NCT06388174

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
93mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Jan 2023Dec 2033

Study Start

First participant enrolled

January 1, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2033

Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

4 years

First QC Date

April 16, 2024

Last Update Submit

August 20, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • The proportion of drug-resistent epilepsy

    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

    through study completion, an average of 1 year

  • The proportion of seizure freedom

    We defined seizure freedom according to the International League Against Epilepsy (ILAE) definition

    through study completion, an average of 1 year

Secondary Outcomes (3)

  • The proportion of psychiatric comorbidity

    through study completion, an average of 1 year

  • The proportion of psychosocial outcome

    through study completion, an average of 1 year

  • The proportion of seizure relapse after antiseizure medication withdrawn

    through study completion, an average of 1 year

Eligibility Criteria

Age4 Years - 40 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients are consecutively and prospectively recruited from epilepsy center and clinics

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

EpilepsyEpilepsy, Idiopathic Generalized

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Chunhong Shen

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Senior Doctor

Study Record Dates

First Submitted

April 16, 2024

First Posted

April 29, 2024

Study Start

January 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2033

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations