Trial Outcomes & Findings for Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine (NCT NCT01709708)
NCT ID: NCT01709708
Last Updated: 2018-01-26
Results Overview
Compare Numeric Rating Scale (NRS) scores Before Procedure,15-Minute Post Treatment, 30-Minutes Post Treatment, 24-Hour Post Treatment for all 12 treatments (Marcaine vs. Saline). NRS is a likert scale ranging from 0-10 with 0 being no pain and 10 being worst possible pain. For each individual time point, all 12 treatments were averaged for that time point and a single value was used for comparison between the two groups.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
6 Weeks
Results posted on
2018-01-26
Participant Flow
Participant milestones
| Measure |
Marcaine
Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.
|
Saline
Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
14
|
|
Overall Study
COMPLETED
|
26
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Marcaine
Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.
|
Saline
Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
2
|
Baseline Characteristics
Use of the Tx360 Nasal Applicator in the Treatment of Chronic Migraine
Baseline characteristics by cohort
| Measure |
Marcaine
n=27 Participants
Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.
|
Saline
n=14 Participants
Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.96 years
STANDARD_DEVIATION 11.63 • n=5 Participants
|
41.97 years
STANDARD_DEVIATION 14.71 • n=7 Participants
|
41.30 years
STANDARD_DEVIATION 12.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 WeeksCompare Numeric Rating Scale (NRS) scores Before Procedure,15-Minute Post Treatment, 30-Minutes Post Treatment, 24-Hour Post Treatment for all 12 treatments (Marcaine vs. Saline). NRS is a likert scale ranging from 0-10 with 0 being no pain and 10 being worst possible pain. For each individual time point, all 12 treatments were averaged for that time point and a single value was used for comparison between the two groups.
Outcome measures
| Measure |
Marcaine
n=26 Participants
Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.
|
Saline
n=12 Participants
Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
|
|---|---|---|
|
Numeric Rating Scale (NRS)
Before Procedure
|
3.18 units on a scale
Standard Deviation 2.79
|
3.78 units on a scale
Standard Deviation 2.48
|
|
Numeric Rating Scale (NRS)
15 Minutes Post Treatment
|
2.53 units on a scale
Standard Deviation 2.61
|
3.51 units on a scale
Standard Deviation 2.39
|
|
Numeric Rating Scale (NRS)
30 Minutes Post Treatment
|
2.41 units on a scale
Standard Deviation 2.61
|
3.45 units on a scale
Standard Deviation 2.36
|
|
Numeric Rating Scale (NRS)
24 Hours Post Treatment
|
2.85 units on a scale
Standard Deviation 2.74
|
4.20 units on a scale
Standard Deviation 2.62
|
SECONDARY outcome
Timeframe: 15 Minutes Post Treatment, 30 minutes Post Treatment and 24 hours Post Treatment, assessed up to 6 weeksCompare percentage change in Numeric Rating Scale (NRS) score from Before Procedure to 15-Minutes, Before Procedure to 30-Minutes, Before Procedure to 24-Hours After Procedure for all 12 treatments (Mean of all 12 treatments for each timepoint, comparing Group A to Group B). NRS is a likert scale ranging from 0-10 with 0 being no pain and 10 being worst possible pain.
Outcome measures
| Measure |
Marcaine
n=26 Participants
Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.
|
Saline
n=12 Participants
Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
|
|---|---|---|
|
Change in Numeric Rating Scale (NRS)
15 Minutes Post Treatment
|
-23.3 percentage of change
Standard Deviation 34.5
|
-4.31 percentage of change
Standard Deviation 27.3
|
|
Change in Numeric Rating Scale (NRS)
30 Minutes Post Treatment
|
-27.7 percentage of change
Standard Deviation 37.1
|
-5.41 percentage of change
Standard Deviation 29.2
|
|
Change in Numeric Rating Scale (NRS)
24 Hours Post Treatment
|
-15.5 percentage of change
Standard Deviation 69.9
|
13.5 percentage of change
Standard Deviation 78.8
|
SECONDARY outcome
Timeframe: 30 minutes Post Treatment and 24 hours Post Treatment, assessed up to 6 weeksCompare 24-Hour After Procedure Patient's Global Impression of Change (PGIC) score for 12 treatments (Mean of all 12 treatments for each timepoint, comparing Group A to Group B). PGIC is a likert scale ranging from 1 to 7 with 1 being very much improved and 7 being very much worse.
