Phase 3
N=205
Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT00122278 ↗Enrolled (actual)
205
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Persistent Headache Pain Free at 24 Hours — 26; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexamethasone (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Aug 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Persistent Headache Pain Free at 24 Hours |
26; 19 | — |
| SECONDARY Functional Disability at 24 Hours |
70; 55 | — |
Summary
Migraines are a specific type of headache that frequently recur and are very painful. Although there are many medications that are effective against migraines, none of these medications cure 100% of migraines. Another problem with migraines is that although many times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3 of the time migraines recur the next day. The purpose of this research project is to see if adding a medication called dexamethasone to standard ER therapy will help patients get better quicker and stay pain-free more often than if they receive placebo.
Eligibility Criteria
Inclusion Criteria
- Migraine with or without aura; probable migraine without aura
Exclusion Criteria
- Secondary headache
- Allergy, contraindication or intolerance to study medication
Data sourced from ClinicalTrials.gov (NCT00122278). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.