Phase 2
N=44
Normobaric Oxygen (NBO) Therapy in Acute Migraine
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT01542307 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS) — 1.38; 1.22 units on a scale — p=0.674
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oxygen (Biological); Room air (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS) |
1.38; 1.22 | 0.674 |
| SECONDARY Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS) |
0.77; 0.44 | 0.18 |
| SECONDARY Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS) |
2.05; 1.57 | 0.38 |
| SECONDARY Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS) |
24; 6 | 0.05 |
| SECONDARY Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS) |
45; 23 | 0.05 |
| SECONDARY Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS) |
36; 6 | 0.004 sig |
| SECONDARY Final Nausea Score 0-1 on the Visual Analog Scale (VAS) |
64; 65 | 1.00 |
Summary
This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in acute migraine headache.
Eligibility Criteria
Inclusion Criteria
- Adult subjects with frequent migraine (at least 1 attack per month)
Exclusion Criteria
- Secondary (non-migraine) headache
- Chronic obstructive pulmonary disease
- Pregnant
Data sourced from ClinicalTrials.gov (NCT01542307). 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.