EpilepsyRASLOWNCT05236166
Multicentre Study on Rapid Versus Slow Withdrawal of Antiepileptic Monotherapy
A study testing Rapid withdrawal of antiepileptic and Slow withdrawal of antiepileptic in people with Epilepsy, run by University Magna Graecia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Rapid withdrawal of antiepileptic and Slow withdrawal of antiepileptic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 26 Apr 2017to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Regional Epilepsy Center, Presidio Riuniti, Magna Græcia University of Catanzaro
Reggio Calabria, 89100
About this study
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
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.
- Conditions
- Epilepsy
- Being tested
- Rapid withdrawal of antiepileptic, Slow withdrawal of antiepileptic
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid withdrawal of antiepilepticDrug
Also called 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 antiepilepticDrug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Rapid withdrawal | Other | Reduction by about 20 % of initial dosage every 15 days until complete discontinuation (total withdrawal time: 60 days). Receives: 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). Receives: Drug: Slow withdrawal of antiepileptic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to seizure relapse
Time to recurrence of an epileptic seizure, assesed by telephone call and outpatients visits.
Measured: 365 days
Secondary outcomes (2)
Patients' compliance with the assigned withdrawal schedule
Compliance with the assigned withdrawal schedule (evaluated by telephone interview) and outpatients visits.
Measured: 365 days
Severity of relapses and mortality
Severity of relapses, in terms of seizure-related injuries, status epilepticus (SE) during or after withdrawal period, and mortality
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start26 Apr 2017
- Primary completion1 May 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Principal investigator, Edoardo Ferlazzo, University Magna Graecia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236166
- Sponsor's protocol ID
- GR-2013-02358677
- Acronym
- RASLOW
- Status last verified
- Feb 2022
- First submitted
- 18 Jan 2022
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19490039Ranganathan 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.
PubMed 16625621
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05236166
- Acronym / sponsor ID
- RASLOW / GR-2013-02358677
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid withdrawal | Other | Drug: Rapid withdrawal of antiepilepticReduction by about 20 % of initial dosage every 15 days until complete discontinuation (total withdrawal time: 60 days). |
| Slow withdrawal | Other | Drug: Slow withdrawal of antiepilepticReduction by about 20 % of initial dosage every 40 days, until complete discontinuation (total withdrawal time: 160 days). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid withdrawal of antiepilepticAlso: antiepilepticReduction 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 | Drug | Rapid withdrawal |
| Slow withdrawal of antiepilepticAlso: antiepilepticSlow 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 | Drug | Slow withdrawal |
Primary outcome
Time to seizure relapse
Time frame: 365 days
Time to recurrence of an epileptic seizure, assesed by telephone call and outpatients visits.
2 secondary outcomes
Patients' compliance with the assigned withdrawal schedule
Time frame: 365 days
Severity of relapses and mortality
Time frame: 365 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Background: PubMed 19490039Del 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.
- Background: PubMed 16625621Ranganathan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid withdrawal of antiepileptic and Slow withdrawal of antiepileptic in people with Epilepsy, run by University Magna Graecia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to seizure relapse (time frame: 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05236166, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.