Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT00355394
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT00355394
Study Brief:
Protocol Section:
NCT00355394