2. Clinical Study Design
Patient
Enrolled
Group A: Active
PNS
Implanted
2:1 Ratio
Randomize and
Device Activation Group B: Control (Blind)
80- to 90-day roll in 4-week visit 12-week visit 24-week visit 52-week visit
The integrity of the Control (or blind) group was maintained as:
1/ Both patients in the Control group, and the study investigator were blinded, so nobody knew
who was active or control
2/ All Control patients were given programmers that appeared to be functioning, but did not
communicate with the IPG (for the first 12 weeks).
3/ Patients in the control group were told that a range of different settings were being
tested which was not indicative of whether they were in the control or active group.
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3. Clinical Study Design
Study Inclusion Criteria Study Exclusion Criteria
Diagnosed with chronic migraine Patients identified as having Medication
Overuse Headache (MOH) - per
headache days/month assessment by study investigator
Has tried at least 2 migraine-specific Patients who within 8 weeks prior to initial
acute medications and at least 2 baseline have started new medications or
different classes of prophylactic therapy to treat headache pain
medications and found to be refractory
Patients who had tried Botox who had tried
VAS score of 6 cm (or greater) 6 months prior to
on a 10-cm line initial baseline
Headache pain is posterior head pain or Patients who have undergone a destructive
pain originating in the cervical region procedure affecting
C2/C3/occipital distribution
Cervical abnormality that does
not allow for placement of the percutaneous
lead
The above inclusion/ exclusion criteria were used in the clinical research to
define the study population for chronic migraine.
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4. Baseline Patient Demographics
Control Group Active Group
(N=52) (N=105)
Mean (+std) 44,6 (+ 10,3) 45,0 (+ 11,3)
Age
Range 23 65 18 72
Male 9 (17,3%) 24 (22,9%)
Gender
Female 43 (82,7%) 81 (77,1%)
Mean (+std) 24,6 + 13,3 21,9 + 14,9
Duration of Headache (yrs)
Range 2,4 54 1,3 66
Baseline Number of Headache
Days
Mean (+std) 72,3 (+ 23,5) 80,7 (+ 18,2)
(out of 90 From MIDAS
Questionnaire)
Study participants in the active and control groups were similar at baseline
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5. Results: Primary Endpoint
50% Reduction in Pain on VAS
Continuous Proportion Responder Analysis Based on Mean Daily Average Pain Intensity
VAS Measurements With No Increase in Average Headache Frequency or Duration
Primary Endpoint:
The primary endpoint in the study was a statistical reference point imposed by
the FDA:
10% differential between responders in active group vs. control group
(95% IC) and,
Responders were defined with 50% reduction (or greater) in mean VAS vs.
baseline
Statistically significant and Clinically relevant for Responders defined at 30%.
Based on feedback from our study investigators this outcome is highly significant in
this patient population particularly when you consider the improvement in disability
and quality of life.
Furthermore it is important to note that a 30% reduction in pain is the mark used by
pharmaceutical companies when they assess whether a specific pain treatment is
efficacious or not.
The study primary end point was not met.
Confidential. For Internal Use Only. St. Jude Medical Neuromodulation Division. in pain. p-value=0,02
Significance was demonstrated at 30% reduction
6. Results: Primary Endpoint
50% Reduction in Pain on Visual Analog Scale
Continuous Proportion Responder Analysis Based on Mean Daily Average Pain Intensity
VAS Measurements With No Increase in Average Headache Frequency or Duration
met
% Control Active
Patients Achieving Various Levels of protocol
reduction Group % Group % p-
Pain Relief from responder responder value1
objective
100% (>10%
baseline s (n=52) s (n=105)
dif.)2
Percentage of Patients
80% 10,0% 30,8% 56,2% 0,003 Yes
20,0% 19,2% 40,0% 0,009 Yes
60%
30,0% 17,3% 35,2% 0,020 Yes
40%
40,0% 15,4% 25,7% 0,143 No
50,0% 13,5% 17,1% 0,553 No
20%
60,0% 9,6% 11,4% 0,731 No
70,0% 1,9% 4,8% 0,664 No
0%
0% 20% 40% 60% 80% 100%
80,0% 1,9% 3,8% 1 No
Percentage of Pain Reduction 90,0% 0,0% 1,0% 1 No
100,0% 0 0 0 No
Control (n=52) Active (n=105)
The study primary end point was not met.
Confidential. For Internal Use Only. St. Jude Medical Neuromodulation Division. in pain. p-value=0,02
Significance was demonstrated at 30% reduction
7. Results: Secondary Endpoints
Reduction in Headache Days at the 12-Week
Control Phase (using patient diary)
Patient diaries recorded whether or not patients had a headache each day, the daily average
headache intensity, and the daily headache duration, in hours.
Data was used to identify Headache Days, defined as a day with a headache lasting four or
more hours with at least moderate intensity.
Visit Control Group (n=52) Active Group (n=105) P-Value
Baseline
Mean ( std) 17,1 ( 8.2) 20,5 ( 7,6) 0,011
Week 12
Mean Change1 -4,3 (25,1%) -7,3 (35,6%) 0,02
Significant reduction -3.0 days in Headache Days (per month) between
Active and Control groups (p=0.02)
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8. Results: Secondary Endpoints
Reduction in MIDAS Disability Score at 12-Week
Control Phase
The Migraine Disability Assessment (MIDAS) is a questionnaire which measures
headache-related disability during the previous 90 days.
Visit Control Group (n=52) Active Group (n=105) P-Value
Baseline
Mean ( std) 152,7 ( 77,1) 158,4 ( 76,8) 0,664
Week 12
Mean Change1 -20,4 -64,6 <0,001
The MIDAS questionnaire was completed at baseline and 12 weeks after the system
was implanted.
The reduction in disability of 44.1 days between the groups is statistically significant
(p<0.001).
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9. Results: Pain Relief & Patient Satisfaction
12-Week Control Phase
Active group participants reported (on average) 42,1% pain relief and 51,4% of them
were satisfied with their level of pain relief.
Percentage of Pain Relief Since Percentage of Patients Satisfied
Surgery With Headache Relief
100%
100%
80%
80%
60%
60% 51,4%
42,1%
40% 40%
17,2% 19,2%
20% 20%
0% 0%
Control Group (n=52) Active Group (n=105)
Control Group (n=52) Active Group (n=105)
The differences reported between the Active and Control Groups for both
measures were statistically significant (p<0,001).
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10. Results: Quality of Life & Patient Assessment -
Open Label Phase
Overall Quality of Life Were you satisfied with the results of your
100% procedure? (N=138)
4%
80% n=6
68,4%
64,3%
60%
Very Satisfied
15% 23%
n=21 n=32 Satisfied
40%
30,0%
14% Unsatisfied
26,3% n=19
Very Unsatisfied
20% 44%
n=60 Unable to Determine
5,7% 5,3%
0%
Improved Stayed the Same Deteriorated
Week 24 (N=140) Week 52 (N=133)
At the conclusion of the study 68.4% pts reported improved QOL, and 67% were
either satisfied or very satisfied w/ the results of the therapy.
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