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Migraine and High Flow Oxygenotherapy at the Emergency Department (MiOx)

Study acronym: MiOx
StatusRecruiting
PhasePhase 4
Started2023-10-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 18, 2024 (before its estimated April 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2024-11-15
minor
Study Status v5
Primary completion date2024-10→2025-04
Completion date2024-10→2025-04
2023-10-25
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-08→2024-10
Completion date2024-08→2024-10
Start dateestimated 2023-09→confirmed 2023-10-01
Study sitesdetails revised at 1 of 1 site
2023-07-28
minor
Study Status v3
Primary completion date2024-06→2024-08
Completion date2024-06→2024-08
Start date2023-07→2023-09
2023-06-13
minor
Study Status v2
Primary completion date2022-06→2024-06
Completion date2022-06→2024-06
Start date2021-09→2023-07
2021-07-05
minor
Study Status, Outcome Measures, Contacts/Locations v1
Secondary endpointsdetails revised at 1 of 5 entries
Study sitescontacts updated at 1 of 1 site
2021-06-04
minor
Original filing
Migraine is a common pathology, affecting around 12% of the general population, up to 25% in some cohorts, as well as a significant part of the reasons for emergency room visits. Unlike cluster headaches, the use of high-flow oxygen therapy has not yet been validated in patients with migraine. However, several aspects of its pathophysiology, still studied to this day, suggest that the use of normobaric oxygen could have beneficial effects on migraine attacks: tissue hypoxia, cerebrovascular dysfunction with vasodilation, inflammation, etc. In addition, high-flow oxygen therapy has no significant side effects and almost no contraindication (mainly COPD and other chronic respiratory failure) Its use in the event of a migraine attack would thus allow less recourse to conventional analgesics (with significant side effects for some), a shorter stay in the emergency room, and therefore a benefit in terms of cost and relief for the patient. In this context, the sponsor wish to carry out a multicenter prospective interventional, single-blind randomized placebo-controlled in parallel groups study.
Trial Details
NCT Number NCT04925414
Lead Sponsor Centre Hospitalier Universitaire de Nice
Conditions Migraine
Enrollment 70 participants
Start Date 2023-10-01
Primary Completion 2025-04 (estimated)
Study Completion 2025-04 (estimated)
Updated on ClinicalTrials.gov 2024-11-18