A Study of the Prevalence of Headache in Epileptic Patients

Epilepsy Clinical Trial

Official title:

Headache in Epileptic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00277368
• Other study ID #: CR003613
• Status: Completed
• Phase: N/A
• First received: January 13, 2006
• Last updated: April 26, 2010
• Start date: July 2005
• Est. completion date: March 2006

Study information

• Verified date: April 2010
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the prevalence, characteristics and classification of headaches in epileptic patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 719
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Epilepsy
• Headache

Intervention

Other:
• A structured questionnaire for seizure-related headache
A structured questionnaire for seizure-related headache

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of seizure-related headache among epilepsy patients and its classification		At first visit (This study is cross-sectional)	No
Secondary	The pain intensity of seizure-related headache		At 1st visit	No
Secondary	The frequency of seizure-related headache		At 1st visit	No