Epilepsy Prevalence and Intervention Study in Zhejiang Province, China

Epilepsy Clinical Trial

Official title:

Epilepsy Prevalence and Intervention Study in Zhejiang Province, China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04944641
• Other study ID #: 2013-032
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2013
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Mei-ping Ding
• Phone: 13588058581
• Email: dmp-neurology[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

Newly diagnosed and untreated epilepsy; Aged 14 and above; Sign the informed consents.

Exclusion Criteria:

With intellectual development disorder; With serious heart and lung diseases.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Behavioral:
• education on epilepsy
education on epilepsy, including epilepsy diary, pamphlet,discussion between patients and phone visits and so on

Drug:
• routine and proper antiepileptic drugs
routine and proper antiepileptic drugs

Locations

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

Sponsors (6)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Children's Hospital Affiliated to Zhejiang University School of Medicine, Hangzhou Center of Disease Control and Prevention, Shengzhou People's Hospital, The Central Hospital of Lishui City, the second hospital of Jiaxing city

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 months
Primary	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)	24 months
Primary	Occurrence of refractory epilepsy	occurrence of refractory epilepsy at 24 months	24 months
Secondary	Quality of life (QOL scales)	Quality of Life Scale, high scores mean a better outcome	2 year