Trial Outcomes & Findings for Non-Invasive Neurostimulation For the Relief of Symptoms Associated With Migraine (NCT NCT01532830)

NCT ID: NCT01532830

Last Updated: 2018-07-10

Results Overview

The primary outcome measure for this study was the assessment of adverse events as unanticipated or anticipated.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: End of Study - 7 weeks
• Results posted on: 2018-07-10

Participant Flow

Participant milestones

Measure	gammaCore Device non-invasive vagus nerve stimulator gammaCore: treatment with gammaCore vagus nerve stimulator
Overall Study STARTED	30
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Non-Invasive Neurostimulation For the Relief of Symptoms Associated With Migraine

Baseline characteristics by cohort

Measure	Active n=30 Participants n-VNS active therapy
Age, Continuous	38.5 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race/Ethnicity, Customized White	19 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: End of Study - 7 weeks

Population: Randomized population

The primary outcome measure for this study was the assessment of adverse events as unanticipated or anticipated.

Outcome measures

Measure	Active n=30 Participants n-VNS active therapy
Safety - Number of Participants With Adverse Effects Unanticipated Adverse Effects	0 Participants
Safety - Number of Participants With Adverse Effects Anticipated Adverse Effects	13 Participants

SECONDARY outcome

Timeframe: 120 minutes

Population: Randomized population. 2 subjects were excluded from the analysis due to protocol deviations

Headache was measured on a 4 point scale where 0 = no pain, 1 = mild, 2 = moderate, 3 = severe pain at baseline (start of attack), 5, 15, 30, 45, 60, 90 and 120 minutes.

Data presented shows the average change from baseline to 120 minutes

Outcome measures

Measure	Active n=28 Participants n-VNS active therapy
Mean Change in Headache Pain From Baseline to 120 Minutes Mean baseline pain score	1.84 units on a scale Interval 0.0 to 3.0
Mean Change in Headache Pain From Baseline to 120 Minutes Mean 120 minutes pain score	1.20 units on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: Base line and 120 minutes

Population: Randomized population. Data was missing for 3 patients

Presence of photophobia (yes or no) was captured at baseline and 120 minutes.

Outcome measures

Measure	Active n=27 Participants n-VNS active therapy
Change in Photophobia (Visual) From Baseline to 120 Minutes Migraine attacks with photophobia at baseline	53 migraines with photophobia
Change in Photophobia (Visual) From Baseline to 120 Minutes Migraine attacks with photophobia at 120 minutes	37 migraines with photophobia

SECONDARY outcome

Timeframe: Baseline and 120 minutes

Population: Randomized population. Data was missing for 3 patients

Presence of phonophobia (yes or no) was captured at baseline and 120 minutes.

Outcome measures

Measure	Active n=27 Participants n-VNS active therapy
Change in Phonophobia (Auditory) From Baseline to 120 Minutes Migraine attacks with phonophobia at 120 minutes	15 migraines with phonophobia
Change in Phonophobia (Auditory) From Baseline to 120 Minutes Migraine attacks with phonophobia at baseline	32 migraines with phonophobia

SECONDARY outcome

Timeframe: Baseline 120 minutes

Population: Randomized population. Data was missing for 3 patients

Nausea was captured in the diary and measured on a 4 point scale, where 0 = no nausea, 1 = mild, 2 = moderate and 3 = severe nausea, at baseline and 120 minutes.

Outcome measures

Measure	Active n=27 Participants n-VNS active therapy
Mean Change in Nausea From Baseline to 120 Minutes Nausea severity at baseline	0.42 units on a scale Interval 0.0 to 3.0
Mean Change in Nausea From Baseline to 120 Minutes Nausea severity at 120 minutes	0.34 units on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: Baseline and 120 minutes

Population: Randomized population. Data was missing for 3 patients

Functional disability was captured in the diary and measured on a 4 point scale, where 0 = no disability, able to function normally and where 3 = performance of daily activities severely impaired, measured at baseline and 120 minutes.

Outcome measures

Measure	Active n=27 Participants n-VNS active therapy
Mean Change in Functional Disability Mean disability score at baseline	1.07 units on a scale Interval 0.0 to 3.0
Mean Change in Functional Disability Mean disability score at 120 minutes	0.77 units on a scale Interval 0.0 to 3.0

Adverse Events

Active

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active n=30 participants at risk n-VNS active therapy
Musculoskeletal and connective tissue disorders Stiff Neck	6.7% 2/30 • Number of events 4 • 7 weeks
Infections and infestations Viral Infection	3.3% 1/30 • Number of events 1 • 7 weeks
Nervous system disorders Confusion	3.3% 1/30 • Number of events 1 • 7 weeks
Musculoskeletal and connective tissue disorders Discomfort to the neck into the upper right shoulder with tingling	3.3% 1/30 • Number of events 1 • 7 weeks
Ear and labyrinth disorders Dizziness	6.7% 2/30 • Number of events 2 • 7 weeks
Nervous system disorders Neck twitched a little during use of the device	3.3% 1/30 • Number of events 1 • 7 weeks
Nervous system disorders Lip drooping during use of the device	3.3% 1/30 • Number of events 1 • 7 weeks
Nervous system disorders Facial drooping	3.3% 1/30 • Number of events 1 • 7 weeks
Renal and urinary disorders Frequent urination	3.3% 1/30 • Number of events 4 • 7 weeks
Respiratory, thoracic and mediastinal disorders Raspiness of voice	3.3% 1/30 • Number of events 1 • 7 weeks
Skin and subcutaneous tissue disorders Neck redness	3.3% 1/30 • Number of events 2 • 7 weeks
Musculoskeletal and connective tissue disorders Neck swelling	3.3% 1/30 • Number of events 1 • 7 weeks
Musculoskeletal and connective tissue disorders Right shoulder pain	3.3% 1/30 • Number of events 1 • 7 weeks
Musculoskeletal and connective tissue disorders Right shoulder spasms	3.3% 1/30 • Number of events 1 • 7 weeks
Infections and infestations Fever	3.3% 1/30 • Number of events 1 • 7 weeks
Musculoskeletal and connective tissue disorders Joint pain	3.3% 1/30 • Number of events 1 • 7 weeks
Ear and labyrinth disorders Tinnitus left ear	3.3% 1/30 • Number of events 1 • 7 weeks

Additional Information

Clinical Affairs

electroCore LLC

Phone: +1 973 355 6683

Email: clinical@electrocore.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60