Outcome measures
| Measure |
Marcaine
n=26 Participants
Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.
|
Saline
n=12 Participants
Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
|
|---|---|---|
|
Patient's Global Impression of Change (PGIC)
30 Minutes Post Treatment
|
3.00 units on a scale
Standard Deviation 1.02
|
3.72 units on a scale
Standard Deviation 0.53
|
|
Patient's Global Impression of Change (PGIC)
24 Hours Post Treatment
|
3.08 units on a scale
Standard Deviation 1.26
|
3.88 units on a scale
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: Before Treatment, 24 Hours After Treatment, 1 Month Post Treatment, and 6 Months Post TreatmentCompare Modified Pain Characteristic Questionnaire scores Before Procedure vs. 24-Hour After Procedure, Before Procedure vs. 1-Month Follow Up, and Before Procedure vs. 6-Month Follow Up (Mean of all 12 treatments for each timepoint, comparing Group A to Group B). The modified pain characteristic questionnaire is a series of 11 questions on a likert scale ranging from 0 to 10 with 0 being no pain or does not interfere and 10 being worst pain or completely interferes. Percentage questions range from 0 to 100.
Outcome measures
| Measure |
Marcaine
n=26 Participants
Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.
|
Saline
n=12 Participants
Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
|
|---|---|---|
|
Modified Pain Characteristic Questionnaire
Worst Pain Question: Before Treatment
|
4.75 units on a scale
Standard Deviation 3.11
|
6.15 units on a scale
Standard Deviation 2.65
|
|
Modified Pain Characteristic Questionnaire
Worst Pain Question: 24 Hours After Treatment
|
4.36 units on a scale
Standard Deviation 3.01
|
6.16 units on a scale
Standard Deviation 2.44
|
|
Modified Pain Characteristic Questionnaire
Worst Pain Question: 1 Month Post Treatment
|
4.56 units on a scale
Standard Deviation 3.23
|
5.64 units on a scale
Standard Deviation 3.04
|
|
Modified Pain Characteristic Questionnaire
Worst Pain Question: 6 Months Post Treatment
|
4.27 units on a scale
Standard Deviation 3.10
|
5.88 units on a scale
Standard Deviation 1.73
|
|
Modified Pain Characteristic Questionnaire
Least Pain Question: Before Treatment
|
2.01 units on a scale
Standard Deviation 2.55
|
2.50 units on a scale
Standard Deviation 2.13
|
|
Modified Pain Characteristic Questionnaire
Least Pain Question: 24 Hours After Treatment
|
1.77 units on a scale
Standard Deviation 2.49
|
2.43 units on a scale
Standard Deviation 1.93
|
|
Modified Pain Characteristic Questionnaire
Least Pain Question: 1 Month Post Treatment
|
1.88 units on a scale
Standard Deviation 2.62
|
2.64 units on a scale
Standard Deviation 2.11
|
|
Modified Pain Characteristic Questionnaire
Least Pain Question: 6 Months Post Treatment
|
1.68 units on a scale
Standard Deviation 2.03
|
2.88 units on a scale
Standard Deviation 2.47
|
|
Modified Pain Characteristic Questionnaire
Average Pain Question: Before Treatment
|
3.39 units on a scale
Standard Deviation 2.61
|
4.33 units on a scale
Standard Deviation 2.29
|
|
Modified Pain Characteristic Questionnaire
Average Pain Question: 24 Hours After Treatment
|
3.07 units on a scale
Standard Deviation 2.57
|
4.27 units on a scale
Standard Deviation 2.09
|
|
Modified Pain Characteristic Questionnaire
