Rapid versus slow withdrawal of antiepileptci monotherapy in two-year seizure free patients.

Phase 1

• Conditions: Epilepsy; MedDRA version: 20.0Level: LLTClassification code 10015046Term: Epilepsy, unspecifiedSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-004827-30-IT
• Lead Sponsor: AZIENDA OSPEDALIERA BIANCHI-MELACRINO-MORELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-30
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 350

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified