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Study on Migraine and Headache in Epileptic Patients

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ClinicalTrials.gov Identifier: NCT00642564
Recruitment Status : Completed
First Posted : March 25, 2008
Last Update Posted : May 23, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Taiwan Ltd

Tracking Information
First Submitted Date March 21, 2008
First Posted Date March 25, 2008
Last Update Posted Date May 23, 2014
Study Start Date February 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 4, 2009)
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. ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00642564 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 4, 2009)
A decreased number of seizure symptoms as noted by the improved score on the 10-point Visual Analog Scale [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study on Migraine and Headache in Epileptic Patients
Official Title MIGRAINE AND HEADACHE IN EPILEPTIC PATIENTS
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Epilepsy
Intervention Other: Observational study in Epileptic Patients
Observation study in Epileptic Patients with Migraine and Headache
Study Groups/Cohorts 001
Intervention: Other: Observational study in Epileptic Patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 4, 2009)
955
Original Estimated Enrollment
 (submitted: March 21, 2008)
1200
Actual Study Completion Date March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00642564
Other Study ID Numbers CR014668
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Johnson & Johnson Taiwan Ltd
Study Sponsor Johnson & Johnson Taiwan Ltd
Collaborators Not Provided
Investigators
Study Director: Johnson & Johnson Taiwan, Ltd. Clinical Trial Johnson & Johnson Taiwan Ltd
PRS Account Johnson & Johnson Taiwan Ltd
Verification Date May 2014