EpilepsyNCT00277368
A Study of the Prevalence of Headache in Epileptic Patients
An observational study of Epilepsy, run by Janssen Korea, Ltd., Korea.
Trial summary
The purpose of this study is to investigate the prevalence, characteristics and classification of headaches in epileptic patients. Read more about this study
- Who is it for?
- Ages 13 to 85 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- A structured questionnaire for seizure-related headache
- How many people
- 719 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Mar 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a recent diagnosis epilepsy; able to describe their symptoms by themselves; have had at least 2 episodes of seizures during the previous year; have had at least 1 headache during the previous year.
Who may be able to join
- Patients with a recent diagnosis epilepsy
- Able to describe their symptoms by themselves
- Have had at least 2 episodes of seizures during the previous year
- Have had at least 1 headache during the previous year
Who cannot join
- Well-controlled epileptic patients taking anti-epileptic medications
About this study
Official title: Headache in Epileptic Patients
The purpose of this study is to investigate the prevalence, characteristics and classification of headaches in epileptic patients.
Read the detailed description
Headache is often ignored as a symptom of epileptic seizures. The purpose of this survey is to investigate the prevalence, characteristics and classification of seizure-associated headaches and non-seizure-associated headaches in epileptic patients in Korea, according the criteria of the International Headache Society 2004. In this survey, 577 consecutive patients with a recent diagnosis of epilepsy are interviewed by questionnaire about headaches associated with epileptic seizures. It involves questions about headache in general, localization, severity, duration and frequency, as well as headache associated with seizures, and about patient's family history. This Observational study does not involve the administration of any drugs.
- Conditions
- Epilepsy
- Being tested
- A structured questionnaire for seizure-related headache
- Keywords
- Epilepsy, Headache, Seizure
- Medical subject headings
- Epilepsy, Headache, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A structured questionnaire for seizure-related headacheOther
A structured questionnaire for seizure-related headache
| Study group | Role | What they receive |
|---|---|---|
| 001 | Not described Receives: Other: A structured questionnaire for seizure-related headache |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of seizure-related headache among epilepsy patients and its classification
Measured: At first visit (This study is cross-sectional)
Secondary outcomes (2)
The pain intensity of seizure-related headache
Measured: At 1st visit
The frequency of seizure-related headache
Measured: At 1st visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startJul 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 719 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen Korea, Ltd. Clinical Trial, Study director, Janssen Korea, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277368
- Sponsor's protocol ID
- CR003613
- Status last verified
- Apr 2010
- First submitted
- 13 Jan 2006
- Last updated
- 27 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Headache in Epileptic Patients
- ClinicalTrials.gov ID
- NCT00277368
- Acronym / sponsor ID
- CR003613
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Headache, Seizure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 719 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- Mar 2006 (actual)
- First posted
- 16 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the prevalence, characteristics and classification of headaches in epileptic patients.
Detailed description
Headache is often ignored as a symptom of epileptic seizures. The purpose of this survey is to investigate the prevalence, characteristics and classification of seizure-associated headaches and non-seizure-associated headaches in epileptic patients in Korea, according the criteria of the International Headache Society 2004. In this survey, 577 consecutive patients with a recent diagnosis of epilepsy are interviewed by questionnaire about headaches associated with epileptic seizures. It involves questions about headache in general, localization, severity, duration and frequency, as well as headache associated with seizures, and about patient's family history. This Observational study does not involve the administration of any drugs.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Other: A structured questionnaire for seizure-related headache |
Who may qualify
- Ages
- 13 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a recent diagnosis epilepsy; able to describe their symptoms by themselves; have had at least 2 episodes of seizures during the previous year; have had at least 1 headache during the previous year.
Key inclusion criteria (4 listed)
- Patients with a recent diagnosis epilepsy
- Able to describe their symptoms by themselves
- Have had at least 2 episodes of seizures during the previous year
- Have had at least 1 headache during the previous year
Key exclusion criteria (1 listed)
- Well-controlled epileptic patients taking anti-epileptic medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A structured questionnaire for seizure-related headacheA structured questionnaire for seizure-related headache | Other | 001 |
Primary outcome
Rate of seizure-related headache among epilepsy patients and its classification
Time frame: At first visit (This study is cross-sectional)
2 secondary outcomes
The pain intensity of seizure-related headache
Time frame: At 1st visit
The frequency of seizure-related headache
Time frame: At 1st visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Korea, Ltd. Clinical Trial study director
Janssen Korea, Ltd.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Janssen Korea, Ltd., Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of seizure-related headache among epilepsy patients and its classification (time frame: At first visit (This study is cross-sectional)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2010.