- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00642564
Study on Migraine and Headache in Epileptic Patients
May 22, 2014 updated by: Johnson & Johnson Taiwan Ltd
MIGRAINE AND HEADACHE IN EPILEPTIC PATIENTS
The purpose of this study is to collect data from patients who are diagnosed with epilepsy and are followed up in epilepsy clinics.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
955
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
7 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
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
|
Observation study in Epileptic Patients with Migraine and Headache
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
Participants of each group will be enrolled for 24-week follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
A decreased number of seizure symptoms as noted by the improved score on the 10-point Visual Analog Scale
Time Frame: 24 weeks
|
24 weeks
|
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
February 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
March 21, 2008
First Submitted That Met QC Criteria
March 21, 2008
First Posted (Estimate)
March 25, 2008
Study Record Updates
Last Update Posted (Estimate)
May 23, 2014
Last Update Submitted That Met QC Criteria
May 22, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR014668
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.
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