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Cluster HeadachePhase 2NCT02381795

Pilot Study Evaluating the Use of Nasal Carbon Dioxide for the Treatment of Cluster Headache

A Phase 2 study testing Nasal Carbon Dioxide in people with Cluster Headache, run by Cady, Roger, M.D. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open label, investigator-sponsored, pilot study. Subjects agreeing to participate in the study and meeting the eligibility criteria assessed at the screening visit will be enrolled in the study. The length of time between screening and treatment will last between 0 days to a maximum of 12 weeks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cluster Headache
What is being tested?
Nasal Carbon Dioxide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Jul 2015to Apr 2017
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

  • Male and female, 18 years of age and older.
  • History of episodic cluster headache, as defined by International Classification of Headache Disorders (ICHD), third edition, beta version guidelines (ICHD-3 beta, Cephalalgia 2013).
  • History of cluster headache attack-free remission periods lasting > 1 month within the previous year.
  • Stable on medications, including those for the treatment of cluster headache prevention/prophylaxis, for at least 60 days prior to baseline (including, but not limited to, verapamil, lithium, melatonin, any anticonvulsant, any systemic corticosteroid or steroid injection, occipital nerve block, other cranial or extracranial nerve block, or any neurostimulation treatment).
  • Note: Subjects are allowed to use their usual standard of care for the acute/abortive treatment of acute cluster attacks 60 or more minutes after the initial dose, limited to the following: triptans; high-flow oxygen.
  • If female and of childbearing potential, have a negative urine pregnancy test at the time of Screening.
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  • To not be considered childbearing potential a subject must be surgically sterile, have had a hysterectomy or tubal ligation, post-menopausal for at least 1 year, or otherwise incapable of pregnancy.
  • Capable of completing online headache diary with access to internet.
  • Able to provide written Informed Consent.

Who cannot join

  • Recent nasal/midface trauma (< 3 months)
  • Recent nasal/sinus surgery (< 3 months).
  • Severe respiratory distress in the last 6 months.
  • Neoplasm such as Angiofibroma, sinus tumor, granuloma.
  • Nasal congestion present more than 10 days with fever (temperature ≥ 100.4 °F) and nasal mucous is an abnormal color.
  • Surgery to treat cluster headache.
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  • History of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
  • Structural intracranial or cervical vascular lesions that may potentially cause headache attacks.
  • Other significant pain problems (including cancer pain, fibromyalgia, and trigeminal neuralgia) that might confound the study assessments in the investigator opinion.
  • Psychiatric disorder, which in the opinion of the Investigator, may interfere with the study.
  • Pregnant, actively trying to become pregnant, or breastfeeding, and/or is unwilling to use an accepted form of birth control.
  • Skin around and inside the nasal passage that is dry, cracked, oozing, or bleeding.
  • Recurrent nose bleeds, which in the opinion of the Investigator, may interfere with the study.
  • Is participating in any other therapeutic clinical investigation or has participated in a clinical trial and received treatment in the preceding 30 days.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinvest/A Division of Banyan Group, Inc.

    Springfield, Missouri, 65807

Other trials in United States

About this study

Official title: An Open Label, Pilot Study Evaluating the Efficacy and Safety of the Use of Nasal Carbon Dioxide for the Treatment of Episodic Cluster Headache

This is an open label, investigator-sponsored, pilot study. Subjects agreeing to participate in the study and meeting the eligibility criteria assessed at the screening visit will be enrolled in the study. The length of time between screening and treatment will last between 0 days to a maximum of 12 weeks. Subjects who enter the screening phase during a cluster headache episode and meet the study eligibility criteria can immediately enter the treatment phase and may opt to treat their cluster headache episode in the clinic. Subjects who are not in a cluster headache episode, who meet initial screening eligibility criteria, can remain in the screening phase for up to 12 weeks until their next cluster episode begins. Upon initiation of a cluster headache episode, subjects will enter the treatment period. Subjects will be trained on the proper use of the hand-held dispenser containing carbon dioxide (CO2 )calibrated to deliver 0.5 standard liters per minute (SLPM). This dispenser will be provided for use in the clinic or home. Subjects will be instructed to use the nasal CO2 dispenser, 10 seconds/nostril, as needed up to 6 times to treat one attack. Each dose must be separated by 3-5 minutes. Subjects should treat only one attack in a 24-hour period. Subjects may treat up to three cluster headache attacks during the treatment phase of this study. One hour after the first dose, subjects can choose to treat with investigator-approved rescue medication. Subjects will be asked to complete an online diary after the completion of the dosing. Diary assessments will collect pain severity, nasal CO2 usage, acute medication usage, satisfaction of treatment, number of cluster attacks, and unusual symptoms. Subjects will be contacted by phone within 3 days of the first use of the nasal CO2 dispenser to assess adverse events (AEs) and medication usage. A total of 25 subjects will enter the treatment period and be instructed to treat up to 3 cluster headaches with nasal CO2. Within 7 days of treating their last cluster headache episode, subjects will return for an end of study visit.

Being tested
Nasal Carbon Dioxide
Medical subject headings
Cluster Headache

What participants receive

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

  • Nasal Carbon DioxideDrug

Study groups in NCT02381795
Study groupRoleWhat they receive
Nasal Carbon DioxideExperimental0.17 liters (L) of carbon dioxide (CO2) will be delivered through two 10 second administrations in each nostril, up to 6 times, to treat one attack (total of 1.0 L CO2). Subjects may treat up to three cluster headache attacks during the treatment phase of this study (total of 3.0 L (CO2).
Receives: Drug: Nasal Carbon Dioxide

What is being measured

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

  1. Headache Pain Intensity

    Greatest change in headache pain intensity post treatment (at any time point within 30 minutes of Nasal CO2 administration) - pre-treatment. Pain intensity will be measured as follows: 0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain. Full Range values were calculated change values, and do not represent the full range of the scale.

    Measured: Immediately preceeding treatment to 30 minutes post-treatment

Timeline

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

  1. First posted6 Mar 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionApr 2017
  4. Study completionApr 2017

Why it stopped: Terminated at the request of the financial sponsor.

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02381795
Sponsor's protocol ID
15-001CA
Status last verified
Jul 2018
First submitted
3 Mar 2015
Last updated
14 Aug 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nasal Carbon Dioxide in people with Cluster Headache, run by Cady, Roger, M.D. 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 9 inclusion and 14 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 14 Aug 2018. 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. 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 1 May 2018). 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?

Headache Pain Intensity (time frame: Immediately preceeding treatment to 30 minutes post-treatment). 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 NCT02381795.

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 14 Aug 2018.

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