32
XIII. Clinical Data
(continued)
eTNS was well-tolerated in all 62 subjects and there were no serious adverse events (SAEs)
associated with use of the device. Commonly reported side effects among all pivotal study
subjects included trouble sleeping, hyperactiveness, drowsiness, and stuffy nose, but there was
no statistically significant difference between the active and sham groups for these events.
Events that were more common in the active group than the sham group included: nightmares
(6% versus 0%), headache (13% verus 0%), frequent urination (6% versus 0%), increased
appetite (19% versus 7%), skin rash (6% versus 0%), and teeth clenching (13% versus 7%). The
between group difference for these events was not statistically significant, except in the case
of headache (p = 0.05). Weight gain was only slightly greater in the active group compared to
the sham group (0.6 kg) and was not clinically meaningful given the age group. As noted above,
no participant left the study due to side effects or adverse events in either the pilot or pivotal
study. However, all reported side effects and adverse events were of low to moderate severity
and most were transient.
Percent of Group Reporting Improvement on CGI-I Scale
25%
34%
47%
52%
13%
15%
12%
14%
0%
10%
20%
30%
40%
50%
60%
1
2
3
4
CGI-I for Ac4ve vs. Sham eTNS
Active
Sham
Week
%
Improved
p = 0.25
p = 0.05
P = 0.006
P = 0.003
