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Non-invasive Neurostimulation for the Relief of Migraine

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: NCT03410628
Recruitment Status : Terminated (Company decision)
First Posted : January 25, 2018
Results First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
ElectroCore INC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Migraine
Intervention Device: gammaCore
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title gammaCore Active Device
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open label

gammaCore: Non-invasive vagal nerve stimulator

Period Title: Overall Study
Started 21
Completed 15
Not Completed 6
Arm/Group Title gammaCore Active Device
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open label

gammaCore: Non-invasive vagal nerve stimulator

Overall Number of Baseline Participants 21
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Safety population
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants
38.6
(22 to 55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
20
  95.2%
Male
1
   4.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
White
17
  81.0%
Asian
2
   9.5%
Other
1
   4.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
South Africa Number Analyzed 21 participants
21
1.Primary Outcome
Title Safety - Number of Participants With Adverse Events
Hide Description Safety was assessed by collecting adverse events for the duration of the study
Time Frame Up to 4 months
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safety population
Arm/Group Title gammaCore Active Device
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open label

gammaCore: Non-invasive vagal nerve stimulator

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.8%
2.Secondary Outcome
Title Change in Headache Pain Severity From Baseline to 120 Minutes for First Treated Migraine Attack
Hide Description At the onset of headache pain subjects self-administered treatment with the study device and completed headache pain scores using a 4 point scale (where 3 = severe, 2 = moderate, 1 = mild and 0 = no pain) at baseline (0 minutes) and 120 minutes.
Time Frame 120 minutes
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Hide Analysis Population Description
Safety population, 6 subjects had missing data
Arm/Group Title gammaCore Active Device
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open label

gammaCore: Non-invasive vagal nerve stimulator

Overall Number of Participants Analyzed 15
Mean (Full Range)
Unit of Measure: units on a scale
Headache pain severity at Baseline
2.2
(1 to 3)
Headache pain severity at 120 minutes
1.2
(0 to 3)
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title gammaCore Active Device
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open label

gammaCore: Non-invasive vagal nerve stimulator

All-Cause Mortality
gammaCore Active Device
Affected / at Risk (%)
Total   0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
gammaCore Active Device
Affected / at Risk (%) # Events
Total   0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
gammaCore Active Device
Affected / at Risk (%) # Events
Total   1/21 (4.76%)    
Gastrointestinal disorders   
Diarrhea * 1  1/21 (4.76%)  2
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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 Affairs
Organization: electroCore Inc.
Phone: +1 973 355 6683
EMail: clinical@electrocorellc.com
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Responsible Party: ElectroCore INC
ClinicalTrials.gov Identifier: NCT03410628     History of Changes
Other Study ID Numbers: M-SA-01
First Submitted: March 12, 2015
First Posted: January 25, 2018
Results First Submitted: July 2, 2018
Results First Posted: July 25, 2018
Last Update Posted: July 25, 2018