Phase 4
N=209
Dexamethasone for Migraine - Dose Comparison
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT04112823 ↗Enrolled (actual)
209
Serious AEs
1.0%
Results posted
Mar 2024
Primary outcome: Primary: Number of Subjects With Headaches Who Have Sustained Headache Relief for 48 Hours — 35; 42 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexamethasone 4mg (Drug); Dexamethasone 16mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Headaches Who Have Sustained Headache Relief for 48 Hours |
35; 42 | — |
| SECONDARY Number of Subjects With Headache Who Have Relief Within Two Hours of Medication Administration |
77; 82 | — |
| SECONDARY Additional Headache Medication in the ED |
83; 87; 21; 18 | — |
| SECONDARY Patient Preference for Receiving the Same Medication for a Subsequent Headache |
80; 83; 12; 7; 10; 12 | — |
| SECONDARY Number of Days With Headache |
2; 2 | — |
| SECONDARY Use of Additional Headache Medication After ED Discharge |
55; 60; 45; 41 | — |
Summary
Dexamethasone is an evidence-based treatment of acute migraine. This is a randomized comparison of two different doses of dexamethasone for acute migraine.
All patients will also be treated with metoclopramide.
Eligibility Criteria
Inclusion Criteria
- Moderate or severe migraine
Exclusion Criteria
- Medication contra-indication
- Concern for secondary cause of headache
Data sourced from ClinicalTrials.gov (NCT04112823). 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.