A Study of the Prevalence of Headache in Epileptic Patients
April 26, 2010 updated by: Janssen Korea, Ltd., Korea
Headache in Epileptic Patients
The purpose of this study is to investigate the prevalence, characteristics and classification of headaches in epileptic patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Headache is often ignored as a symptom of epileptic seizures.
The purpose of this survey is to investigate the prevalence, characteristics and classification of seizure-associated headaches and non-seizure-associated headaches in epileptic patients in Korea, according the criteria of the International Headache Society 2004.
In this survey, 577 consecutive patients with a recent diagnosis of epilepsy are interviewed by questionnaire about headaches associated with epileptic seizures.
It involves questions about headache in general, localization, severity, duration and frequency, as well as headache associated with seizures, and about patient's family history.
This Observational study does not involve the administration of any drugs.
Study Type
Observational
Enrollment (Actual)
719
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 85 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with a recent diagnosis epilepsy; able to describe their symptoms by themselves; have had at least 2 episodes of seizures during the previous year; have had at least 1 headache during the previous year.
Description
Inclusion Criteria:
- Patients with a recent diagnosis epilepsy
- Able to describe their symptoms by themselves
- Have had at least 2 episodes of seizures during the previous year
- Have had at least 1 headache during the previous year
Exclusion Criteria:
- Well-controlled epileptic patients taking anti-epileptic medications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
001
|
A structured questionnaire for seizure-related headache
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of seizure-related headache among epilepsy patients and its classification
Time Frame: At first visit (This study is cross-sectional)
|
At first visit (This study is cross-sectional)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The pain intensity of seizure-related headache
Time Frame: At 1st visit
|
At 1st visit
|
|
The frequency of seizure-related headache
Time Frame: At 1st visit
|
At 1st visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Study Completion (Actual)
March 1, 2006
Study Registration Dates
First Submitted
January 13, 2006
First Submitted That Met QC Criteria
January 13, 2006
First Posted (Estimate)
January 16, 2006
Study Record Updates
Last Update Posted (Estimate)
April 27, 2010
Last Update Submitted That Met QC Criteria
April 26, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR003613
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.