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Treatment of Acute Migraine Headache in Children
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Children's Hospital of Philadelphia.   Recruitment status was  Recruiting

First Received on July 19, 2006.   Last Updated on July 16, 2008   History of Changes
Sponsor: Children's Hospital of Philadelphia
Information provided by: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00355394
  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 propose a prospective, double-blind, placebo-controlled, cross-over study of metoclopramide versus placebo in the treatment of acute migraine headache with open-label rescue using valproic acid. The primary outcome will be the number of patients who are pain free at two hours. The use of a standardized rescue medication will provide exploratory data for possible future trials. Clinical experience is that many children do not experience headache relief with first line medications such as metoclopramide or experience rapid recurrence of headache. Prior data has demonstrated that many children with headache have co-morbid anxiety, depression or other psychological co-morbidities. There has been little investigation of these psychological co-morbidities in children with migraine headache although clinical experience and limited investigations suggest that when these co-morbidities are addressed some children with refractory headache improve. We prose a descriptive study of these co-morbidities in children presenting with acute migraine, and a comparison of medication efficacy among children with and without psychological co-morbidity.


Condition Intervention Phase
Migraine Headache
Drug: Metoclopramide
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 primary endpoint will be a change in NRS score from baseline value to zero at two hours. Thus, the primary endpoint is headache resolution at two hours. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change in NRS score from baseline value to zero at one hour for headache intensity. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • The change in NRS score by 6 points from baseline to 2 hour value for headache intensity. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • The change in NRS score by 3 points from baseline to 2 hour value for headache intensity. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • The change in NRS score by 6 points from baseline to 2 hour value for associated symptoms. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • The change in NRS score for "Migraine Free" category which is change in NRS score for headache intensity and associated symptoms from baseline to two hour value. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • The change in NRS score from two hour measurement to follow-up at 1 day and 7 days [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • The percent of children who have not responded to metoclopramide who do respond to rescue medication (valproic acid). [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • The change in NRS score from baseline to zero at one hour for headache intensity. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • The change in NRS score from baseline to zero at two hours for headache intensity/ [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • The change in NRS score by 6 points from baseline to 2 hour value for associated symptoms [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • The percent of children with psychological co-morbidity (anxiety and depression) presenting with acute migraine headache. [ Time Frame: 0 ] [ Designated as safety issue: No ]
  • The percent of children who become headache free at two hours with and without psychological comorbidity. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: August 2006
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Metoclopramide
    Intravenous bolus administration.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
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 ICDH 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355394

Contacts
Contact: Nicholas S Abend, MD 215-590-1719 abend@email.chop.edu

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Sub-Investigator: Nicholas S Abend, MD            
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nichoals S Abend, MD     215-590-1719        
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Donald Younkin, MD Children's Hospital of Philadelphia
  More Information

No publications provided

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
Last Updated: July 16, 2008
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012