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Study on Migraine and Headache in Epileptic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier:
NCT00642564
First received: March 21, 2008
Last updated: May 22, 2014
Last verified: May 2014
  Purpose
The purpose of this study is to collect data from patients who are diagnosed with epilepsy and are followed up in epilepsy clinics.

Condition Intervention Phase
Epilepsy Other: Observational study in Epileptic Patients Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: MIGRAINE AND HEADACHE IN EPILEPTIC PATIENTS

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Taiwan Ltd:

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

Enrollment: 955
Study Start Date: February 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001 Other: Observational study in Epileptic Patients
Observation study in Epileptic Patients with Migraine and Headache

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

Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
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.
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642564

Sponsors and Collaborators
Johnson & Johnson Taiwan Ltd
Investigators
Study Director: Johnson & Johnson Taiwan, Ltd. Clinical Trial Johnson & Johnson Taiwan Ltd
  More Information

Responsible Party: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier: NCT00642564     History of Changes
Other Study ID Numbers: CR014668
Study First Received: March 21, 2008
Last Updated: May 22, 2014

Keywords provided by Johnson & Johnson Taiwan Ltd:
Epilepsy
Headache
Migraine

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

ClinicalTrials.gov processed this record on September 21, 2017