Treatment of Acute Migraine Headache in Children

Completed · Phase 2 · Has a placebo group

Conditions studied: Migrainous Headache

In brief

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 acute migraine headache in the emergency room. We will perform a prospective, double-blind, placebo-controlled study of metoclopramide versus placebo in the treatment of acute migraine headache. The primary outcome will be the number of subjects headache free at two hours.

Key facts

Study ID

NCT00355394

Run by

Children's Hospital of Philadelphia

People needed

31

Starts

2006-08-01

Expected to finish

2010-03-01

Last updated by the study team

2015-11-30

Who can join

Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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