NCT05236166

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
Last Updated

February 11, 2022

Status Verified

February 1, 2022

Enrollment Period

4 years

First QC Date

January 18, 2022

Last Update Submit

February 1, 2022

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Time to seizure relapse

    Time to recurrence of an epileptic seizure, assesed by telephone call and outpatients visits.

    365 days

Secondary Outcomes (2)

  • Patients' compliance with the assigned withdrawal schedule

    365 days

  • Severity of relapses and mortality

    365 days

Study Arms (2)

Rapid withdrawal

OTHER

Reduction by about 20 % of initial dosage every 15 days until complete discontinuation (total withdrawal time: 60 days).

Drug: Rapid withdrawal of antiepileptic

Slow withdrawal

OTHER

Reduction by about 20 % of initial dosage every 40 days, until complete discontinuation (total withdrawal time: 160 days).

Drug: Slow withdrawal of antiepileptic

Interventions

Rapid withdrawal of antiepilepticDRUG

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

Also known as: antiepileptic
Rapid withdrawal
Slow withdrawal of antiepilepticDRUG

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

Also known as: antiepileptic
Slow withdrawal

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Epilepsy Center, Presidio Riuniti, Magna Græcia University of Catanzaro

Reggio Calabria, 89100, Italy

Location

Related 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.

    PMID: 19490039BACKGROUND

  • 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: 16625621BACKGROUND

MeSH Terms

Conditions

Epilepsy

Interventions

Anticonvulsants

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Central Nervous System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 18, 2022

First Posted

February 11, 2022

Study Start

April 26, 2017

Primary Completion

May 1, 2021

Study Completion

November 1, 2021

Last Updated

February 11, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)