MigrainePhase 2NCT00690716
The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Mild Headache in People Who Experience Migraines
A Phase 2 study testing Nasal CO2 in people with Migraine, run by Capnia, Inc. at 15 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the treatment of mild headaches in people who have migraines. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Nasal CO2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 292 participants
- Where
- 15 sitesUnited States
- Study dates
- Aug 2008to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to read and understand informed consent form and voluntarily consent to participate in this study by signing the IRB-approved informed consent form
- Established diagnosis of migraine with or without aura per ICHD-II (patients with a diagnosis of only menstrual migraine are not eligible)
- History of 2-8 migraine attacks per month during the 3 months prior to randomization
- Have a typical migraine which progresses from a distinct mild headache to a moderate or severe migraine
- Able to recognize a mild headache that could develop into a moderate or severe migraine
Who cannot join
- Have less than 48 hours of freedom from headache between attacks of migraine
- Have 15 or more headache days per month
- Are females who are pregnant or lactating
- Use antipsychotic or antidepressant medications (unless only for migraine prophylaxis) within 12 weeks prior to randomization and for the duration of the study
- Have a concurrent diagnosis of TMD or trigeminal neuralgia requiring treatment
- Clinically significant deviated septum, nasal polyps or other nasal condition that prevents unrestricted breathing through each nostril
- Have participated in another study with nasal CO2
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Capnia Investigative Site
Ann Arbor, Michigan, 48104
Capnia Investigative Site
Birmingham, Alabama, 35233
Capnia Investigative Site
Chicago, Illinois, 60647
Capnia Investigative Site
East Hartford, Connecticut, 06118
Capnia Investigative Site
Kalamazoo, Michigan, 49009
Capnia Investigative Site
Nashville, Tennessee, 37203
Capnia Investigative Site
North Dartmouth, Massachusetts, 02747
Capnia Investigative Site
Philadelphia, Pennsylvania, 19107
Capnia Investigative Site
Pittsburgh, Pennsylvania, 15213
Capnia Investigative Site
Seattle, Washington, 98104
Capnia Investigative Site
Springfield, Missouri, 65807
Capnia Investigative Site
St Louis, Missouri, 63141
Capnia Investigative Site
Stanford, California, 94305
Capnia Investigative Site
Wellesley Hills, Massachusetts, 02481
Capnia Investigative Site
West Palm Beach, Florida, 33407
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Nasal Carbon Dioxide in the Treatment of Mild Headache in Migraineurs
The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the treatment of mild headaches in people who have migraines.
Read the detailed description
This multi-center, adaptively randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of a nasal, non-inhaled administration of carbon dioxide (CO2) in the treatment of mild headaches. An estimated 250 patients who meet the eligibility criteria will be enrolled into this study at approximately 15 sites to ensure that about 220 patients are randomized and complete the study.
- Conditions
- Migraine
- Being tested
- Nasal CO2, Inactive Placebo
- Keywords
- Nasal CO2, Phase II, Adaptive, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Multi-center, Safety, Efficacy, Mild Headache, Migraineur
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal CO2Drug
Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache
Inactive PlaceboDrug
Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nasal CO2 Receives: Drug: Nasal CO2 |
| 2 | Placebo comparator | Inactive Placebo Receives: Drug: Inactive Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who are pain-free
Measured: 2 hours post study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capnia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger K. Cady, MD, Study chair, Clinvest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690716
- Sponsor's protocol ID
- C112
- Status last verified
- Aug 2012
- First submitted
- 3 Jun 2008
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Nasal Carbon Dioxide in the Treatment of Mild Headache in Migraineurs
- ClinicalTrials.gov ID
- NCT00690716
- Acronym / sponsor ID
- C112
- Conditions
- Migraine
- Keywords
- Nasal CO2, Phase II, Adaptive, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Multi-center
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Capnia, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the treatment of mild headaches in people who have migraines.
Detailed description
This multi-center, adaptively randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of a nasal, non-inhaled administration of carbon dioxide (CO2) in the treatment of mild headaches. An estimated 250 patients who meet the eligibility criteria will be enrolled into this study at approximately 15 sites to ensure that about 220 patients are randomized and complete the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Nasal CO2Nasal CO2 |
| 2 | Placebo comparator | Drug: Inactive PlaceboInactive Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to read and understand informed consent form and voluntarily consent to participate in this study by signing the IRB-approved informed consent form
- Established diagnosis of migraine with or without aura per ICHD-II (patients with a diagnosis of only menstrual migraine are not eligible)
- History of 2-8 migraine attacks per month during the 3 months prior to randomization
- Have a typical migraine which progresses from a distinct mild headache to a moderate or severe migraine
- Able to recognize a mild headache that could develop into a moderate or severe migraine
Key exclusion criteria (7 listed)
- Have less than 48 hours of freedom from headache between attacks of migraine
- Have 15 or more headache days per month
- Are females who are pregnant or lactating
- Use antipsychotic or antidepressant medications (unless only for migraine prophylaxis) within 12 weeks prior to randomization and for the duration of the study
- Have a concurrent diagnosis of TMD or trigeminal neuralgia requiring treatment
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 |
|---|---|---|
| Nasal CO2Adaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache | Drug | 1 |
| Inactive PlaceboAdaptive Randomization to a Dosing Regimen for Treatment of a Qualifying Headache | Drug | 2 |
Primary outcome
The proportion of patients who are pain-free
Time frame: 2 hours post study drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
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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.
Roger K. Cady, MD study chair
Clinvest
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nasal CO2 in people with Migraine, run by Capnia, Inc. at 15 sites 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 5 inclusion and 7 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 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of patients who are pain-free (time frame: 2 hours post study drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2012.