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Study on Migraine and Headache in Epileptic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00642564
Recruitment Status : Completed
First Posted : March 25, 2008
Last Update Posted : May 23, 2014
Information provided by (Responsible Party):
Johnson & Johnson Taiwan Ltd

Brief Summary:
The purpose of this study is to collect data from patients who are diagnosed with epilepsy and are followed up in epilepsy clinics.

Condition or disease Intervention/treatment
Epilepsy Other: Observational study in Epileptic Patients

Detailed Description:
Headaches and epilepsy are chronic disorders with episodic manifestations characterized by recurrent attacks of nervous system dysfunction with a return to baseline between attacks. Although it is not uncommon that patients with epilepsy suffer from headaches, the relations between seizures and headaches is multi-factorial. Headaches may occur immediately before (preictal), during (ictal), or after (postictal) a seizure. In addition to seizure-associated headaches, patients often experience headaches that are not temporally related to seizures-interictal headaches. Moreover, epidemiological studies indicate an association of migraine and epilepsy with an increased prevalence of migraine in patients with epilepsy. Up to now, there is still limited information about the relationship between the frequency of seizure attacks and headache occurrences. Thus, we purpose this study to investigate the incidence of headaches, to explore the relationship between seizure attacks and headache occurrences, to classify the headache, and to document the frequency, characteristics, and effects of migraine and headaches among patients with epilepsy. This study is a multi-centre survey to collect data from patients who are diagnosed with epilepsy and are followed up in epilepsy clinics. Patients can only participate in this study after signing and dating the inform consents. There are two stages of this study: Stage I: On enrollment, data on demographic characteristics, epilepsy profile, seizure frequencies, and epilepsy treatment would be obtained. Body weight and height would be measured. Information of prior headache occurrences and their relationships with seizures would also be collected. Stage II: Patients enrolled into this study will be divided into three group: patients who are seizure free for past 6 months, patients with > 1 attack every month within past 6 months, and other patients. Participants of each group will be enrolled into Stage II for 24-week follow-up. Information of seizure attacks, headache occurrences, and treatment will be collected. This is an observational study and no study drug is administered.

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Study Type : Observational
Actual Enrollment : 955 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : February 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
001 Other: Observational study in Epileptic Patients
Observation study in Epileptic Patients with Migraine and Headache

Primary Outcome Measures :
  1. To determine the prevalence and the frequencies of migraines and other types of headache among patients with epilepsy, and to explore the relationship between seizure frequencies and headache occurrences [ Time Frame: Participants of each group will be enrolled for 24-week follow-up. ]

Secondary Outcome Measures :
  1. A decreased number of seizure symptoms as noted by the improved score on the 10-point Visual Analog Scale [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study will enroll patients with diagnosis of epilepsy and age should be equal or more than 7 years old.

Inclusion Criteria:

  • Patients diagnosed with epilepsy
  • Patients or parent(s)/caregiver(s) have signed and dated an informed consent.

Exclusion Criteria:

  • Patients who have non-epileptic events in addition to epilepsy, such as pseudoseizures or an acute symptomatic cause of seizures (e.g., a metabolic disturbance, toxic exposure, active CNS infection)
  • Patients with progressive or degenerative neurological disorder
  • Patients with an active malignancy
  • Patients or parents/caregivers with known or suspected psychotic disease, mental retardation, or any mental situation which may cause the concern to properly complete this survey.

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 identifier (NCT number): NCT00642564

Sponsors and Collaborators
Johnson & Johnson Taiwan Ltd
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Study Director: Johnson & Johnson Taiwan, Ltd. Clinical Trial Johnson & Johnson Taiwan Ltd
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Responsible Party: Johnson & Johnson Taiwan Ltd Identifier: NCT00642564    
Other Study ID Numbers: CR014668
First Posted: March 25, 2008    Key Record Dates
Last Update Posted: May 23, 2014
Last Verified: May 2014
Keywords provided by Johnson & Johnson Taiwan Ltd:
Additional relevant MeSH terms:
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Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Headache Disorders, Primary
Headache Disorders
Neurologic Manifestations