Trial Outcomes & Findings for Normobaric Oxygen (NBO) Therapy in Acute Migraine (NCT NCT01542307)

Last Updated: 2017-03-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

From baseline (0 minutes) to 30 mins

Results posted on

2017-03-27

Participant Flow

22 subjects enrolled

22 subjects enrolled - each subject generated data for one or more migraine attacks.

Unit of analysis: migraine attacks

Participant milestones

Participant milestones
Measure	Oxygen-treated Migraine Attacks Oxygen is inhaled for 30 minutes during a migraine attack	Medical Air-treated Migraine Attacks Medical air is inhaled for 30 minutes during a migraine attack
Overall Study STARTED	22 33	22 31
Overall Study COMPLETED	22 33	22 30
Overall Study NOT COMPLETED	0 0	0 1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Normobaric Oxygen (NBO) Therapy in Acute Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enrolled Subjects n=22 Participants Oxygen or Medical Air is inhaled in random order for 30 minutes during each migraine attack (total 4 attacks)
Age, Continuous	36 years STANDARD_DEVIATION 10 • n=93 Participants
Sex: Female, Male Female	20 Participants n=93 Participants
Sex: Female, Male Male	2 Participants n=93 Participants
Race/Ethnicity, Customized Caucasian	20 Participants n=93 Participants
Race/Ethnicity, Customized Non-Caucasian	2 Participants n=93 Participants
Region of Enrollment United States	22 Participants n=93 Participants
Migraine Migraine w Aura	7 Participants n=93 Participants
Migraine Migraine without Aura	15 Participants n=93 Participants
Employment Employed Full Time	17 Participants n=93 Participants
Employment Not Employed Full Time	5 Participants n=93 Participants
Education Level College or higher	20 Participants n=93 Participants
Education Level School or lower	2 Participants n=93 Participants
Marital status Married	10 Participants n=93 Participants
Marital status Single	12 Participants n=93 Participants
Smoking Status Prior smoker	2 Participants n=93 Participants
Smoking Status Non-smoker	20 Participants n=93 Participants
Family history of migraine Present	13 Participants n=93 Participants
Family history of migraine Absent	9 Participants n=93 Participants
Vascular risk factors (eg. hypertension) Present	2 Participants n=93 Participants
Vascular risk factors (eg. hypertension) Absent	20 Participants n=93 Participants
One or more lifetime ED visits Yes	17 Participants n=93 Participants
One or more lifetime ED visits None	5 Participants n=93 Participants
One or more ED visits in prior year Visited	11 Participants n=93 Participants
One or more ED visits in prior year Not visited	11 Participants n=93 Participants
Triptans for acute migraine Using	18 Participants n=93 Participants
Triptans for acute migraine Not Using	4 Participants n=93 Participants
NSAIDs/acetaminophen for acute migraine Using	22 Participants n=93 Participants
NSAIDs/acetaminophen for acute migraine Not Using	0 Participants n=93 Participants
Opioids for acute migraine Using	6 Participants n=93 Participants
Opioids for acute migraine Not Using	16 Participants n=93 Participants
Anti-seizure meds for migraine prevention Using	10 Participants n=93 Participants
Anti-seizure meds for migraine prevention Not Using	12 Participants n=93 Participants
Beta-blockers for migraine prevention Using	8 Participants n=93 Participants
Beta-blockers for migraine prevention Not Using	14 Participants n=93 Participants
Using botulinum toxin for migraine prevention Using	4 Participants n=93 Participants
Using botulinum toxin for migraine prevention Not Using	18 Participants n=93 Participants

PRIMARY outcome

Timeframe: From baseline (0 minutes) to 30 mins

Population: Number of migraine attacks treated with Oxygen or Medical Air

Outcome measures

Outcome measures
Measure	Oxygen n=33 Migraine attacks Oxygen is inhaled for 30 minutes during migraine attack Oxygen: Oxygen is inhaled for 30 minutes during migraine attack	Room Air n=31 Migraine attacks Medical air inhaled for 30 minutes during migraine attack Room air: Placebo
Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS)	1.38 units on a scale Standard Deviation 1.42	1.22 units on a scale Standard Deviation 1.61

SECONDARY outcome

Timeframe: Baseline (0 minutes) to 15 minutes

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.

Outcome measures

Outcome measures
Measure	Oxygen n=33 Migraine attacks Oxygen is inhaled for 30 minutes during migraine attack Oxygen: Oxygen is inhaled for 30 minutes during migraine attack	Room Air n=31 Migraine attacks Medical air inhaled for 30 minutes during migraine attack Room air: Placebo
Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS)	0.77 units on a scale Standard Deviation 1.09	0.44 units on a scale Standard Deviation 0.92

SECONDARY outcome

Timeframe: Baseline (0 minutes) to 60 minutes

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.

