Trial Outcomes & Findings for Pilot Study Evaluating the Use of Nasal Carbon Dioxide for the Treatment of Cluster Headache (NCT NCT02381795)
NCT ID: NCT02381795
Last Updated: 2018-08-14
Results Overview
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.
TERMINATED
PHASE2
10 participants
Immediately preceeding treatment to 30 minutes post-treatment
2018-08-14
Participant Flow
Participant milestones
| Measure |
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).
Nasal Carbon Dioxide
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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).
Nasal Carbon Dioxide
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Study Terminated
|
2
|
Baseline Characteristics
Pilot Study Evaluating the Use of Nasal Carbon Dioxide for the Treatment of Cluster Headache
Baseline characteristics by cohort
| Measure |
Nasal Carbon Dioxide
n=10 Participants
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).
Nasal Carbon Dioxide
|
|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 13.58 • n=39 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Immediately preceeding treatment to 30 minutes post-treatmentPopulation: Enrolled subjects reporting at least one headache during study period. One enrolled subject did not experience any headaches during the study period and thus was not included in the analysis.
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.
Outcome measures
| Measure |
Nasal Carbon Dioxide
n=23 Cluster Headaches
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).
Nasal Carbon Dioxide
|
|---|---|
|
Headache Pain Intensity
|
-0.826 units on a scale
Interval -3.0 to 1.0
|
Adverse Events
Nasal Carbon Dioxide
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nasal Carbon Dioxide
n=10 participants at risk
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).
Nasal Carbon Dioxide
|
|---|---|
|
Nervous system disorders
Cluster headache
|
10.0%
1/10 • Number of events 1 • 25 weeks
|
|
Endocrine disorders
Goitre
|
10.0%
1/10 • Number of events 1 • 25 weeks
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • 25 weeks
|
|
Eye disorders
Lacrimation increase
|
20.0%
2/10 • Number of events 4 • 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
20.0%
2/10 • Number of events 4 • 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • Number of events 3 • 25 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
10.0%
1/10 • Number of events 1 • 25 weeks
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • 25 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place