2013-02358677
• Status: Completed
• Phase: N/A
• Start date: April 26, 2017
• Est. completion date: November 1, 2021

Study information

• Verified date: February 2022
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Rapid withdrawal of 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
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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University Magna Graecia	Ministry of Health, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

Ranganathan LN, Ramaratnam S. Rapid versus slow withdrawal of antiepileptic drugs. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005003. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to seizure relapse	Time to recurrence of an epileptic seizure, assesed by telephone call and outpatients visits.	365 days
Secondary	Patients' compliance with the assigned withdrawal schedule	Compliance with the assigned withdrawal schedule (evaluated by telephone interview) and outpatients visits.	365 days
Secondary	Severity of relapses and mortality	Severity of relapses, in terms of seizure-related injuries, status epilepticus (SE) during or after withdrawal period, and mortality	365 days