Idiopathic Generalized Epilepsy Syndromes

Recruiting

• Conditions: Epilepsy; Epilepsy, Idiopathic Generalized

• Registration Number: NCT06388174
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

The idiopathic generalized epilepsies (IGEs) have historically included the syndromes childhood absence epilepsy (CAE), juvenile absence epilepsy (JAE), juvenile myoclonic epilepsy (JME), and epilepsy with generalized tonic-clonic seizures alone (GTCA). Recognition of the IGEs is important for clinical care, as it informs diagnosis, prevents unnecessary investigation, allows optimal selection of anti-seizure medications (ASMs), and provides prognostic guidance.

According to the new ILAE definition in 2022, the study aims to describe the clinical features, electroencephalographic, imaging findings and long-term prognosis.

Detailed Description

the Long-term prognosis include the rate of drug-resistent epilepsy, relapse after drug withdrawn, common comorbidities such as mood disorders, attention deficit hyperactivity disorder (ADHD) and learning disabilities.

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-24
• Last Update Submitted: 2024-04-24
• Study First Posted: 2024-04-29
• Last Update Posted: 2024-04-29
• Primary Completion: 2026-12-31
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients are consecutively and prospectively enrolled from epilepsy center, with newly diagnosed epilepsy or established epilepsy.
• Patients have a diagnosis of idiopathic generalized epilepsy (IGE), according to the 2022 diagnostic criteria.
• Comprehensive clinical information is collected, and 24 hour video-electroencephalography is performed.
• Sign the informed consent forms.

Exclusion Criteria

• Other epilepsy syndromes are considered during follow-up, such as genetic generalized epilepsy.
• Lost to follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of seizure freedom	through study completion, an average of 1 year	We defined seizure freedom according to the International League Against Epilepsy (ILAE) definition
The proportion of drug-resistent epilepsy	through study completion, an average of 1 year	We defined drug-resistant cases as those patients who have failed two or more trials of broad-spectrum ASMs or those otherwise indicated in IGE syndromes

Secondary Outcome Measures

Name	Time	Method
The proportion of psychiatric comorbidity	through study completion, an average of 1 year	The psychiatric comorbidities mainly include anxiety and depression, which are evaluated by Hamilton anxiety scale and Hamilton depression scale, respectively.
The proportion of psychosocial outcome	through study completion, an average of 1 year	such as university entrance, marry
The proportion of seizure relapse after antiseizure medication withdrawn	through study completion, an average of 1 year	Antiseizure medication withdrawn should be recommended by epilepsy experts

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hangzhou, Zhejiang, China