Pilot Study to Collect and Evaluate Data on the Use of IV* Ibuprofen in the Treatment of an Acute Migraine Attack
Summary
This is a pilot trial to collect data on the use of intravenous ibuprofen (IVIb) in the treatment of an acute migraine attack. Data will be collected on the efficacy of IVIb in subjects who are treated with study medication between 2 and 72 hours from time of onset of headache. Periodic safety and efficacy assessments will be performed prior to and after study drug administration. Null hypothesis: There is no difference in the proportion of subjects in the 2 treatment groups (active treatment and placebo) who have pain relief at 2 hours after the completion of the double-blind treatment infusion. Pain relief is defined as a reduction in headache pain level from severe or moderate decreased to mild or headache-free, respectively.
Timeline
- Start
- 2011-06
- Primary completion
- 2017-06
- Completion
- 2017-07
Outcome
Missed primary endpoint
registry p = 0.078; Odds Ratio (OR) 3.12 (95% CI 0.88 to 11.0); Regression, Logistic NCT01230411 ↗
paper This study did not meet the primary endpoint PMID 34601736 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibuprofen | Small molecule | 800 mg | Intravenous |