EpilepsyNCT04944641
Epilepsy Prevalence and Intervention Study in Zhejiang Province, China
A study testing education on epilepsy and routine and proper antiepileptic drugs in people with Epilepsy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial summary
To carry out the epidemiological investigation on epilepsy in Zhejiang Province, China, and then establish early comprehensive intervention to help patients with epilepsy to improve seizure control and the quality of life. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- education on epilepsy and routine and proper antiepileptic drugs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 13 Sep 2013to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed and untreated epilepsy; Aged 14 and above; Sign the informed consents.
Who cannot join
- With intellectual development disorder; With serious heart and lung diseases.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang
Mei-ping Ding, 13588058581, dmp-neurology@zju.edu.cn
- Completed
Shengzhou People's Hospital
Shengzhou
About this study
To carry out the epidemiological investigation on epilepsy in Zhejiang Province, China, and then establish early comprehensive intervention to help patients with epilepsy to improve seizure control and the quality of life.
Read the detailed description
To carry out the epidemiological investigation on epilepsy in Zhejiang Province, China, and then establish early comprehensive intervention（proper antiepileptic drugs and education intervention） to help patients with epilepsy to improve seizure control and the quality of life.
- Conditions
- Epilepsy
- Being tested
- education on epilepsy, routine and proper antiepileptic drugs
- Keywords
- epilepsy prevalence, intervention
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education on epilepsyBehavioural
education on epilepsy, including epilepsy diary, pamphlet，discussion between patients and phone visits and so on
routine and proper antiepileptic drugsDrug
routine and proper antiepileptic drugs
| Study group | Role | What they receive |
|---|---|---|
| A: Routine AED group | Experimental | Routine and proper antiepileptic drugs group Receives: Drug: routine and proper antiepileptic drugs |
| B: AED and education group | Experimental | Routine, proper antiepileptic drugs and education group Receives: Behavioral: education on epilepsy; Drug: routine and proper antiepileptic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline seizures frequency 1
change from baseline seizures frequency at 12 months, seizure frequency is defined as the number of seizure attacks during 3 months before baseline or endpoint)
Measured: 12 months
Change from baseline seizures frequency 2
change from baseline seizures frequency at 24 months, seizure frequency is defined as the number of seizure attacks during 3 months before baseline or endpoint)
Measured: 24 months
Occurrence of refractory epilepsy
occurrence of refractory epilepsy at 24 months
Measured: 24 months
Secondary outcomes (1)
Quality of life (QOL scales)
Quality of Life Scale, high scores mean a better outcome
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start13 Sep 2013
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomly group into two
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Center of Disease Control and Prevention, The Central Hospital of Lishui City, The Second Affiliated Hospital of Jiaxing University, Zhejiang University, The Children's Hospital of Zhejiang University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944641
- Sponsor's protocol ID
- 2013-032
- Status last verified
- Jul 2021
- First submitted
- 8 Jun 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epilepsy Prevalence and Intervention Study in Zhejiang Province, China
- ClinicalTrials.gov ID
- NCT04944641
- Acronym / sponsor ID
- 2013-032
- Conditions
- Epilepsy
- Keywords
- epilepsy prevalence, intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Hangzhou Center of Disease Control and Prevention, The Central Hospital of Lishui City, The Second Affiliated Hospital of Jiaxing University, Zhejiang University, The Children's Hospital of Zhejiang University School of Medicine
- Study start
- 13 Sep 2013 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 29 Jun 2021 (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.
To carry out the epidemiological investigation on epilepsy in Zhejiang Province, China, and then establish early comprehensive intervention to help patients with epilepsy to improve seizure control and the quality of life.
Detailed description
To carry out the epidemiological investigation on epilepsy in Zhejiang Province, China, and then establish early comprehensive intervention（proper antiepileptic drugs and education intervention） to help patients with epilepsy to improve seizure control and the quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomly group into two
| Arm | Type | Receives |
|---|---|---|
| A: Routine AED group | Experimental | Drug: routine and proper antiepileptic drugsRoutine and proper antiepileptic drugs group |
| B: AED and education group | Experimental | Behavioral: education on epilepsy, Drug: routine and proper antiepileptic drugsRoutine, proper antiepileptic drugs and education group |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Newly diagnosed and untreated epilepsy; Aged 14 and above; Sign the informed consents.
Key exclusion criteria (1 listed)
- With intellectual development disorder; With serious heart and lung diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| education on epilepsyeducation on epilepsy, including epilepsy diary, pamphlet，discussion between patients and phone visits and so on | Behavioural | B: AED and education group |
| routine and proper antiepileptic drugsroutine and proper antiepileptic drugs | Drug | A: Routine AED group, B: AED and education group |
Primary outcome
Change from baseline seizures frequency 1
Time frame: 12 months
change from baseline seizures frequency at 12 months, seizure frequency is defined as the number of seizure attacks during 3 months before baseline or endpoint)
Change from baseline seizures frequency 2
Time frame: 24 months
change from baseline seizures frequency at 24 months, seizure frequency is defined as the number of seizure attacks during 3 months before baseline or endpoint)
Occurrence of refractory epilepsy
Time frame: 24 months
occurrence of refractory epilepsy at 24 months
1 secondary outcome
Quality of life (QOL scales)
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education on epilepsy and routine and proper antiepileptic drugs in people with Epilepsy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mei-ping Ding (13588058581, dmp-neurology@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline seizures frequency 1 (time frame: 12 months). The study lists 3 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 19 Jul 2021.