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A Study of the Prevalence of Headache in Epileptic Patients

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ClinicalTrials.gov Identifier: NCT00277368
Recruitment Status : Completed
First Posted : January 16, 2006
Last Update Posted : April 27, 2010
Sponsor:
Information provided by:
Janssen Korea, Ltd., Korea

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

Condition or disease Intervention/treatment
Epilepsy Other: A structured questionnaire for seizure-related headache

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.

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Study Type : Observational
Actual Enrollment : 719 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Headache in Epileptic Patients
Study Start Date : July 2005
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
001 Other: A structured questionnaire for seizure-related headache
A structured questionnaire for seizure-related headache




Primary Outcome Measures :
  1. Rate of seizure-related headache among epilepsy patients and its classification [ Time Frame: At first visit (This study is cross-sectional) ]

Secondary Outcome Measures :
  1. The pain intensity of seizure-related headache [ Time Frame: At 1st visit ]
  2. The frequency of seizure-related headache [ Time Frame: At 1st visit ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277368


Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
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Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.

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Responsible Party: Clinical Research Director, Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00277368     History of Changes
Other Study ID Numbers: CR003613
First Posted: January 16, 2006    Key Record Dates
Last Update Posted: April 27, 2010
Last Verified: April 2010

Keywords provided by Janssen Korea, Ltd., Korea:
Epilepsy
Headache
Seizure

Additional relevant MeSH terms:
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Epilepsy
Headache
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms