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NCT02381795 · ClinicalTrials.gov registry record · Phase 2
Pilot Study Evaluating the Use of Nasal Carbon Dioxide for the Treatment of Cluster Headache
A Phase 2 study, sponsored by Cady, Roger, M.D..
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT02381795 is a Phase 2 study that was terminated before completion, run by Cady, Roger, M.D.. The registered enrollment target is 10 participants.
The verdict
NCT02381795, a Phase 2 study, was terminated before completion, sponsored by Cady, Roger, M.D..
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study 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. 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
Interventions
- DRUG Nasal Carbon Dioxide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-07 |
| Est. Completion | 2017-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02381795
The ClinicalTrials.gov registry entry for NCT02381795 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cady, Roger, M.D., which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nasal Carbon Dioxide is the first listed.
NCT02381795 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02381795 about?
NCT02381795 is a clinical study titled "Pilot Study Evaluating the Use of Nasal Carbon Dioxide for the Treatment of 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...
What is the current status of trial NCT02381795?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2015-07. Estimated completion is 2017-04.
What interventions are being tested in trial NCT02381795?
The interventions under investigation include: Nasal Carbon Dioxide (DRUG).
Who is sponsoring clinical trial NCT02381795?
This trial is sponsored by Cady, Roger, M.D., which has 12 total clinical trials registered on ClinicalTrials.gov.
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