Status:
COMPLETED
Treatment of Acute Migraine Headache in Children
Lead Sponsor:
Children's Hospital of Philadelphia
Conditions:
Migrainous Headache
Eligibility:
All Genders
8-18 years
Phase:
PHASE2
Brief Summary
Migraine is common in children and is one of the most common etiologies of headache leading to emergency room presentation in children. Despite this, few studies have investigated the treatment of acu...
Detailed Description
Migraine is common in children and is one of the most common etiologies of headache leading to emergency room presentation of children \[1-3\]. Despite the high prevalence, there have been few pediatr...
Eligibility Criteria
Inclusion
- Males or Females age 8-18 years
- Girls 11 years or older must have a negative urine/serum pregnancy test.
- Diagnosis of pediatric migrainous headache. The criteria for pediatric migraine headache based on the most recent ICHD criteria are listed below. The requirement of 5 attacks (A) will not be required for this study, this making the diagnosis migrainous headache. As described elsewhere in the protocol, this change is required to make the study applicable to ED patients who require treatment before five attacks have occurred.
Exclusion
- Evidence that headache is due to a secondary underlying disorder based on history or physical examination.
- Pregnant or lactating females.
- Any investigational drug use within 30 days.
- Known to have a contraindication to metoclopramide or valproic acid such as pregnancy, liver disease, hematologic disease, or metabolic disease.
- Have used metoclopramide (or other antidopaminergic medications) or valproic acid within two days of presentation.
- Severe developmental disorders or mental retardation if insufficient information can be obtained to make a clear diagnosis of migraine or judge headache severity.
- If patients re-present to the ED, they can not be re-enrolled.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00355394
Start Date
August 1 2006
End Date
March 1 2010
Last Update
November 30 2015
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104