Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 1679 for:    CARBON DIOXIDE AND dioxide

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02381795
Recruitment Status : Terminated (Terminated at the request of the financial sponsor.)
First Posted : March 6, 2015
Results First Posted : May 1, 2018
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
Capnia, Inc.
Information provided by (Responsible Party):
Cady, Roger, M.D.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cluster Headache
Intervention Drug: Nasal Carbon Dioxide
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nasal Carbon Dioxide
Hide Arm/Group Description

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

Period Title: Overall Study
Started 10
Completed 7
Not Completed 3
Reason Not Completed
Withdrawal by Subject             1
Study Terminated             2
Arm/Group Title Nasal Carbon Dioxide
Hide Arm/Group Description

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 Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
42.3  (13.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
3
  30.0%
Male
7
  70.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
10
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Headache Pain Intensity
Hide Description 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.
Time Frame Immediately preceeding treatment to 30 minutes post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nasal Carbon Dioxide
Hide Arm/Group Description:

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 Number of Participants Analyzed 9
Overall Number of Units Analyzed
Type of Units Analyzed: Cluster Headaches
23
Mean (Full Range)
Unit of Measure: units on a scale
-0.826
(-3 to 1)
Time Frame 25 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nasal Carbon Dioxide
Hide Arm/Group Description

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

All-Cause Mortality
Nasal Carbon Dioxide
Affected / at Risk (%)
Total   0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Nasal Carbon Dioxide
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nasal Carbon Dioxide
Affected / at Risk (%) # Events
Total   5/10 (50.00%)    
Endocrine disorders   
Goitre * 1  1/10 (10.00%)  1
Eye disorders   
Lacrimation increase * 1  2/10 (20.00%)  4
Gastrointestinal disorders   
Vomiting * 1  1/10 (10.00%)  1
Nervous system disorders   
Cluster headache * 1  1/10 (10.00%)  1
Headache * 1  1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
Nasal discomfort * 1  2/10 (20.00%)  4
Oropharyngeal pain * 1  1/10 (10.00%)  3
Sneezing * 1  1/10 (10.00%)  1
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Data Manager
Organization: Clinvest Research
Phone: 417-883-7889
EMail: jsly@clinvest.com
Layout table for additonal information
Responsible Party: Cady, Roger, M.D.
ClinicalTrials.gov Identifier: NCT02381795     History of Changes
Other Study ID Numbers: 15-001CA
First Submitted: March 3, 2015
First Posted: March 6, 2015
Results First Submitted: March 28, 2018
Results First Posted: May 1, 2018
Last Update Posted: August 14, 2018