A Phase 2 interventional study of Oxygen and Room air in Migraine, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-27.
Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment
This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in acute migraine headache.
A total of 40 adult subjects will be enrolled, male and female. Subjects will be consented to inhale either Normobaric Oxygen (NBO) or Room air for 30 minutes at the start of their migraine attacks. Outcomes will be assessed during and after gas treatment.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 22 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oxygen is inhaled for 30 minutes during migraine attack
Biological: Oxygen
Medical air inhaled for 30 minutes during migraine attack
Biological: Room air
Oxygen is inhaled for 30 minutes during migraine attack
Placebo
Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS)
The mean change in VAS pain scores from 0 minutes to 30 minutes was selected as the primary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
Time frame: From baseline (0 minutes) to 30 mins
Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS)
The mean change in VAS pain scores from 0 minutes to 15 minutes was selected as a secondary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
Time frame: Baseline (0 minutes) to 15 minutes
Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS)
The mean change in VAS pain scores from 0 minutes to 60 minutes was selected as a secondary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
Time frame: Baseline (0 minutes) to 60 minutes
Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS)
The percentage of migraine attacks with the final (60 minute) VAS pain score 0-1 was selected as a secondary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
Time frame: 60 minutes
Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS)
The percentage of migraine attacks with the final (60 minute) VAS pain score either 0-1, or a 3-point improvement from baseline, was selected as a secondary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
Time frame: 60 minutes
Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS)
The percentage of migraine attacks with the final (60 minute) VAS visual symptom score 0-1 was selected as a secondary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
Time frame: 60 minutes
Final Nausea Score 0-1 on the Visual Analog Scale (VAS)
The percentage of migraine attacks with the final (60 minute) VAS nausea score 0-1 was selected as a secondary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
Time frame: 60 minutes
Post-gas Therapy Medication Use
The percentage of migraine attacks requiring the use of one or more anti-migraine medications after the period of gas inhalation, was selected as a secondary outcome measure.
Time frame: 60 minutes
22 subjects enrolled
| Milestone | Oxygen-treated Migraine Attacks | Medical Air-treated Migraine Attacks |
|---|---|---|
| Started | 22 | 22 |
| Completed | 22 | 22 |
| Not completed | 0 | 0 |
The mean change in VAS pain scores from 0 minutes to 30 minutes was selected as the primary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
| units on a scale | Oxygen | Room Air |
|---|---|---|
| Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS) | 1.38 ± 1.42 | 1.22 ± 1.61 |
The mean change in VAS pain scores from 0 minutes to 15 minutes was selected as a secondary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
| units on a scale | Oxygen | Room Air |
|---|---|---|
| Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS) | 0.77 ± 1.09 | 0.44 ± 0.92 |
The mean change in VAS pain scores from 0 minutes to 60 minutes was selected as a secondary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
| units on a scale | Oxygen | Room Air |
|---|---|---|
| Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS) | 2.05 ± 2.23 | 1.57 ± 1.94 |
The percentage of migraine attacks with the final (60 minute) VAS pain score 0-1 was selected as a secondary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
| percentage of attacks | Oxygen | Room Air |
|---|---|---|
| Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS) | 24 | 6 |
The percentage of migraine attacks with the final (60 minute) VAS pain score either 0-1, or a 3-point improvement from baseline, was selected as a secondary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
| percentage of attacks | Oxygen | Room Air |
|---|---|---|
| Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS) | 45 | 23 |
The percentage of migraine attacks with the final (60 minute) VAS visual symptom score 0-1 was selected as a secondary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
| percentage of attacks | Oxygen | Room Air |
|---|---|---|
| Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS) | 36 | 6 |
The percentage of migraine attacks with the final (60 minute) VAS nausea score 0-1 was selected as a secondary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
| percentage of attacks | Oxygen | Room Air |
|---|---|---|
| Final Nausea Score 0-1 on the Visual Analog Scale (VAS) | 64 | 65 |
The percentage of migraine attacks requiring the use of one or more anti-migraine medications after the period of gas inhalation, was selected as a secondary outcome measure.
| percentage of attacks | Oxygen | Room Air |
|---|---|---|
| Post-gas Therapy Medication Use | 36 | 52 |
Collected over Adverse events were collected from the time of enrollment and until a maximum of 4 migraine attacks were treated with gas inhalation and study equipment returned to the study team.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oxygen | — | 0/22 (0%) | 2/22 (9.1%) |
| Room Air | — | 0/22 (0%) | 2/22 (9.1%) |
| Event | Oxygen | Room Air |
|---|---|---|
| Significant worsening of migraine headacheNervous system disorders | 0/22 | 2/22 |
| Dry MouthGeneral disorders | 1/22 | 0/22 |
| TinglingNervous system disorders | 1/22 | 0/22 |
Enrolled subjects
| Age, Continuous(years) | Enrolled Subjects |
|---|---|
| Mean | 36 ± 10 |
| Sex: Female, Male(Participants) | Enrolled Subjects |
|---|---|
| Female | 20 |
| Male | 2 |
| Race/Ethnicity, Customized(Participants) | Enrolled Subjects |
|---|---|
| Caucasian | 20 |
| Non-Caucasian | 2 |
| Region of Enrollment(Participants) | Enrolled Subjects |
|---|---|
| United States | 22 |
| Migraine(Participants) | Enrolled Subjects |
|---|---|
| Migraine w Aura | 7 |
| Migraine without Aura | 15 |
| Employment(Participants) | Enrolled Subjects |
|---|---|
| Employed Full Time | 17 |
| Not Employed Full Time | 5 |
| Education Level(Participants) | Enrolled Subjects |
|---|---|
| College or higher | 20 |
| School or lower | 2 |
| Marital status(Participants) | Enrolled Subjects |
|---|---|
| Married | 10 |
| Single | 12 |
11 further baseline measures are reported on the registry.
Plan to share: Undecided
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Massachusetts General Hospital