Outcome measures

Outcome measures
Measure	Oxygen n=33 Migraine attacks Oxygen is inhaled for 30 minutes during migraine attack Oxygen: Oxygen is inhaled for 30 minutes during migraine attack	Room Air n=31 Migraine attacks Medical air inhaled for 30 minutes during migraine attack Room air: Placebo
Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS)	2.05 units on a scale Standard Deviation 2.23	1.57 units on a scale Standard Deviation 1.94

SECONDARY outcome

Timeframe: 60 minutes

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.

Outcome measures

Outcome measures
Measure	Oxygen n=33 Migraine attacks Oxygen is inhaled for 30 minutes during migraine attack Oxygen: Oxygen is inhaled for 30 minutes during migraine attack	Room Air n=31 Migraine attacks Medical air inhaled for 30 minutes during migraine attack Room air: Placebo
Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS)	24 percentage of attacks	6 percentage of attacks

SECONDARY outcome

Timeframe: 60 minutes

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.

Outcome measures

Outcome measures
Measure	Oxygen n=33 Migraine attacks Oxygen is inhaled for 30 minutes during migraine attack Oxygen: Oxygen is inhaled for 30 minutes during migraine attack	Room Air n=31 Migraine attacks Medical air inhaled for 30 minutes during migraine attack Room air: Placebo
Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS)	45 percentage of attacks	23 percentage of attacks

SECONDARY outcome

Timeframe: 60 minutes

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.

Outcome measures

Outcome measures
Measure	Oxygen n=33 Migraine attacks Oxygen is inhaled for 30 minutes during migraine attack Oxygen: Oxygen is inhaled for 30 minutes during migraine attack	Room Air n=31 Migraine attacks Medical air inhaled for 30 minutes during migraine attack Room air: Placebo
Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS)	36 percentage of attacks	6 percentage of attacks

SECONDARY outcome

Timeframe: 60 minutes

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.

Outcome measures

Outcome measures
Measure	Oxygen n=33 Migraine attacks Oxygen is inhaled for 30 minutes during migraine attack Oxygen: Oxygen is inhaled for 30 minutes during migraine attack	Room Air n=31 Migraine attacks Medical air inhaled for 30 minutes during migraine attack Room air: Placebo
Final Nausea Score 0-1 on the Visual Analog Scale (VAS)	64 percentage of attacks	65 percentage of attacks

OTHER_PRE_SPECIFIED outcome

Timeframe: 60 minutes

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.

Outcome measures

Outcome measures
Measure	Oxygen n=33 Migraine attacks Oxygen is inhaled for 30 minutes during migraine attack Oxygen: Oxygen is inhaled for 30 minutes during migraine attack	Room Air n=31 Migraine attacks Medical air inhaled for 30 minutes during migraine attack Room air: Placebo
Post-gas Therapy Medication Use	36 percentage of attacks	52 percentage of attacks

Adverse Events

Oxygen

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Room Air

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Oxygen n=22 participants at risk Oxygen is inhaled for 30 minutes during migraine attack Oxygen: Oxygen is inhaled for 30 minutes during migraine attack	Room Air n=22 participants at risk Medical air inhaled for 30 minutes during migraine attack Room air: Placebo
General disorders Dry Mouth	4.5% 1/22 • Number of events 1 • 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. Specific adverse events ('events of interest') were monitored around the time of each migraine attack (individual subjects had 1-4 migraine attacks each).	0.00% 0/22 • 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. Specific adverse events ('events of interest') were monitored around the time of each migraine attack (individual subjects had 1-4 migraine attacks each).
Nervous system disorders Tingling	4.5% 1/22 • Number of events 1 • 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. Specific adverse events ('events of interest') were monitored around the time of each migraine attack (individual subjects had 1-4 migraine attacks each).	0.00% 0/22 • 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. Specific adverse events ('events of interest') were monitored around the time of each migraine attack (individual subjects had 1-4 migraine attacks each).
Nervous system disorders Significant worsening of migraine headache	0.00% 0/22 • 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. Specific adverse events ('events of interest') were monitored around the time of each migraine attack (individual subjects had 1-4 migraine attacks each).	9.1% 2/22 • Number of events 2 • 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. Specific adverse events ('events of interest') were monitored around the time of each migraine attack (individual subjects had 1-4 migraine attacks each).

Additional Information

Aneesh Singhal, MD

Massachusetts General Hospital

Phone: 6177268459

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place