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RASLOW: Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy

Sponsor
University Magna Graecia (Other)
Overall Status
Completed
CT.gov ID
NCT05236166
Collaborator
Ministry of Health, Italy (Other)
48
Enrollment
1
Location
2
Arms
54.2
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Rapid withdrawal of antiepileptic
  • Drug: Slow withdrawal of antiepileptic
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 26, 2017
Actual Primary Completion Date :
May 1, 2021
Actual Study Completion Date :
Nov 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Rapid withdrawal

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

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
Other Names:
  • antiepileptic

    		•
    Other: Slow withdrawal

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

    Drug: 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
    Other Names:
  • antiepileptic

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to seizure relapse [365 days]

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

    Secondary Outcome Measures

    1. Patients' compliance with the assigned withdrawal schedule [365 days]

      Compliance with the assigned withdrawal schedule (evaluated by telephone interview) and outpatients visits.

    2. 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 Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Regional Epilepsy Center, Presidio Riuniti, Magna Græcia University of Catanzaro Reggio Calabria Italy 89100

    Sponsors and Collaborators

    • University Magna Graecia
    • Ministry of Health, Italy

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Edoardo Ferlazzo, Professor, University Magna Graecia
    ClinicalTrials.gov Identifier:
    NCT05236166
    Other Study ID Numbers:
    • GR-2013-02358677
    First Posted:
    Feb 11, 2022
    Last Update Posted:
    Feb 11, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Epilepsy
    Anticonvulsants

    Study Results

    No Results Posted as of Feb 11, 2022