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64000-00120 Rev 3

Acute migraine headache clinical study
Clinical data demonstrating the safety and effectiveness of gammaCore for the acute treatment of

migraine headache is presented from one prospective, double-blind, sham-controlled, randomized

clinical trial (The PRESTO Study).

Summary
This randomized sham-controlled trial demonstrated the safety and efficacy of gammaCore for the

acute treatment of episodic migraine with or without aura. gammaCore was safe and well tolerated in

this study.

gammaCore for the acute treatment of migraine headache: The PRESTO Study
In the PRESTO Study, subjects were instructed to treat their migraine headache within twenty minutes

of the onset of pain. Each self-administered treatment consisted of bilateral 120-second stimulations to

the right and left sides of the neck. If the pain had not decreased fifteen minutes after initial treatment,

subjects were instructed to repeat the bilateral stimulations, and if not pain-free two hours after initial

treatment, a third set of bilateral stimulations was allowed.

Figure 5. PRESTO Treatment Protocol

Demographics
The PRESTO study enrolled a total of 243 patients with migraine. General demographics are

provided in the following table:

Note: The remainder of this page was intentionally left blank.

Содержание gammaCore-S

Страница 1: ...1 9 HOW TO USE gammaCore 12 10 CLEANING 17 11 PRODUCT HANDLING 17 12 PRODUCT DISPOSAL 17 13 SYMBOLS AND NOMENCLATURE DESCRIPTION 18 14 ORDERING INFORMATION 19 15 PRODUCT ORDERS AND RETURNS 19 ADDITIONAL INFORMATION FOR HEALTHCARE PROVIDERS 20 16 PRODUCT DESCRIPTION 21 17 WARNINGS AND PRECAUTIONS 22 18 POTENTIAL ADVERSE REACTIONS 25 19 CLINICAL STUDIES 26 20 CONTACT INFORMATION 47 Caution Rx Only U...

Страница 2: ...effectiveness of this device is based on a comparison of its low risks and probable benefit to health The FDA has determined probable benefit to health based on the patient s stated preference for the device For prescription use only 2 WHAT SHOULD I EXPECT People respond differently to nVNS Acute treatment of episodic cluster headache Based on the clinical trials conducted with gammaCore and unles...

Страница 3: ...reatment consisting of two 2 minute stimulations one on the right side of the neck one on the left side of the neck If you are not pain free two hours after the start of your first treatment you may administer a third treatment consisting of two 2 minute stimulations one on the right side of the neck one on the left side of the neck For migraine headache One treatment is defined as two consecutive...

Страница 4: ...rotic cardiovascular disease including congestive heart failure CHF known severe coronary artery disease or recent myocardial infarction within 5 years o Patients with a history of a prolonged QT interval or arrhythmia o Patients with a history of an abnormal baseline ECG e g second and third degree heart block atrial fibrillation atrial flutter recent history of ventricular tachycardia or ventric...

Страница 5: ...ontact electroCore Customer Service for an electroCore approved gel that works with the device Remove jewelry that may touch the treatment location necklaces earrings etc before treating with gammaCore Always carefully examine the device for any signs of damage or defects before use Do not share your gammaCore with another person Do not use gammaCore if The stimulation surfaces are broken or crack...

Страница 6: ...devices mobile phones cordless telephones and their base stations and walkie talkies can affect this equipment Keep gammaCore at least 3 3 meters away from these items while in use 5 POTENTIAL RISKS AND COMPLICATIONS Shortness of breath dyspnea hoarseness or change in voice during treatment Muscle twitching discomfort or pain during stimulation Change of taste dysgeusia The above should resolve af...

Страница 7: ...e Display Display Description Stimulations Remaining 9 stimulations remaining Stimulation Intensity Stimulation intensity at 20 V symbol indicates a signal at stimulation surfaces Days Remaining 15 days remaining until device expires and will not deliver stimulations Stimulation Last stimulation intensity Intensity at Last Use ...

Страница 8: ...Ready for Use Green Light On 1 Number of Days Remaining 2 Number of Stimulations Remaining 1 short beep after power ON Follow How to Use Instructions Device in Use Green Light On is not an indicator that there is a signal at the stimulation surfaces Stimulation Intensity min 1 max 40 Short beep each time or button is pressed Follow How to Use Instructions Note The remainder of this page was intent...

Страница 9: ...NONE Device turns off automatically Error Flashing Green Light Repeated long beeps Device turns off automatically after 10 seconds Turning off and on again may clear error No Stimulations Remaining Flashing Green Light Repeated long beeps Device turns off automatically Replace device Expired No Days Left Flashing Green Light Repeated long beeps Device turns off automatically Replace device ...

