Treatment of Acute Migraine Headache in Children

NCT00355394 | Completed Phase 2 Results

• 1 other identifier: 2006-4-4755
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Migrainous Headache

Outcome Measures

Primary Outcomes (1)

• The Number of Subjects With a Numeric Rating Scale Score (NRS) of Zero at Two Hours.

  The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.

  2 hours

Secondary Outcomes (5)

• The Number of Subjects With a NRS Score of Zero at One Hour.

  1 hour

• The Number of Subjects With a NRS Score of Zero at 24 Hours.

  24 hours

• Change in Headache Intensity as Measured by the NRS Score From Baseline to the One Hour Assessment.

  1 hours

• Change in Headache Intensity as Measured by the NRS Score From Baseline to the Two Hour Assessment.

  2 hours

• Change in Headache Intensity as Measured by the NRS Score From Baseline to the 24 Hour Assessment.

  24 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Standard care including intravenous fluid, but no metoclopramide.

Other: Placebo

Metoclopramide

ACTIVE COMPARATOR

Standard care including intravenous fluid PLUS metoclopramide.

Drug: Metoclopramide

Interventions

Metoclopramide DRUG

Intravenous bolus administration.

Also known as: Reglan

Metoclopramide

Placebo OTHER

Standard care including intravenous fluid, but no metoclopramide.

Placebo

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Metoclopramide

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Limitations and Caveats

Study was performed in tertiary care setting and may not be generalizable to all settings. Small number of subjects (n=31). None admitted or received additional rescue medication, suggesting most severely affected may not have been enrolled.

Results Point of Contact

• Title: Dr. Nicholas Abend
• Organization: CHOP

abend@email.chop.edu

215-590-1719

Study Officials

• Nicholas S Abend, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2006
• First Posted: July 21, 2006
• Study Start: August 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: November 30, 2015
• Results First Posted: August 30, 2013

Record last verified: 2015-10

Locations

US (1)