- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02381795
Pilot Study Evaluating the Use of Nasal Carbon Dioxide for the Treatment of Cluster Headache
An Open Label, Pilot Study Evaluating the Efficacy and Safety of the Use of Nasal Carbon Dioxide for the Treatment of Episodic Cluster Headache
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Missouri
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Springfield, Missouri, United States, 65807
- Clinvest/A Division of Banyan Group, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
a. 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Nasal Carbon Dioxide
0.17 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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Headache Pain Intensity
Time Frame: Immediately preceeding treatment to 30 minutes post-treatment
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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.
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Immediately preceeding treatment to 30 minutes post-treatment
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-001CA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cluster Headache
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Eli Lilly and CompanyCompletedEpisodic Cluster Headache | Chronic Cluster HeadacheSpain, United States, Finland, Germany, United Kingdom, Belgium, France, Denmark, Italy, Netherlands, Canada, Greece
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Winston LaboratoriesNot yet recruitingEpisodic Cluster Headache
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Man and Science, SARecruitingChronic Cluster HeadacheBelgium
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Radboud University Medical CenterLeiden University Medical Center; ZonMw: The Netherlands Organisation for Health... and other collaboratorsNot yet recruitingChronic Cluster Headache
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Leiden University Medical CenterUniversity of Copenhagen; Maastricht University Medical Center; Erasmus Medical... and other collaboratorsCompletedChronic Cluster HeadacheNetherlands, Belgium, Germany, Hungary
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Hospices Civils de LyonNot yet recruitingCluster Headache, Episodic
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H. Lundbeck A/SCompletedCluster Headache, EpisodicSpain, United States, Germany, Portugal, Italy, Netherlands, Finland, Belgium, Czechia, Denmark, France, Georgia, Russian Federation, United Kingdom, Greece, Estonia, Japan, Norway, Sweden
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Teva Branded Pharmaceutical Products R&D, Inc.TerminatedEpisodic Cluster HeadacheUnited States, Australia, Finland, Germany, Israel, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom, Canada
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Eli Lilly and CompanyCompletedEpisodic Cluster HeadacheItaly, United States, Canada, Belgium, Denmark, Finland, France, Germany, Spain, United Kingdom, Netherlands, Greece
Clinical Trials on Nasal Carbon Dioxide
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Capnia, Inc.CompletedTrigeminal NeuralgiaUnited States
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Capnia, Inc.CompletedPerennial Allergic RhinitisUnited States
-
Capnia, Inc.United States Naval Medical Center, San Diego; Walter Reed National Military... and other collaboratorsTerminatedMigraineUnited States
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Capnia, Inc.CompletedPain | Temporomandibular Disorders | HeadachesUnited States
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SMG-SNU Boramae Medical CenterUnknownVentilation Perfusion Mismatch
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Meshalkin Research Institute of Pathology of CirculationUnknownCarbon DioxideRussian Federation
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Rutgers, The State University of New JerseyCompleted
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Washington University School of MedicineRecruiting
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Imperial College LondonUnknown
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Imperial College LondonUnknownHeart Failure | Periodic BreathingUnited Kingdom