NCT00642564

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
955

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

May 23, 2014

Status Verified

May 1, 2014

Enrollment Period

1.1 years

First QC Date

March 21, 2008

Last Update Submit

May 22, 2014

Conditions

Epilepsy

Keywords

EpilepsyHeadacheMigraine

Outcome Measures

Primary Outcomes (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

    Participants of each group will be enrolled for 24-week follow-up.

Secondary Outcomes (1)

  • A decreased number of seizure symptoms as noted by the improved score on the 10-point Visual Analog Scale

    24 weeks

Study Arms (1)

001

Other: Observational study in Epileptic Patients

Interventions

Observational study in Epileptic PatientsOTHER

Observation study in Epileptic Patients with Migraine and Headache

001

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will enroll patients with diagnosis of epilepsy and age should be equal or more than 7 years old.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

EpilepsyHeadacheMigraine Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, PrimaryHeadache Disorders

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Johnson & Johnson Taiwan, Ltd. Clinical Trial

    Johnson & Johnson Taiwan Ltd

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2008

First Posted

March 25, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

May 23, 2014

Record last verified: 2014-05