Trial Outcomes & Findings for Non-invasive Neurostimulation for the Relief of Migraine (NCT NCT03410628)

Results Overview

Safety was assessed by collecting adverse events for the duration of the study

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

Up to 4 months

Results posted on

2018-07-26

Participant Flow

Participant milestones

Participant milestones
Measure	gammaCore Active Device open label gammaCore: Non-invasive vagal nerve stimulator
Overall Study STARTED	21
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Non-invasive Neurostimulation for the Relief of Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	gammaCore Active Device n=21 Participants open label gammaCore: Non-invasive vagal nerve stimulator
Age, Continuous	38.6 years n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized White	17 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Region of Enrollment South Africa	21 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 months

Population: safety population

Safety was assessed by collecting adverse events for the duration of the study

Outcome measures

Outcome measures
Measure	gammaCore Active Device n=21 Participants open label gammaCore: Non-invasive vagal nerve stimulator
Safety - Number of Participants With Adverse Events	1 Participants

SECONDARY outcome

Timeframe: 120 minutes

Population: Safety population, 6 subjects had missing data

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.

Outcome measures

Outcome measures
Measure	gammaCore Active Device n=15 Participants open label gammaCore: Non-invasive vagal nerve stimulator
Change in Headache Pain Severity From Baseline to 120 Minutes for First Treated Migraine Attack Headache pain severity at Baseline	2.2 units on a scale Interval 1.0 to 3.0
Change in Headache Pain Severity From Baseline to 120 Minutes for First Treated Migraine Attack Headache pain severity at 120 minutes	1.2 units on a scale Interval 0.0 to 3.0

Adverse Events

gammaCore Active Device

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	gammaCore Active Device n=21 participants at risk open label gammaCore: Non-invasive vagal nerve stimulator
Gastrointestinal disorders Diarrhea	4.8% 1/21 • Number of events 2 • 24 weeks

Additional Information

Clinical Affairs

electroCore Inc.

Phone: +1 973 355 6683

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60