Average Pain Question: 1 Month Post Treatment
|
3.36 units on a scale
Standard Deviation 2.87
|
3.91 units on a scale
Standard Deviation 2.30
|
|
Modified Pain Characteristic Questionnaire
Average Pain Question: 6 Months Post Treatment
|
2.86 units on a scale
Standard Deviation 2.62
|
4.00 units on a scale
Standard Deviation 2.27
|
|
Modified Pain Characteristic Questionnaire
Percent Relief Question: Before Treatment
|
41.3 units on a scale
Standard Deviation 36.5
|
29.2 units on a scale
Standard Deviation 33.0
|
|
Modified Pain Characteristic Questionnaire
Percent Relief Question: 24 Hours After Treatment
|
46.0 units on a scale
Standard Deviation 38.2
|
29.8 units on a scale
Standard Deviation 32.5
|
|
Modified Pain Characteristic Questionnaire
Percent Relief Question: 1 Month Post Treatment
|
46.3 units on a scale
Standard Deviation 39.9
|
21.0 units on a scale
Standard Deviation 32.1
|
|
Modified Pain Characteristic Questionnaire
Percent Relief Question: 6 Months Post Treatment
|
34.7 units on a scale
Standard Deviation 29.2
|
18.6 units on a scale
Standard Deviation 30.8
|
|
Modified Pain Characteristic Questionnaire
General Activity Question: Before Treatment
|
2.49 units on a scale
Standard Deviation 2.96
|
3.50 units on a scale
Standard Deviation 2.70
|
|
Modified Pain Characteristic Questionnaire
General Activity Question: 24 Hours After Treatmen
|
2.31 units on a scale
Standard Deviation 2.90
|
3.64 units on a scale
Standard Deviation 2.78
|
|
Modified Pain Characteristic Questionnaire
General Activity Question: 1 Month Post Treatment
|
2.64 units on a scale
Standard Deviation 2.91
|
3.91 units on a scale
Standard Deviation 2.81
|
|
Modified Pain Characteristic Questionnaire
General Activity Question: 6 Months Post Treatment
|
2.68 units on a scale
Standard Deviation 2.87
|
4.00 units on a scale
Standard Deviation 3.32
|
|
Modified Pain Characteristic Questionnaire
Mood Interference Question: Before Treatment
|
2.57 units on a scale
Standard Deviation 3.07
|
3.78 units on a scale
Standard Deviation 2.84
|
|
Modified Pain Characteristic Questionnaire
Mood Interference Question: 24 Hours After Treatme
|
2.42 units on a scale
Standard Deviation 3.06
|
4.19 units on a scale
Standard Deviation 3.04
|
|
Modified Pain Characteristic Questionnaire
Mood Interference Question: 1 Month Post Treatment
|
2.96 units on a scale
Standard Deviation 3.43
|
3.82 units on a scale
Standard Deviation 3.40
|
|
Modified Pain Characteristic Questionnaire
Mood Interference Question: 6 Months Post Treatmen
|
3.18 units on a scale
Standard Deviation 3.26
|
5.71 units on a scale
Standard Deviation 3.68
|
|
Modified Pain Characteristic Questionnaire
Walking Ability Question: Before Treatment
|
0.63 units on a scale
Standard Deviation 1.27
|
1.27 units on a scale
Standard Deviation 2.24
|
|
Modified Pain Characteristic Questionnaire
Walking Ability Question: 24 Hours After Treatment
|
0.54 units on a scale
Standard Deviation 1.33
|
1.24 units on a scale
Standard Deviation 2.37
|
|
Modified Pain Characteristic Questionnaire
Walking Ability Question: 1 Month Post Treatment
|
0.80 units on a scale
Standard Deviation 1.68
|
0.55 units on a scale
Standard Deviation 0.93
|
|
Modified Pain Characteristic Questionnaire
Walking Ability Question: 6 Months Post Treatment
|
0.45 units on a scale
Standard Deviation 1.74
|
0.43 units on a scale
Standard Deviation 1.13
|
|
Modified Pain Characteristic Questionnaire
Normal Work Question: Before Treatment
|
2.53 units on a scale
Standard Deviation 3.08
|
3.49 units on a scale
Standard Deviation 2.81
|
|
Modified Pain Characteristic Questionnaire
Normal Work Question: 24 Hours After Treatment
|
2.21 units on a scale
Standard Deviation 3.02
|
3.63 units on a scale
Standard Deviation 2.97
|
|
Modified Pain Characteristic Questionnaire
Normal Work Question: 1 Month Post Treatment
|
2.52 units on a scale
Standard Deviation 3.14
|
3.45 units on a scale
Standard Deviation 2.94
|
|
Modified Pain Characteristic Questionnaire
Normal Work Question: 6 Months Post Treatment
|
2.59 units on a scale
Standard Deviation 2.77
|
3.71 units on a scale
Standard Deviation 3.50
|
|
Modified Pain Characteristic Questionnaire
Relationships Question: Before Treatment
|
2.00 units on a scale
Standard Deviation 2.87
|
3.47 units on a scale
Standard Deviation 2.92
|
|
Modified Pain Characteristic Questionnaire
Relationships Question: 24 Hours After Treatment
|
1.96 units on a scale
Standard Deviation 2.87
|
3.90 units on a scale
Standard Deviation 3.09
|
|
Modified Pain Characteristic Questionnaire
Relationships Question: 1 Month Post Treatment
|
2.36 units on a scale
Standard Deviation 3.29
|
3.09 units on a scale
Standard Deviation 3.45
|
|
Modified Pain Characteristic Questionnaire
Relationships Question: 6 Months Post Treatment
|
2.05 units on a scale
Standard Deviation 2.87
|
3.86 units on a scale
Standard Deviation 3.98
|
|
Modified Pain Characteristic Questionnaire
Sleep Interference Question: Before Treatment
|
2.29 units on a scale
Standard Deviation 3.09
|
2.68 units on a scale
Standard Deviation 3.11
|
|
Modified Pain Characteristic Questionnaire
Sleep Interfere Question: 24 Hours After Treatment
|
1.89 units on a scale
Standard Deviation 3.03
|
2.85 units on a scale
Standard Deviation 3.22
|
|
Modified Pain Characteristic Questionnaire
Sleep Interferenc Question: 1 Month Post Treatment
|
1.92 units on a scale
Standard Deviation 3.00
|
2.55 units on a scale
Standard Deviation 3.47
|
|
Modified Pain Characteristic Questionnaire
Sleep Interference Question: 6 Months Post Treatme
|
1.55 units on a scale
Standard Deviation 2.32
|
3.14 units on a scale
Standard Deviation 3.93
|
|
Modified Pain Characteristic Questionnaire
Enjoyment Question: Before Treatment
|
2.81 units on a scale
Standard Deviation 3.24
|
3.12 units on a scale
Standard Deviation 2.74
|
|
Modified Pain Characteristic Questionnaire
Enjoyment Question: 24 Hours After Treatment
|
2.58 units on a scale
Standard Deviation 3.29
|
3.34 units on a scale
Standard Deviation 2.89
|
|
Modified Pain Characteristic Questionnaire
Enjoyment Question: 1 Month Post Treatment
|
2.64 units on a scale
Standard Deviation 3.51
|
3.09 units on a scale
Standard Deviation 2.91
|
|
Modified Pain Characteristic Questionnaire
Enjoyment Question: 6 Months Post Treatment
|
3.18 units on a scale
Standard Deviation 3.36
|
4.00 units on a scale
Standard Deviation 4.12
|
SECONDARY outcome
Timeframe: 12 WeeksCompare change in the number of migraine headache days per month reported in Baseline Period Diary vs. Treatment Period Diary vs. Post-Treatment Period Diary.
