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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06388174
Other study ID # S2022-0336
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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the Long-term prognosis include the rate of drug-resistent epilepsy, relapse after drug withdrawn, common comorbidities such as mood disorders, attention deficit hyperactivity disorder (ADHD) and learning disabilities.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
Accepts healthy volunteers
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

Study Design


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
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