This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Treatment of Acute Migraine Headache in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00355394
First received: July 19, 2006
Last updated: October 30, 2015
Last verified: October 2015
  Purpose
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.

Condition Intervention Phase
Migrainous Headache Drug: Metoclopramide Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Acute Migraine Headache in Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • The Number of Subjects With a Numeric Rating Scale Score (NRS) of Zero at Two Hours. [ Time Frame: 2 hours ]
    The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.


Secondary Outcome Measures:
  • The Number of Subjects With a NRS Score of Zero at One Hour. [ Time Frame: 1 hour ]
    The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.

  • The Number of Subjects With a NRS Score of Zero at 24 Hours. [ Time Frame: 24 hours ]
    The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.

  • Change in Headache Intensity as Measured by the NRS Score From Baseline to the One Hour Assessment. [ Time Frame: 1 hours ]
    The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.

  • Change in Headache Intensity as Measured by the NRS Score From Baseline to the Two Hour Assessment. [ Time Frame: 2 hours ]
    The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.

  • Change in Headache Intensity as Measured by the NRS Score From Baseline to the 24 Hour Assessment. [ Time Frame: 24 hours ]
    The NRS is a 0 to 10 point scale with 0 representing no headache and 10 representing severe headache.


Enrollment: 31
Study Start Date: August 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Standard care including intravenous fluid, but no metoclopramide.
Other: Placebo
Standard care including intravenous fluid, but no metoclopramide.
Active Comparator: Metoclopramide
Standard care including intravenous fluid PLUS metoclopramide.
Drug: Metoclopramide
Intravenous bolus administration.
Other Name: Reglan

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or Females age 8-18 years
  2. Girls 11 years or older must have a negative urine/serum pregnancy test.
  3. 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:

  1. Evidence that headache is due to a secondary underlying disorder based on history or physical examination.
  2. Pregnant or lactating females.
  3. Any investigational drug use within 30 days.
  4. Known to have a contraindication to metoclopramide or valproic acid such as pregnancy, liver disease, hematologic disease, or metabolic disease.
  5. Have used metoclopramide (or other antidopaminergic medications) or valproic acid within two days of presentation.
  6. Severe developmental disorders or mental retardation if insufficient information can be obtained to make a clear diagnosis of migraine or judge headache severity.
  7. If patients re-present to the ED, they can not be re-enrolled.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355394

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Nicholas S Abend, MD Children's Hospital of Philadelphia
  More Information

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00355394     History of Changes
Other Study ID Numbers: 2006-4-4755
Study First Received: July 19, 2006
Results First Received: January 8, 2013
Last Updated: October 30, 2015

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 21, 2017