Clinical trial NCT00642564: Study on Migraine and Headache in Epileptic Patients
Official title: MIGRAINE AND HEADACHE IN EPILEPTIC PATIENTS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Epilepsy
Headache
Migraine
Lead sponsor: Johnson & Johnson Taiwan Ltd
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 955
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Participants of each group will be enrolled for 24-week follow-up.
Secondary outcomes:
measure: A decreased number of seizure symptoms as noted by the improved score on the 10-point Visual Analog Scale
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Taiwan Ltd
name: Johnson & Johnson Taiwan, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: