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Trial record 3 of 5 for:    gammacore + prevention of migraine

Non-Invasive Neurostimulation for the Prevention of Chronic 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: NCT01667250
Recruitment Status : Completed
First Posted : August 17, 2012
Results First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
ElectroCore INC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Chronic Migraine
Interventions Device: GammaCore Active Device
Device: GammaCore Sham Device
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GammaCore Active Device GammaCore Sham Device No Treatment (run-in, Enrollment Period)
Hide Arm/Group Description

Subjects will use an Active GammaCore Device

GammaCore Active Device

Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study. The run-in period was 1 month, Subject who did not fulfill the inclusion and/or exclusion criteria was not randomized to the treatment groups
Period Title: Run-in (no Treatment)
Started 0 0 73
Completed 0 0 59
Not Completed 0 0 14
Period Title: Randomised Period
Started 30 29 0
Completed 29 28 0
Not Completed 1 1 0
Arm/Group Title GammaCore Active Device GammaCore Sham Device Total
Hide Arm/Group Description

Subjects will use an Active GammaCore Device

GammaCore Active Device

Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study. Total of all reporting groups
Overall Number of Baseline Participants 30 29 59
Hide Baseline Analysis Population Description
Randomized population
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants 29 participants 59 participants
39.7
(18.2 to 65.2)
41.0
(20.0 to 60.9)
40
(18.2 to 65.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 29 participants 59 participants
Female
26
  86.7%
27
  93.1%
53
  89.8%
Male
4
  13.3%
2
   6.9%
6
  10.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 29 participants 59 participants
White
26
  86.7%
25
  86.2%
51
  86.4%
Black
3
  10.0%
0
   0.0%
3
   5.1%
Hispanic
1
   3.3%
2
   6.9%
3
   5.1%
Other
0
   0.0%
1
   3.4%
1
   1.7%
Asian
0
   0.0%
1
   3.4%
1
   1.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants 29 participants 59 participants
30
 100.0%
29
 100.0%
59
 100.0%
1.Primary Outcome
Title Safety - Number of Participants With Adverse Events
Hide Description Safety was assessed by collecting Adverse Effects
Time Frame Up to 8 weeks - duration of the Randomized period
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized population
Arm/Group Title GammaCore Active Device GammaCore Sham Device
Hide Arm/Group Description:

Subjects will use an Active GammaCore Device

GammaCore Active Device

Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
Overall Number of Participants Analyzed 30 29
Measure Type: Count of Participants
Unit of Measure: Participants
6
  20.0%
5
  17.2%
2.Secondary Outcome
Title Mean Change in Headache Days
Hide Description Mean change in headache days. Change between 4 week run in period to the 8 weeks randomized period.
Time Frame Run-in period (4 weeks no treatment) and Randomized period (8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Data missing for 1 subject in each treatment group
Arm/Group Title GammaCore Active Device GammaCore Sham Device
Hide Arm/Group Description:

Subjects will use an Active GammaCore Device

GammaCore Active Device

Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: days
-1.5  (5.92) -0.2  (3.52)
3.Secondary Outcome
Title Total Number of Headache Days Per Arm With Peak Severity of Mild, Moderate, or Severe
Hide Description Peak severity per headache day was reported each headache day in the subject diary. Pain was reported as mild, moderate or severe. Whereas as mild = least severe and severe = most severe.
Time Frame Run-in (4 weeks no treatment) and Randomized (8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized population
Arm/Group Title GammaCore Active Device GammaCore Sham Device
Hide Arm/Group Description:

Subjects will use an Active GammaCore Device

GammaCore Active Device

Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
Overall Number of Participants Analyzed 30 29
Measure Type: Number
Unit of Measure: Headache days
Run-in Mild 167 131
Run-in Moderate 297 330
Run-in Severe 190 225
Randomized Mild 297 250
Randomized Moderate 443 511
Randomized Severe 274 395
4.Secondary Outcome
Title Use of Pain Relief Medication
Hide Description All abortive headache medication taken during randomized period
Time Frame Randomized period - 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized population
Arm/Group Title GammaCore Active Device GammaCore Sham Device
Hide Arm/Group Description:
Subjects will use an Active GammaCore Device GammaCore Active Device
Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
Overall Number of Participants Analyzed 30 29
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects taking abortive medication
26
  86.7%
25
  86.2%
Subjects taking no abortive medication
3
  10.0%
3
  10.3%
Subjects with no data
1
   3.3%
1
   3.4%
5.Secondary Outcome
Title Mean Change in Quality of Life Short Form Survey (SF-12)
Hide Description

The Quality of Life Short Form Survey (SF-12) is a multipurpose short form survey with 12 questions that are combined, scored and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of the twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

SF-12 were recorded in the subject diary at the Phase 1 follow-up visit (week 4) and during Phase 2 randomized period at week 4 and week 8.

Time Frame Run-in (4 weeks) and Randomized period (8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized period
Arm/Group Title GammaCore Active Device GammaCore Sham Device
Hide Arm/Group Description:

Subjects will use an Active GammaCore Device

GammaCore Active Device

Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Run-in PCS score 40.9  (9.62) 35.6  (10.46)
Randomized period PCS score 4 weeks 44.0  (9.25) 37.5  (12.73)
Randomized period PCS scores 8 weeks 45.3  (8.01) 38.0  (10.67)
Run-in MCS scores 44.5  (11.41) 45.8  (10.55)
Randomized period MCS scores 4 weeks 44.7  (10.53) 45.8  (11.71)
Randomized period MCS scores 8 weeks 46.5  (9.95) 44.3  (12.24)
Time Frame Up to 8 weeks - duration of the Randomized period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GammaCore Active Device GammaCore Sham Device
Hide Arm/Group Description

Subjects will use an Active GammaCore Device

GammaCore Active Device

Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study.
All-Cause Mortality
GammaCore Active Device GammaCore Sham Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/29 (0.00%)    
Hide Serious Adverse Events
GammaCore Active Device GammaCore Sham Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/30 (6.67%)      0/29 (0.00%)    
Gastrointestinal disorders     
Appendicitis * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
Nervous system disorders     
Worsening of Headache Pain * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GammaCore Active Device GammaCore Sham Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/30 (20.00%)      5/29 (17.24%)    
Ear and labyrinth disorders     
Intermittent Vertigo * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
Gastrointestinal disorders     
Nausea * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
Infections and infestations     
General malaise * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
Sore throat * 1  0/30 (0.00%)  0 1/29 (3.45%)  2
Musculoskeletal and connective tissue disorders     
Mild pains in head and right arm * 1 [1]  1/30 (3.33%)  1 0/29 (0.00%)  0
Nervous system disorders     
Altered sensations (brain zaps) * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
Migratory Paresthesia * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
Right arm (hand) tremor * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
Right eye twitching * 1  2/30 (6.67%)  2 0/29 (0.00%)  0
Lip twiching * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
Exacerbated migraine * 1  1/30 (3.33%)  1 2/29 (6.90%)  2
Lip numbness * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
Atypical migraine pain with associated blackouts * 1  0/30 (0.00%)  0 1/29 (3.45%)  1
Worsening of migraine * 1 [1]  1/30 (3.33%)  1 0/29 (0.00%)  0
Severe migraine * 1 [1]  1/30 (3.33%)  1 0/29 (0.00%)  0
Renal and urinary disorders     
Urinary incontinence * 1  0/30 (0.00%)  0 1/29 (3.45%)  1
Respiratory, thoracic and mediastinal disorders     
Hoarseness * 1  0/30 (0.00%)  0 1/29 (3.45%)  1
Skin and subcutaneous tissue disorders     
Blister at treatment site * 1  1/30 (3.33%)  1 0/29 (0.00%)  0
Rash at treatment site * 1  0/30 (0.00%)  0 1/29 (3.45%)  1
Itching * 1 [1]  1/30 (3.33%)  1 0/29 (0.00%)  0
Blisters at treatment site * 1 [1]  1/30 (3.33%)  1 0/29 (0.00%)  0
Rash/Blister at treatment site * 1 [1]  1/30 (3.33%)  1 0/29 (0.00%)  0
Redness at treatment site * 1 [1]  1/30 (3.33%)  1 0/29 (0.00%)  0
Rash * 1 [1]  1/30 (3.33%)  1 0/29 (0.00%)  0
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
[1]
Open label - phase 3
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 LLC
Phone: +1 973 355 6683
EMail: clinical@electrocorellc.com
Layout table for additonal information
Responsible Party: ElectroCore INC
ClinicalTrials.gov Identifier: NCT01667250    
Other Study ID Numbers: M-US-02
First Submitted: August 15, 2012
First Posted: August 17, 2012
Results First Submitted: March 8, 2018
Results First Posted: June 20, 2018
Last Update Posted: June 20, 2018