Idiopathic Generalized Epilepsy Syndromes

Epilepsy Clinical Trial

Official title:

Idiopathic Generalized Epilepsy Syndromes: Clinical Features and Long-term Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06388174
• Other study ID #: S2022-0336
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2033

Study information

• Verified date: April 2024
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Chunhong Shen
• Phone: +86 0571 87783872
• Email: shen_neurology[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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the Long-term prognosis include the rate of drug-resistent epilepsy, relapse after drug withdrawn, common comorbidities such as mood disorders, attention deficit hyperactivity disorder (ADHD) and learning disabilities.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2033
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: 4 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Generalized
• Epilepsy, Idiopathic Generalized
• Epileptic Syndromes

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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Secondary	The proportion of seizure relapse after antiseizure medication withdrawn	Antiseizure medication withdrawn should be recommended by epilepsy experts	through study completion, an average of 1 year