Страница 10: ... Turn On None None None Press the and buttons at the same time for 10 seconds and then release Wait 5 seconds and press the top button again to turn the device on Dead Battery None None None Replace device Contact electroCore Customer Service if error is not cleared or to order a new device Note The remainder of this page was intentionally left blank ...

Страница 11: ...BUTTON FUNCTIONS Button Button and Buttons pressed at the same time Turns device ON Increases stimulation intensity Decreases stimulation intensity Turns device OFF Note The remainder of this page was intentionally left blank ...

Страница 12: ... finding the pulse on the side of the neck The vagus nerve is in the same area Make sure the treatment location is clean and dry 9 HOW TO USE gammaCore Jaw Muscle Windpipe Treatment Location Pulse The stimulation surfaces of the device will line up with the following landmarks Over the pulse orange In front of the large muscle at the side of the neck yellow Just below the lower jaw blue Lined up n...

Страница 13: ...mfortable or less effective CAUTION Only use an electroCore approved gel with gammaCore Please contact electroCore Customer Service for an electroCore approved gel that works with the device Refer to Section 22 6 Turn gammaCore on by pressing the top button When the device is ready for use the light will turn green and the device will beep once The number of stimulations available and days remaini...

Страница 14: ... pulse and slowly increasing the stimula tion intensity again by pressing the button If the stimulation is still intolerable turn the device off by pressing the and buttons at the same time and discontinue the stimulation CAUTION Do not turn gammaCore on again until preparing for the next treatment The device counts each time the stimulation intensity is higher than three 3 as a stimulation The de...

Страница 15: ...timulation intensity before automatically turning off NOTE A stimulation stops automatically after 120 seconds The device will make 2 short beeps and automatically stop stimulation NOTE The number of days and stimulations remaining can be viewed by turning the device on However do not turn the stimulation intensity higher than three 3 until preparing for a stimula tion The device counts each time ...

Страница 16: ... stimulation should be applied to the left side of the neck If the pain has not decreased twenty minutes after the start of your first treatment you may administer an additional treatment consisting of two 2 minute stimulations one on the right side of the neck one on the left side of the neck If you are not pain free two hours after the start of your first treatment you may administer a third tre...

Страница 17: ...ansport Conditions gammaCore should be stored at room temperature away from moisture Range 0 to 38 C 32 to 100 F Humidity 10 90 Barometric Pressure less than 80 kPa Replace caps after each use Store device in such a way e g drawer or shelf so that the caps remain in place and are not inadvertently removed Service Life The service life of gammaCore is 1 5 years after the date of manufacture refer t...

Страница 18: ...mospheric pressure range Relative humidity range MR unsafe Authorized representative Expiration date Lot number Catalogue number Reference number Electric shock hazard Serial number Non sterile WARNING Failure to follow instructions may result in serious injury or death to the patient or user PRECAUTION Failure to follow instructions may result in damage to the equipment or degradation in the qual...

Страница 19: ...Number Description 10009 40601 gammaCore 31 Day 40000 00103 Conductive Gel 15 PRODUCT ORDERS AND RETURNS Returns of a non working device should be reported to electroCore customer service For Contact Information refer to Section 22 Note The remainder of this page was intentionally left blank ...

Страница 20: ...20 64000 00120 Rev 3 20 64000 00120 Rev 3 ADDITIONAL INFORMATION FOR HEALTHCARE PROVIDERS ...

Страница 21: ...nt of episodic cluster headache Each self administered treatment should consist of three 2 minute stimulations applied consecutively at the onset of cluster headache pain or symptoms If the cluster headache attack is not aborted an additional three consecutive 2 minute stimulations three minutes after the first treatment may be administered Treatments may be applied to either side of the neck gamm...

Страница 22: ...tients with clinically significant hypertension hypotension bradycardia or tachycardia o Patients with an abnormal cervical anatomy o Patients with a history of brain tumor o Patients with aneurysms o Patients with bleed or head trauma o Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease including congestive heart failure CHF known severe coronary artery ...

Страница 23: ...were applied Treatments were applied to either side of the neck on up to 4 attacks or 8 separate treatments per day for a total of up to 24 stimulations per day Use of more than 8 gammaCore treatments per day for a total of 24 stimulations per day for the acute treatment of episodic cluster headache was not evaluated Clinical studies summarized below for the acute treatment of migraine headache ev...

Страница 24: ...ocation out of reach of children o Not to use the device after its expiration date The expiration date is indicated on the device packaging o To contact electroCore Customer Service if the device is not working They should not attempt to open the case replace the battery or disassemble repair or modify the device o That they should not submerge splash or expose gammaCore to water or other liquids ...

