Phase 2
N=31
Treatment of Acute Migraine Headache in Children
Migrainous Headache
Bottom Line
View on ClinicalTrials.gov: NCT00355394 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: The Number of Subjects With a Numeric Rating Scale Score (NRS) of Zero at Two Hours. — 5; 12 participants — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Metoclopramide (Drug); Placebo (Other)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Subjects With a Numeric Rating Scale Score (NRS) of Zero at Two Hours. |
5; 12 | 0.03 sig |
| SECONDARY The Number of Subjects With a NRS Score of Zero at One Hour. |
1; 9 | 0.02 sig |
| SECONDARY The Number of Subjects With a NRS Score of Zero at 24 Hours. |
4; 7 | 0.46 |
| SECONDARY Change in Headache Intensity as Measured by the NRS Score From Baseline to the One Hour Assessment. |
-2.5; -6.8 | 0.002 sig |
| SECONDARY Change in Headache Intensity as Measured by the NRS Score From Baseline to the Two Hour Assessment. |
-4.9; -7.8 | 0.01 sig |
| SECONDARY Change in Headache Intensity as Measured by the NRS Score From Baseline to the 24 Hour Assessment. |
-4.5; -5.6 | 0.50 |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00355394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.