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| 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 |
| 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) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 8 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Nicholas S Abend, MD | 215-590-1719 | abend@email.chop.edu |
| 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 | |
| Principal Investigator: | Donald Younkin, 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 |
| Last Updated: | July 16, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
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 |