Trial Outcomes & Findings for A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache (NCT NCT02991430)
NCT ID: NCT02991430
Last Updated: 2019-06-19
Results Overview
comparison of MHD recorded in baseline month versus 3rd month of treatment
TERMINATED
NA
45 participants
1 month of baseline recordation followed by 84 days of device use
2019-06-19
Participant Flow
Participant milestones
| Measure |
BID Placebo
Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).
|
BID Active
Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).
|
QD Active
Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).
|
|---|---|---|---|
|
Treatment Period 1
STARTED
|
14
|
15
|
16
|
|
Treatment Period 1
COMPLETED
|
13
|
11
|
14
|
|
Treatment Period 1
NOT COMPLETED
|
1
|
4
|
2
|
|
Treatment Period 2
STARTED
|
13
|
11
|
14
|
|
Treatment Period 2
COMPLETED
|
7
|
8
|
10
|
|
Treatment Period 2
NOT COMPLETED
|
6
|
3
|
4
|
|
Post-treatment Observation Period
STARTED
|
7
|
8
|
10
|
|
Post-treatment Observation Period
COMPLETED
|
4
|
2
|
5
|
|
Post-treatment Observation Period
NOT COMPLETED
|
3
|
6
|
5
|
Reasons for withdrawal
| Measure |
BID Placebo
Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).
|
BID Active
Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).
|
QD Active
Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).
|
|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
1
|
0
|
2
|
|
Treatment Period 1
Withdrawal by Subject
|
0
|
4
|
0
|
|
Treatment Period 2
Study Termination
|
6
|
3
|
3
|
|
Treatment Period 2
Lost to Follow-up
|
0
|
0
|
1
|
|
Post-treatment Observation Period
Study Termination
|
3
|
6
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
BID Placebo
n=14 Participants
Participants self-administered twice-daily inactive/sham treatments for 12 weeks followed by twice-daily active treatments for 12 weeks followed by a post-treatment observation period lasting 12 months.
|
BID Active
n=15 Participants
Participants self-administered twice-daily treatments for 12 weeks followed by twice-daily active treatments for an additional 12 weeks followed by a post-treatment observation period lasting 12 months.
|
QD Active
n=16 Participants
Participants self-administered once-daily treatments for 12 weeks followed by once-daily active treatments for an additional 12 weeks followed by a post-treatment observation period lasting 12 months.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 12.2 • n=14 Participants
|
43.9 years
STANDARD_DEVIATION 11.3 • n=15 Participants
|
43.5 years
STANDARD_DEVIATION 10.8 • n=16 Participants
|
43.87 years
STANDARD_DEVIATION 11.28 • n=45 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=14 Participants
|
11 Participants
n=15 Participants
|
14 Participants
n=16 Participants
|
37 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=14 Participants
|
4 Participants
n=15 Participants
|
2 Participants
n=16 Participants
|
8 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Monthly migraine days
|
7.9 days
STANDARD_DEVIATION 1.7 • n=14 Participants
|
7.7 days
STANDARD_DEVIATION 1.9 • n=15 Participants
|
7.5 days
STANDARD_DEVIATION 2.4 • n=16 Participants
|
7.8 days
STANDARD_DEVIATION 2.0 • n=45 Participants
|
PRIMARY outcome
Timeframe: 1 month of baseline recordation followed by 84 days of device usePopulation: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
comparison of MHD recorded in baseline month versus 3rd month of treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month of baseline recordation followed by 84 days of device usePopulation: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month of baseline recordation followed by 84 days of device usePopulation: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
reduction in acute, prescribed medications in month 3 of treatment versus baseline month
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month of baseline recordation followed by 84 days of device usePopulation: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
reduction in subject perceived headache pain scores in month 3 of treatment versus baseline month
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month of baseline recordation followed by 84 days of device usePopulation: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
comparison of HIT-6 (headache impact test) scores between baseline month and treatment month 3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month of baseline recordation followed by 84 days of device usePopulation: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
comparison of BDI-II (Beck depression index) scores between baseline month and treatment month 3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month of baseline recordation followed by 84 days of device usePopulation: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
comparison of BAI (Beck anxiety index) scores between baseline month and treatment month 3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month of baseline recordation followed by 84 days of device usePopulation: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
comparison of Pittsburgh Sleep assessment scores between baseline month and treatment month 3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month of baseline recordation followed by 168 days of device usePopulation: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
comparison of MHD recorded in baseline month versus 6th month of treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month of baseline recordation followed by 252 days of device usePopulation: The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE's were reported over the course of the Study.
comparison of MHD recorded in baseline month versus post-treatment months 7, 8 and 9
Outcome measures
Outcome data not reported
Adverse Events
BID Placebo
BID Active
QD Active
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BID Placebo
n=14 participants at risk
Participants self-administered twice-daily inactive/sham treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).
|
BID Active
n=15 participants at risk
Participants self-administered twice-daily active treatments for 12 weeks (treatment period 1) followed by twice-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).
|
QD Active
n=16 participants at risk
Participants self-administered once-daily active treatments for 12 weeks (treatment period 1) followed by once-daily active treatments for an additional 12 weeks (treatment period 2) followed by a post-treatment observation period lasting 12 weeks (observation period).
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • 11 months
|
20.0%
3/15 • Number of events 3 • 11 months
|
6.2%
1/16 • Number of events 2 • 11 months
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1 • 11 months
|
20.0%
3/15 • Number of events 3 • 11 months
|
6.2%
1/16 • Number of events 2 • 11 months
|
|
Product Issues
Ear discomfort, itch, irritation, pruritis or fullness
|
21.4%
3/14 • Number of events 3 • 11 months
|
46.7%
7/15 • Number of events 9 • 11 months
|
18.8%
3/16 • Number of events 3 • 11 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60