MigrainePhase 2NCT01542307

Normobaric Oxygen (NBO) Therapy in Acute Migraine

A Phase 2 study testing Oxygen and Room air in people with Migraine, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in acute migraine headache. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Migraine
What is being tested?: Oxygen and Room air
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteUnited States
Study dates: Jul 2012to Sep 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult subjects with frequent migraine (at least 1 attack per month)

Who cannot join

Secondary (non-migraine) headache
Chronic obstructive pulmonary disease
Pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in acute migraine headache.

Read the detailed description

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.

Conditions: Migraine
Being tested: Oxygen, Room air
Keywords: migraine, oxygen therapy
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxygenBiological
Oxygen is inhaled for 30 minutes during migraine attack
Room airBiological
Placebo

Study groups in NCT01542307
Study group	Role	What they receive
Oxygen	Experimental	Oxygen is inhaled for 30 minutes during migraine attack Receives: Biological: Oxygen
Room Air	Placebo comparator	Medical air inhaled for 30 minutes during migraine attack Receives: Biological: Room air

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From baseline (0 minutes) to 30 mins

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 60 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Sep 2015

First posted2 Mar 2012 (estimated)
Study startJul 2012
Primary completionSep 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MigraineStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01542307
Sponsor's protocol ID: 2009P000380
Other IDs: 2009P000380
Status last verified: Feb 2017
First submitted: 21 Feb 2012
Last updated: 27 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Singhal AB, Maas MB, Goldstein JN, Mills BB, Chen DW, Ayata C, Kacmarek RM, Topcuoglu MA. High-flow oxygen therapy for treatment of acute migraine: A randomized crossover trial. Cephalalgia. 2017 Jul;37(8):730-736. doi: 10.1177/0333102416651453. Epub 2016 May 20.
PubMed 27206964

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Normobaric Oxygen (NBO) Therapy in Acute Migraine
ClinicalTrials.gov ID: NCT01542307
Acronym / sponsor ID: 2009P000380
Conditions: Migraine
Keywords: migraine, oxygen therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: Jul 2012
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 2 Mar 2012 (estimated)
Results: Posted 27 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in acute migraine headache.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Oxygen	Experimental	Biological: OxygenOxygen is inhaled for 30 minutes during migraine attack
Room Air	Placebo comparator	Biological: Room airMedical air inhaled for 30 minutes during migraine attack

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult subjects with frequent migraine (at least 1 attack per month)

Key exclusion criteria (3 listed)

Secondary (non-migraine) headache
Chronic obstructive pulmonary disease
Pregnant

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OxygenOxygen is inhaled for 30 minutes during migraine attack	Biological	Oxygen
Room airPlacebo	Biological	Room Air

Primary outcome

Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS)
Time frame: From baseline (0 minutes) to 30 mins
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.

6 secondary outcomes

Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS)
Time frame: Baseline (0 minutes) to 15 minutes
Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS)
Time frame: Baseline (0 minutes) to 60 minutes
Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS)
Time frame: 60 minutes
Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS)
Time frame: 60 minutes
Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS)
Time frame: 60 minutes
Final Nausea Score 0-1 on the Visual Analog Scale (VAS)
Time frame: 60 minutes

Results and safety

Results posted to the registry on 27 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxygen-treated Migraine Attacks	22	22
Medical Air-treated Migraine Attacks	22	22

Primary outcome: Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS)

Time frame: From baseline (0 minutes) to 30 mins. Mean (Standard Deviation). Unit: units on a scale

Measure	Oxygen n = 22	Room Air n = 22
Value	1.38 (1.42)	1.22 (1.61)

Oxygen vs Room Air: p = 0.674, Wilcoxon (Mann-Whitney)

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

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxygen	0 of 22 (0%)	2 of 22 (9.1%)	Not reported
Room Air	0 of 22 (0%)	2 of 22 (9.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27206964Singhal AB, Maas MB, Goldstein JN, Mills BB, Chen DW, Ayata C, Kacmarek RM, Topcuoglu MA. High-flow oxygen therapy for treatment of acute migraine: A randomized crossover trial. Cephalalgia. 2017 Jul;37(8):730-736. doi: 10.1177/0333102416651453. Epub 2016 May 20.
Individual participant dataSharing planned: Undecided

Related trials for Migraine

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aneesh B Singhal, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxygen and Room air in people with Migraine, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS) (time frame: From baseline (0 minutes) to 30 mins). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01542307, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.