- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06388174
Idiopathic Generalized Epilepsy Syndromes
Idiopathic Generalized Epilepsy Syndromes: Clinical Features and Long-term Outcomes
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Chunhong Shen
- Phone Number: +86 0571 87783872
- Email: shen_neurology@zju.edu.cn
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Recruiting
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
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Contact:
- Chunhong Shen
- Phone Number: +86 0571 87783872
- Email: shen_neurology@zju.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The proportion of drug-resistent epilepsy
Time Frame: 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
|
through study completion, an average of 1 year
|
|
The proportion of seizure freedom
Time Frame: through study completion, an average of 1 year
|
We defined seizure freedom according to the International League Against Epilepsy (ILAE) definition
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The proportion of psychiatric comorbidity
Time Frame: 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.
|
through study completion, an average of 1 year
|
|
The proportion of psychosocial outcome
Time Frame: through study completion, an average of 1 year
|
such as university entrance, marry
|
through study completion, an average of 1 year
|
|
The proportion of seizure relapse after antiseizure medication withdrawn
Time Frame: through study completion, an average of 1 year
|
Antiseizure medication withdrawn should be recommended by epilepsy experts
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chunhong Shen, Second Affiliated Hospital, School of Medicine, Zhejiang University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S2022-0336
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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