Страница 25: ... resolve after treatment is complete o Paresthesia or dysaesthesia lasting beyond the treatment period o Skin irritation due to allergic reaction to gel o Diarrhea nausea vomiting or loss of appetite o Sweating o Fatigue depressed mood o Tinnitus o Progression of headache symptoms o Abnormal heart rhythm Potential risks associated with non invasive vagus nerve stimulation that may be moderate to s...

Страница 26: ...evice in the total patient population which included patients with episodic cluster headache eCH and chronic cluster headache cCH In both studies there was a significant improvement over sham demonstrated in patients with eCH but not cCH which affected the results in the total study population Study 1 gammaCore for the acute treatment of episodic cluster headache The ACT1 Study In the ACT1 Study s...

Страница 27: ...0 84 83 2 42 85 7 Race No Asian 4 5 5 1 1 3 4 4 0 1 2 0 Black 5 6 9 7 9 1 9 8 9 3 6 1 White 63 86 3 68 88 3 87 86 1 44 89 8 Missing 1 1 4 1 1 3 1 1 0 1 2 0 Duration of last CH attack min mean SD 86 119 64 71 76 5 104 4 68 9 75 0 CH Type No eCH 50 68 5 51 66 2 101 100 0 0 cCH 23 31 5 26 33 8 0 49 100 0 Medications Used to Manage CH No Triptans 42 57 5 54 70 1 68 67 3 28 57 1 Oxygen 31 42 5 29 37 7 ...

Страница 28: ...nt total nVNS 26 7 sham 12 3 P 0 04 eCH nVNS 34 2 sham 10 6 P 0 01 For the cCH cohort sustained response rates were similar between groups nVNS 13 6 sham 15 4 P 1 0 For the total population and both cohorts the average of all subjects mean pain intensities at 15 minutes after treatment for all CH attacks was not significantly different between the nVNS and sham treatment groups total nVNS 2 1 sham...

Страница 29: ...am nVNS Sham nVNS Sham End Point n 60 n 73 n 38 n 47 n 22 n 26 Primary end point all subjects Response rate a 26 7 15 1 34 2 10 6 13 6 23 1 16 60 11 73 13 38 5 47 3 22 6 26 95 CI 16 1 39 7 7 8 25 4 19 6 51 4 3 6 23 1 2 9 34 9 9 0 43 7 P value 0 1 0 01 0 48 Secondary end points all subjects Sustained Treatment 26 7 12 3 34 2 10 6 13 6 15 4 response rate a 16 60 9 73 13 38 5 47 3 22 4 26 95 CI 16 1 ...

Страница 30: ...Burning tingling soreness stinging 2 2 7 7 9 1 4 3 1 Skin irritation redness erythema 0 9 11 7 2 1 6 Musculoskeletal disorders Lip or facial drooping pulling twitching 8 11 0 0 9 7 0 Nervous system disorders Dysgeusia metallic taste 0 7 9 1 2 1 6 Abbreviations ADE adverse device effect AE adverse event nVNS non invasive vagus nerve stimulation a Serious AE of cluster headache 2 occurrences b Serio...

Страница 31: ...cts were instructed to treat their cluster headache attack at the onset of pain with three 2 minute stimulations Figure 4 If pain was still present at nine minutes the subjects had the option of treating with an additional three 2 minute stimulations Figure 4 ACT2 Treatment Protocol Note The remainder of this page was intentionally left blank ...

Страница 32: ...nic origin No White 49 98 0 52 100 0 30 100 0 71 98 6 Black 0 0 0 0 Asian 1 2 0 0 0 1 1 4 Duration of CH attacks during run in period mean SD min 69 9 68 7 77 4 76 9 69 6 83 3 76 1 69 0 CH Type No eCH 15 30 0 15 28 8 30 100 0 0 cCH 35 70 0 37 71 2 0 72 100 0 Medications used to manage CH No Triptans 37 74 0 34 65 3 19 63 3 52 72 2 Oxygen 27 54 0 31 59 6 20 66 7 38 52 8 Mild analgesics 7 14 0 6 11 ...

Страница 33: ...ore treatment was significantly better than the sham results in the total population but did not achieve significance in the eCH or cCH cohorts total nVNS 43 sham 28 P 0 05 eCH nVNS 58 sham 25 P 0 07 cCH nVNS 37 sham 28 P 0 34 In patients with eCH there was a significant reduction in their reported average pain intensity 15 minutes after treatment on a five point scale nVNS 1 7 sham 0 6 P 0 01 tha...

Страница 34: ...tified by site All Subjects eCH Cohort cCH Cohort nVNS Sham nVNS Sham nVNS Sham End Point n 48 n 44 n 14 n 13 n 34 n 31 Primary end point all subjects Attacks that were pain free 13 5 11 5 47 5 6 2 4 8 12 9 at 15 min n N a 67 495 46 400 48 101 5 81 19 394 41 319 Odds ratio 95 CI 1 22 0 42 3 51 9 19 1 77 47 80 0 41 0 13 1 30 P valueb 0 71 0 01 0 13 Secondary end points all subjects Percentage of at...

Страница 35: ... No 23 46 0 22 42 3 28 33 7 Subjects with 1 serious AE No 1 2 0 a 1 1 9 b 0 Subjects with 1 ADE No 13 26 0 13 25 0 14 16 9 ADEs Occurring in 5 of subjects in any Treatment Group No No ADEs occurred in 5 of subjects in any treatment group a One subject in the gammaCore group reported severe lower abdominal and lower back pain These events were not considered related to treatment and resolved withou...

Страница 36: ...6 60 26 7 16 1 39 7 11 73 15 1 7 8 25 4 0 10 Episodic CH 13 38 34 2 19 6 51 4 5 47 10 6 3 6 23 1 0 01 Chronic CH 3 22 13 6 2 9 34 9 6 26 23 1 9 0 43 7 0 48 ACT2 Population Total 18 48 37 5 23 4 51 6 13 44 29 5 15 7 43 4 0 35 Episodic CH 7 14 50 0 21 1 78 9 2 13 15 4 0 37 2 0 06 Chronic CH 11 34 32 4 16 0 48 7 11 31 35 5 17 9 53 0 0 79 In each of the studies nVNS showed a significant ACT1 and or cl...

Страница 37: ...04 Chronic CH 19 394 4 8 7 4 3 3 15 9 41 319 12 9 9 2 4 3 18 6 0 69 a Number of successful responses number of attacks b Generalized linear mixed effects regression models SAS proc glimmix were utilized to estimate the proportion of successful responses allowing for both subject specific and population averaged inference in non normally distributed data P values for comparison between nVNS and sha...

Страница 38: ...aine headache The PRESTO Study In the PRESTO Study subjects were instructed to treat their migraine headache within twenty minutes of the onset of pain Each self administered treatment consisted of bilateral 120 second stimulations to the right and left sides of the neck If the pain had not decreased fifteen minutes after initial treatment subjects were instructed to repeat the bilateral stimulati...

Страница 39: ...9 4 11 2 28 5 11 5 Female No 95 79 2 91 74 0 Race No Asian 0 0 Black 0 0 White 120 100 123 100 Other 0 0 Migraine Type No Migraine with aura 8 6 7 9 7 3 Migraine without aura 112 93 3 114 92 7 Attacks in the last 4 weeks No mean SD 5 4 1 7 5 3 1 7 Headache days in the last 4 weeks No mean SD 6 3 2 3 6 2 2 1 Attacks per month in the last 6 months No mean SD 5 4 1 5 5 4 1 5 Acute migraine medication...

Страница 40: ...s Results for the secondary endpoints further demonstrated significant clinical benefits of gammaCore The mean percentage change in pain score from baseline to 120 minutes for all attacks in the double blind period was 34 8 in the nVNS group and 5 4 in the sham group p 0 004 Responder rates for mild or no pain at 120 minutes were significantly higher with nVNS 40 8 than with sham 27 6 for the firs...

Страница 41: ...propriate 4 p Values were derived from 2 sample t tests 5 For patients who had 2 treated migraine attacks 30 Min 60 Min 120 Min gammaCore Sham gammaCore Sham gammaCore Sham Primary endpoint pain free logistic regession1 12 7 4 2 21 0 10 0 30 4 19 7 95 CI 7 2 21 6 1 7 9 6 14 1 30 1 5 6 17 4 22 2 39 9 13 0 28 6 p Value 0 012 0 023 0 067 30 60 and 120 minutes repeated measures1 2 Odds Ratio 2 3 95 CI...

Страница 42: ...us nerve stimulation Data are No of subjects Note The remainder of this page was intentionally left blank gammaCore Sham AEs and ADEs n 122 n 126 Patients with 1 AE No 22 18 0 23 18 3 Patients with 1 serious AE 0 0 Patients with 1 ADE 7 5 7 10 7 9 Patients with 1 AE leading to discontinuation 0 2 1 59 AEs Occurring in 2 of Patients in Any Treatment Group n 122 n 126 General disorders and administr...

Страница 43: ...ntitle electroCore to terminate the license Customer Service Limited Liability gammaCore is guaranteed against defects in materials function and workmanship for the lesser of 1 one year or 2 the expiration date of the product whether it expires due to completion of all of the treatments or expires due to the time limit set on the product electroCore shall not be liable expressly or implied for any...

Страница 44: ...electroCore LLC 150 Allen Road Suite 201 Basking Ridge New Jersey 07920 United States 1 888 903 2673 www electrocore com ...

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