EpilepsyNCT06388174
Idiopathic Generalized Epilepsy Syndromes
An observational study of Epilepsy and Epilepsy, Idiopathic Generalized, run by Shen Chun-Hong at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 4 to 40 years
- Conditions the study is for
- Epilepsy, Epilepsy, Idiopathic Generalized
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 40 years
- All sexes
- Child, Adult
Study population: Patients are consecutively and prospectively recruited from epilepsy center and clinics
Who may be able to join
- 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.
Who cannot join
- Other epilepsy syndromes are considered during follow-up, such as genetic generalized epilepsy.
- Lost to follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310000
Chunhong Shen, +86 0571 87783872, shen_neurology@zju.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy, Epilepsy, Idiopathic Generalized
- Medical subject headings
- Epilepsy, Epilepsy, Idiopathic Generalized
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
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.
Measured: through study completion, an average of 1 year
The proportion of psychosocial outcome
such as university entrance, marry
Measured: through study completion, an average of 1 year
The proportion of seizure relapse after antiseizure medication withdrawn
Antiseizure medication withdrawn should be recommended by epilepsy experts
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shen Chun-Hong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shen Chun-Hong, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Chunhong Shen, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388174
- Sponsor's protocol ID
- S2022-0336
- Status last verified
- Aug 2025
- First submitted
- 16 Apr 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiopathic Generalized Epilepsy Syndromes: Clinical Features and Long-term Outcomes
- ClinicalTrials.gov ID
- NCT06388174
- Acronym / sponsor ID
- S2022-0336
- Conditions
- Epilepsy, Epilepsy, Idiopathic Generalized
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shen Chun-HongUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 40 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients are consecutively and prospectively recruited from epilepsy center and clinics
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Other epilepsy syndromes are considered during follow-up, such as genetic generalized epilepsy.
- Lost to follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
3 secondary outcomes
The proportion of psychiatric comorbidity
Time frame: through study completion, an average of 1 year
The proportion of psychosocial outcome
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chunhong Shen principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Epilepsy, Idiopathic Generalized, run by Shen Chun-Hong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunhong Shen (+86 0571 87783872, shen_neurology@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of drug-resistent epilepsy (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.