MigrainePhase 2NCT01253915
The Effect of Nasal Carbon Dioxide in the Treatment of Moderate to Severe Migraine
A Phase 2 study testing Nasal Carbon Dioxide in people with Migraine, run by Capnia, Inc. at 3 sites in United States.
Trial summary
This multi-center, double-blind, placebo-controlled, parallel group trial carbon dioxide in the treatment of moderate to severe migraine. At approximately 8 US sites, approximately 450 patients who meet the eligibility criteria will be randomized to active or placebo in a 1:1 ratio to ensure that 400 patients will… 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 Carbon Dioxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2012to Jun 2013
- 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
- Males and females ages 18 - 65 years
- Established diagnosis of migraine with or without aura per ICHD-II (patients with a diagnosis of only menstrual migraine are not eligible)
- At least a one-year history of migraine symptoms with or without aura
- Age at migraine onset less than 50 years
- History of 2-8 migraine attacks per month during the 3 months prior to randomization
- Females of childbearing potential must commit to using an acceptable method of birth control (e.g., oral birth control pills, intrauterine device (IUD), or a double-barrier method of contraception) through 7 days after last study drug administration. To be considered not of childbearing potential, females must be post-menopausal for at least 2 years or be surgically sterile
Who cannot join
- Have less than 48 hours of freedom from headache between attacks of migraine
- Have 15 or more headache days per month
- Have migraine secondary to traumatic brain injury (TBI)
- Are unable to comply with protocol requirements
- Females who are pregnant or breast-feeding and/or plan to become pregnant or to breast-feed during study participation or within 7 days after last study drug administration
- Have changed their usage of prescription migraine prophylaxis medications within 12 weeks prior to randomization
Show all 16Show fewer
- 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 history of alcohol or drug abuse within 2 years prior to randomization
- Have a psychiatric disease which may prevent patient compliance or otherwise interfere with the ability of the patient to participate in the study
- Have a medical condition that makes study participation unwise in the opinion of the Investigator (e.g., significant COPD, heart disease, etc.)
- Have a concurrent diagnosis of temporomandibular disorders (TMD) or trigeminal neuralgia requiring treatment
- Clinically significant deviated septum, nasal polyps or other nasal condition that prevents unrestricted breathing through each nostril
- Are going to travel extensively by airplane during the 56-day treatment period (e.g., anticipated travel by airplane more than 25% of the 56-day treatment period, 14 days)
- Have a member of the same household also participating in this study
- Use of any investigational or experimental therapy within 30 days of randomization
- Have participated in another study with nasal CO2
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Walter Reed National Military Medical Center - Dept of Neurology
Bethesda, Maryland, 20889
Naval Medical Center Portsmouth - Dept of Neurology
Portsmouth, Virginia, 23708
Naval Medical Center San Diego - Dept of Neurology
San Diego, California, 92134
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 Moderate to Severe Migraine
This multi-center, double-blind, placebo-controlled, parallel group trial carbon dioxide in the treatment of moderate to severe migraine. At approximately 8 US sites, approximately 450 patients who meet the eligibility criteria will be randomized to active or placebo in a 1:1 ratio to ensure that 400 patients will treat at least one moderate to severe migraine with the study drug.
Patients will be randomized to one of two treatment groups and be provided with either an active or placebo dispenser.
Read more
All patients will administer study drug for 10 seconds to each nostril when experiencing a qualifying headache. Patients will assess their pain and other migraine-related symptoms in a patient diary. If a patient still has pain and/or any other symptoms after the initial dose then the patient may opt to take 3 more doses to treat the headache.
Each patient's participation in the study may last up to 56 days or once the patient treats 4 headaches with the study drug, whichever occurs first.
