search
Back to results

Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy (RASLOW)

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Rapid withdrawal of antiepileptic
Slow withdrawal of antiepileptic
Sponsored by
University Magna Graecia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Rapid withdrawal

Slow withdrawal

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 18, 2022
Last Updated
February 1, 2022
Sponsor
University Magna Graecia
Collaborators
Ministry of Health, Italy
search

1. Study Identification

Unique Protocol Identification Number
NCT05236166
Brief Title
Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 26, 2017 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Magna Graecia
Collaborators
Ministry of Health, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapid withdrawal
Arm Type
Other
Arm Description
Reduction by about 20 % of initial dosage every 15 days until complete discontinuation (total withdrawal time: 60 days).
Arm Title
Slow withdrawal
Arm Type
Other
Arm Description
Reduction by about 20 % of initial dosage every 40 days, until complete discontinuation (total withdrawal time: 160 days).
Intervention Type
Drug
Intervention Name(s)
Rapid withdrawal of antiepileptic
Other Intervention Name(s)
antiepileptic
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Slow withdrawal of antiepileptic
Other Intervention Name(s)
antiepileptic
Intervention Description
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
Primary Outcome Measure Information:
Title
Time to seizure relapse
Description
Time to recurrence of an epileptic seizure, assesed by telephone call and outpatients visits.
Time Frame
365 days
Secondary Outcome Measure Information:
Title
Patients' compliance with the assigned withdrawal schedule
Description
Compliance with the assigned withdrawal schedule (evaluated by telephone interview) and outpatients visits.
Time Frame
365 days
Title
Severity of relapses and mortality
Description
Severity of relapses, in terms of seizure-related injuries, status epilepticus (SE) during or after withdrawal period, and mortality
Time Frame
365 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Regional Epilepsy Center, Presidio Riuniti, Magna Græcia University of Catanzaro
City
Reggio Calabria
ZIP/Postal Code
89100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19490039
Citation
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.
Results Reference
background
PubMed Identifier
16625621
Citation
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.
Results Reference
background

Learn more about this trial

Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy

We'll reach out to this number within 24 hrs