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Completed

NCT Number: NCT01542307

Normobaric Oxygen (NBO) Therapy in Acute Migraine

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

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Oxygen

Biological

Oxygen is inhaled for 30 minutes during migraine attack

Room air

Biological

Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS)

    Time frame: 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.

  2. Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS)

    Time frame: 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.

  3. Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS)

    Time frame: 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.

  4. Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS)

    Time frame: 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.

  5. Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS)

    Time frame: 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.

  6. Final Nausea Score 0-1 on the Visual Analog Scale (VAS)

    Time frame: 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.

Other outcomes

  1. Post-gas Therapy Medication Use

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 2, 2012
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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