There will be a total of 2 scheduled clinic visits:
- Visit 1 Screening/Randomization
- Visit 2 End of Study (within 7 days after the patients treats his/her fourth headache or after the end of the 56-day treatment period, whichever occurs first)
- Conditions
- Migraine
- Being tested
- Nasal Carbon Dioxide, Placebo
- 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 Carbon DioxideDrug
10 sec/nostril up to 4 times to treat one migraine
PlaceboDrug
10 sec/nostril up to 4 times to treat a migraine
| Study group | Role | What they receive |
|---|---|---|
| Carbon Dioxide | Experimental | Not described Receives: Drug: Nasal Carbon Dioxide |
| Placebo | Placebo comparator | Not described Receives: Drug: 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: at 2 hours after study drug administration
Secondary outcomes (3)
The proportion of patients who are nausea/vomiting free
Measured: at 2 hours after study drug administration
The proportion of patients who are phonophobia free
Measured: at 2 hours after study drug administration
The proportion of patients who are photophobia free
Measured: at 2 hours after 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 posted6 Dec 2010 (estimated)
- Study startJan 2012
- Primary completionApr 2013
- Study completionJun 2013
Why it stopped: Low enrollment and lack of funding for study
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capnia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Walter Reed National Military Medical Center, United States Naval Medical Center, San Diego, United States Naval Medical Center, Portsmouth, Madigan Army Medical Center
- Responsible party
- Sponsor
- Investigators
- Peter M Bertrand, DDS, Study chair, National Naval Medical Center, Bethesda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253915
- Sponsor's protocol ID
- C113
- Status last verified
- Oct 2013
- First submitted
- 2 Dec 2010
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. 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 Moderate to Severe Migraine
- ClinicalTrials.gov ID
- NCT01253915
- Acronym / sponsor ID
- C113
- Conditions
- Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment and lack of funding for study
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Capnia, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Walter Reed National Military Medical Center, United States Naval Medical Center, San Diego, United States Naval Medical Center, Portsmouth, Madigan Army Medical Center
- Study start
- Jan 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Dec 2010 (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.
This multi-center, double-blind, placebo-controlled, parallel group trial carbon dioxide in the treatment of moderate to severe migraine. At approximately 8 US sites, approximately 450 patients who meet the eligibility criteria will be randomized to active or placebo in a 1:1 ratio to ensure that 400 patients will treat at least one moderate to severe migraine with the study drug.
Patients will be randomized to one of two treatment groups and be provided with either an active or placebo dispenser.
All patients will administer study drug for 10 seconds to each nostril when experiencing a qualifying headache. Patients will assess their pain and other migraine-related symptoms in a patient diary. If a patient still has pain and/or any other symptoms after the initial dose then the patient may opt to take 3 more doses to treat the headache.
Each patient's participation in the study may last up to 56 days or once the patient treats 4 headaches with the study drug, whichever occurs first.
There will be a total of 2 scheduled clinic visits:
- Visit 1 Screening/Randomization
- Visit 2 End of Study (within 7 days after the patients treats his/her fourth headache or after the end of the 56-day treatment period, whichever occurs first)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbon Dioxide | Experimental | Drug: Nasal Carbon Dioxide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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
- Males and females ages 18 - 65 years
- Established diagnosis of migraine with or without aura per ICHD-II (patients with a diagnosis of only menstrual migraine are not eligible)
- At least a one-year history of migraine symptoms with or without aura
- Age at migraine onset less than 50 years
Key exclusion criteria (16 listed)
- Have less than 48 hours of freedom from headache between attacks of migraine
- Have 15 or more headache days per month
- Have migraine secondary to traumatic brain injury (TBI)
- Are unable to comply with protocol requirements
- Females who are pregnant or breast-feeding and/or plan to become pregnant or to breast-feed during study participation or within 7 days after last study drug administration
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 Carbon Dioxide10 sec/nostril up to 4 times to treat one migraine | Drug | Carbon Dioxide |
| Placebo10 sec/nostril up to 4 times to treat a migraine | Drug | Placebo |
Primary outcome
The proportion of patients who are pain-free
Time frame: at 2 hours after study drug administration
3 secondary outcomes
The proportion of patients who are nausea/vomiting free
Time frame: at 2 hours after study drug administration
The proportion of patients who are phonophobia free
Time frame: at 2 hours after study drug administration
The proportion of patients who are photophobia free
Time frame: at 2 hours after study drug administration
Results and safety
The study was stopped early (reason given: Low enrollment and lack of funding for study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
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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.
Peter M Bertrand, DDS study chair
National Naval Medical Center, Bethesda
3 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 Carbon Dioxide in people with Migraine, run by Capnia, Inc. at 3 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 7 inclusion and 16 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: stopped early, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was stopped early (reason given: Low enrollment and lack of funding for study). Results are not available in the source record.
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: at 2 hours after 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 31 Oct 2013.