Efficacy of Levetiracetam In pedatrics migrain headache
Phase 3
Recruiting
- Conditions
- Migraine.G43Migraine
- Registration Number
- IRCT20160802029171N3
- Lead Sponsor
- Hamedan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 39
Inclusion Criteria
Migraine headache according to ICHD-3 criteria
The patient's age of 5-15 years
Written consent from the patient or his parents/guardians
Normal radiological and neurological findings
Exclusion Criteria
Recent history of head trauma
Drug abuse
Having a secondary headache due to infection(Otitis media or sinusitis,..)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Headache Severity: indicates the pain caused by the headache. Grade 0 means no pain, Grade 1 means mild pain, Grade 2 means moderate pain and Grade 3 means severe pain. Timepoint: 1 month. Method of measurement: Headache severity is measured based on headache score.;Headache frequency: indicates repetition of headache attacks per 24 hours, week or month. Timepoint: 1 month. Method of measurement: headache frequency will be measured with asking question from patient and his parents.;Headache disability: indicates the number of days that a person can not perform his or her daily tasks due to a headache. Timepoint: 1 month. Method of measurement: Headache disability will be measured with based on pediatric migraine disability assessment.
- Secondary Outcome Measures
Name Time Method Sleepiness: a feeling of being sleepy and lethargic. Timepoint: 1 month. Method of measurement: Sleepiness will be measured by asking question from childs and/or their parents.;Agitation: a state of anxiety or nervous excitement. Timepoint: 1 month. Method of measurement: Agitation will be measured by asking question from childs and/or their parents and clinical experiments.