Epilepsy MedDRA version: 20.0 Level: LLT Classification code 10015046 Term: Epilepsy, unspecified System Organ Class: 100000004852
Conditions
Interventions
Trade Name: KEPPRA - 1000MG-COMPRESSA RIVESTITA CON FILM-USO ORALE BLISTER DIVISIBILE (ALLUMINIO/PVC)-100X1 (DOSE UNITARIA)
Pharmaceutical Form: Tablet
Current Sponsor code: non applicabile
Other desc
Sponsors
AZIENDA OSPEDALIERA "BIANCHI-MELACRINO-MORELLI"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age at inclusion 18+ years; 2) Diagnosis of epilepsy (according to ILAE 1989 criteria); 3) Age at epilepsy onset of 16 years or older; 4) Seizure freedom for at least 2 years; 5) Current treatment with one of the AEDs available for monotherapy available in Italy (carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid, zonisamide); 6) Ability to understand and comply with the study requirements and to give written informed consent; 7) Current drug is the active principle contributing to the achievement of seizure remission regardless of the indication and the tolerability profile; 8) Absence of any contraindication and special warning for the current antiepileptic drug. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1) Inability to understand the aims or modalities of the study; 2) Current pregnancy or plans to become pregnant during withdrawal period (e.g. who are not post menopausal, surgically sterile, or using inadequate birth control); 3) History of seizure relapse after discontinuation of treatment; 4) History of psychogenic non-epileptic seizures (PNES); 5) History of status epilepticus; 6) Poor compliance with previous treatments; 7) Experimental treatments in previous 3 months; 8) Men unable to practice contraception for the duration of the treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the present study will be to establish whether a slow or a rapid withdrawal schedule of antiepileptic monotherapy influence relapse rate in adult patients with epilepsy, who have been seizure-free for at least two years.;Primary end point(s): The primary endpoint is the time to recurrence of an epileptic seizure. ;Timepoint(s) of evaluation of this end point: Anytime during the study;Secondary Objective: Secondary objectives will be to establish the compliance rates with these two schedules and the differences in terms of severity of relapses, based on occurrence of status epilepticus, seizure-related injuries and death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are the compliance with the assigned withdrawal schedule and the severity of relapses, in terms of seizure-related injuries (contusions, wounds, fractures, strain/sprain, head injury, burns, whiplash), status epilepticus (SE) during or after withdrawal period, and mortality.;Timepoint(s) of evaluation of this end point: Anytime during the study | — |
Countries
Italy
Contacts
Public ContactLABORATORIO MALATTIE NEUROLOGICHE
IRCCS ISTITUTO DI RICERCHE FARMACOLOGICHE "MARIO NEGRI" DI MILANO
Outcome results
None listed