Trial Outcomes & Findings for External Trigeminal Nerve Stimulation for Epilepsy (NCT NCT01159431)

NCT ID: NCT01159431

Last Updated: 2013-06-03

Results Overview

Change in responder rate, at end of study (18 weeks) Absolute percent of subjects with 50% reduction in seizures, 18 weeks compared with 6 weeks Note, the number is not a mean or median, but a fixed percentage.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: Treatment period, 18 weeks (end of double blind period) compared with first 6 weeks
• Results posted on: 2013-06-03

Participant Flow

Subjects were recruited beginning at Olive View/UCLA and Keck-USC between 3/2008 and 10/2010

6-week pretreatment baseline

Participant milestones

Measure	Active Trigeminal Nerve Stimulation-High Settings	Control Trigeminal Nerve Stimulation-Low Settings
Overall Study STARTED	25	25
Overall Study COMPLETED	23	19
Overall Study NOT COMPLETED	2	6

Reasons for withdrawal

Measure	Active Trigeminal Nerve Stimulation-High Settings	Control Trigeminal Nerve Stimulation-Low Settings
Overall Study Adverse Event	1	2
Overall Study non-compliance	1	1
Overall Study Lack of Efficacy	0	3

Baseline Characteristics

External Trigeminal Nerve Stimulation for Epilepsy

Baseline characteristics by cohort

Measure	Active n=25 Participants Trigeminal Nerve Stimulation-High Settings	Control n=25 Participants Trigeminal Nerve Stimulation-Low Settings	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	33.1 years STANDARD_DEVIATION 10.57 • n=5 Participants	34.2 years STANDARD_DEVIATION 10.81 • n=7 Participants	33.44 years STANDARD_DEVIATION 10.58 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	11 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Treatment period, 18 weeks (end of double blind period) compared with first 6 weeks

Change in responder rate, at end of study (18 weeks)

Absolute percent of subjects with 50% reduction in seizures, 18 weeks compared with 6 weeks Note, the number is not a mean or median, but a fixed percentage.

Outcome measures

Measure	Treatment n=23 Participants Trigeminal Nerve Stimulation-High Settings	Control n=19 Participants Trigeminal Nerve Stimulation-Low Settings	Treatment Group-Baseline	Treatment Group-Double Blind Period
50% Responder Rate	40.5 percentage of participants	15.6 percentage of participants	—	—

PRIMARY outcome

Timeframe: treatment period (18-weeks)

Number of Days to the 4th seizure

Outcome measures

Measure	Treatment n=25 Participants Trigeminal Nerve Stimulation-High Settings	Control n=19 Participants Trigeminal Nerve Stimulation-Low Settings	Treatment Group-Baseline n=25 Participants	Treatment Group-Double Blind Period n=23 Participants
Time to the 4th Seizure	23 days Standard Deviation 19	18 days Standard Deviation 31	12.5 days Standard Deviation 18	15 days Standard Deviation 28

PRIMARY outcome

Timeframe: 18 weeks

Percent change in seizure frequency from baseline

Outcome measures

Measure	Treatment n=23 Participants Trigeminal Nerve Stimulation-High Settings	Control n=19 Participants Trigeminal Nerve Stimulation-Low Settings	Treatment Group-Baseline	Treatment Group-Double Blind Period
Change in Seizure Frequency	-16.1 percentage change in seizures per month Standard Deviation 15.4	-10.5 percentage change in seizures per month Standard Deviation 11.1	—	—

SECONDARY outcome

Timeframe: 18 weeks

Response Ratio: Mean Percent Change in seizures over the treatment period, where [T-B] / [T+B] x 100%, where T = seizure frequency during the treatment period, and B = seizure frequency during the baseline period.

Outcome measures

Measure	Treatment n=23 Participants Trigeminal Nerve Stimulation-High Settings	Control n=19 Participants Trigeminal Nerve Stimulation-Low Settings	Treatment Group-Baseline	Treatment Group-Double Blind Period
Response Ratio: Mean Percent Change in Seizures	-13.9 percentage change of RRATIO Standard Deviation 6.7	-9.0 percentage change of RRATIO Standard Deviation 6.8	—	—

SECONDARY outcome

Timeframe: 18-weeks

Mean change in score on the Beck Depression Inventory. The Beck Inventory is a patient reported mood scale. The minimum score is 0, and the maximum score is 63. Scores of less than 10 are considered in the normal range. Scores above 10 are consistent with depression. Higher scores indicate higher degrees of depression, with scores of > 25 consistent with severe depression.

Outcome measures

Measure	Treatment n=23 Participants Trigeminal Nerve Stimulation-High Settings	Control n=19 Participants Trigeminal Nerve Stimulation-Low Settings	Treatment Group-Baseline	Treatment Group-Double Blind Period
Mood	-8.13 units on a scale Standard Deviation 1.35	-3.95 units on a scale Standard Deviation 1.22	—	—

Adverse Events

Active

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Active n=25 participants at risk Trigeminal Nerve Stimulation-High Settings	Control n=25 participants at risk Trigeminal Nerve Stimulation-Low Settings
Nervous system disorders Seizure cluster	0.00% 0/25 • 18-weeks anxiety	4.2% 1/24 • Number of events 1 • 18-weeks anxiety

Other adverse events

Measure	Active n=25 participants at risk Trigeminal Nerve Stimulation-High Settings	Control n=25 participants at risk Trigeminal Nerve Stimulation-Low Settings
Skin and subcutaneous tissue disorders skin irritation	16.0% 4/25 • Number of events 4 • 18-weeks anxiety	12.0% 3/25 • Number of events 3 • 18-weeks anxiety
Nervous system disorders headache	0.00% 0/25 • 18-weeks anxiety	4.0% 1/25 • Number of events 1 • 18-weeks anxiety
Psychiatric disorders Anxiety	4.0% 1/25 • Number of events 1 • 18-weeks anxiety	0.00% 0/25 • 18-weeks anxiety

Additional Information

Dr. Christopher DeGiorgio

UCLA

Phone: 310-206-3753

Email: cmd@mednet.ucla.edu

Results disclosure agreements

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