Last updated: 02/07/2020 16:20:20

Characteristics of out-patients with epilepsy and patterns of antiepileptic drug utilisation in neurology department at tertiary hospitals: A Cross-Sectional Study in China

GSK study ID
200713
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Characteristics of out-patients with epilepsy and patterns of antiepileptic drug utilisation in neurology department at tertiary hospitals: A Cross-Sectional Study in China
Trial description: This is an observational, hospital-based cross-sectional epidemiology study conducted at various tertiary hospitals across China. The patients attending general neurologists as well as epileptologists of the epilepsy clinics will be consecutively invited for this study. Around 1600 eligible patients with confirmed epilepsy will be included and evaluated during the study, after obtaining the signed written informed consent. All the patients will have only one clinic visit and the following data will be collected during the visit: details of medical history, demography, type(s) of seizure and epilepsy according to the International League against Epilepsy classification [Commissions, 1981, Commissions, 1989], electroclinical syndrome[Berg AT, 2010], seizure frequency, Epilepsy etiologies, comorbidities, details of current and previous AED regimen (names of drug, dose, mono or poly and dosages),the adverse effects which may have led to the drug withdrawal (if any), the reason of drug adjustment and the treatment plan.
Inclusion criteria
• Male and female subjects with any age
• Confirmed diagnosis of epilepsy by review of medical records(clinical, EEG and/or neuroimaging findings) according to the International Classification of Epileptic Seizures (1981)
• Previously untreated for epilepsy, previously treated for epilepsy, or currently is taking epilepsy medication
• A written informed consent must be obtained prior to any study related procedures
Exclusion criteria
• Subject has a current or previous diagnosis of pseudoseizures or other non-epileptic ictal events that could be confused with seizures
• In the opinion of the investigator the patients who are not likely to be reliable , cooperative and compliant with study procedures
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

6. The most frequent dual combination

Timeframe: at the end of the study

4. Patterns of AEDs prescribed(type of therapy: mono, dual, triple, older/newer AED)

Timeframe: at the end of the study

7.The percentage of patients remain seizure free

Timeframe: at the end of the study

2. Seizure type

Timeframe: at the end of the study

5. The most frequent AEDs as monotherapy

Timeframe: at the end of the study

1. Demographic characteristics

Timeframe: at the end of the study

3. Seizure frequency for uncontrolled patients

Timeframe: at the end of the study

Secondary outcomes:

the factors influencing the utilization of the most commonly prescribed AEDs

Timeframe: at the end of the study

9. Differences in frequency of utilization of individual AEDs between groups(Seizure types, gender, age)

Timeframe: at the end of the study

8. Overall AED utilization(Percentage of patient of individual AEDs and AED combinations )

Timeframe: at the end of the study

Differences of average daily dose of AEDs compared with 50% DDD in patients≥16 years old

Timeframe: at the end of the study

Differences of average daily dose of AEDs between patients who are seizure free and uncontrolled

Timeframe: at the end of the study

Interventions:
Not applicable
Enrollment:
1603
Primary completion date:
2014-14-11
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Peimin Yu, Dong Zhou, Weiping Liao, Xin Wang, Yuping Wang, Tiancheng Wang, Yuan Wu, Senyang Lang, Weihong Lin, Yijun Song, Heqing Zhao, Meng Cai, Zhen Hong. An investigation of the characteristics of out-patients with epilepsy and antiepileptic drug utilization in a multicenter cross-sectional study in China. Epilepsy Behav. 2017;69:126-132.
Medical condition
Epilepsy
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
May 2014 to November 2014
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
  • Male and female subjects with any age
  • Confirmed diagnosis of epilepsy by review of medical records(clinical, EEG and/or neuroimaging findings) according to the International Classification of Epileptic Seizures (1981)
  • Subject has a current or previous diagnosis of pseudoseizures or other non-epileptic ictal events that could be confused with seizures
  • In the opinion of the investigator the patients who are not likely to be reliable , cooperative and compliant with study procedures

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Beijing, China, 100053
Status
Study Complete
Location
GSK Investigational Site
Beijing, China, 100853
Status
Study Complete
Location
GSK Investigational Site
Changchun, Jilin, China, 130021
Status
Study Complete
Location
GSK Investigational Site
Chengdu, China, 610041
Status
Study Complete
Location
GSK Investigational Site
Guangzhou, Guangdong, China, 510260
Status
Study Complete
Location
GSK Investigational Site
Lanzhou, Gansu, China
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
2014-14-11
Actual study completion date
2014-14-11

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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