Outcome measures
| Measure |
Marcaine
n=26 Participants
Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.
|
Saline
n=12 Participants
Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
|
|---|---|---|
|
Migraine Headache Days
Baseline
|
15.0 Migraine headache days per month
Standard Deviation 6.33
|
15.8 Migraine headache days per month
Standard Deviation 7.40
|
|
Migraine Headache Days
Treatment
|
12.3 Migraine headache days per month
Standard Deviation 8.83
|
12.2 Migraine headache days per month
Standard Deviation 9.69
|
|
Migraine Headache Days
Post Treatment
|
10.8 Migraine headache days per month
Standard Deviation 9.22
|
11.3 Migraine headache days per month
Standard Deviation 8.32
|
SECONDARY outcome
Timeframe: 10 WeeksNumber of acute medications used during Treatment period (6 weeks) and Follow-Up (4 weeks) (Group A vs. Group B).
Outcome measures
| Measure |
Marcaine
n=26 Participants
Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.
|
Saline
n=12 Participants
Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
|
|---|---|---|
|
Acute Medications Usage
|
29.3 Number of medications used
Standard Deviation 28.2
|
47.4 Number of medications used
Standard Deviation 54.2
|
SECONDARY outcome
Timeframe: 34 weeksNumber of adverse events over the entire length of study (Group A vs. Group B).
Outcome measures
| Measure |
Marcaine
n=27 Participants
Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.
|
Saline
n=14 Participants
Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
|
|---|---|---|
|
Adverse Events
|
7.67 Number of Adverse Events
Standard Deviation 8.23
|
5.29 Number of Adverse Events
Standard Deviation 7.02
|
SECONDARY outcome
Timeframe: 10 WeeksTotal Headache Impact Test (HIT-6) scores Pre-Treatment at Visit 2 vs. Post-Treatment (following final treatment), and at 1-Month Post-Treatment (Group A vs. Group B). HIT-6 is a series of 6 likert scale questions ranging from 1 to 5 with 1 being never and 5 being always. The HIT-6 answer options are weighted as follows: Never (1) = 6 points each, Rarely (2) = 9 points each, Sometimes (3) = 10 points each, Very often (4) = 11 points each, Always (5) = 13 points each. The total score for the HIT-6 ranges from 36 (subject answers all 6 questions as "Never") to 78 subject answers all 6 questions as "Always"), with higher total scores indicating more impact than lower scores, i.e., headaches cause greater impact on the subject's life.
Outcome measures
| Measure |
Marcaine
n=26 Participants
Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.
|
Saline
n=12 Participants
Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
|
|---|---|---|
|
Headache Impact Test (HIT-6)
Pre-Treatment
|
64.36 units on a scale
Standard Deviation 4.93
|
64 units on a scale
Standard Deviation 3.92
|
|
Headache Impact Test (HIT-6)
Post-Treatment
|
59.85 units on a scale
Standard Deviation 8.33
|
62.5 units on a scale
Standard Deviation 4.96
|
|
Headache Impact Test (HIT-6)
1-Month Post-Treatment
|
59.23 units on a scale
Standard Deviation 8.97
|
61.92 units on a scale
Standard Deviation 5.45
|
SECONDARY outcome
Timeframe: 10 WeeksSatisfaction scores Visit 2 vs. following treatment (Treatment 12) and at 1-Month Post-Treatment (Group A vs. Group B). Satisfaction scores are a likert scale ranging from 1 to 5 with 1 being complete dissatisfaction and 5 being complete satisfaction.
Outcome measures
| Measure |
Marcaine
n=26 Participants
Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.
|
Saline
n=12 Participants
Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
|
|---|---|---|
|
Overall Satisfaction
Visit 2
|
3.52 units on a scale
Standard Deviation 0.75
|
3.00 units on a scale
Standard Deviation 0.89
|
|
Overall Satisfaction
Following treatment (Treatment 12)
|
3.55 units on a scale
Standard Deviation 1.00
|
2.50 units on a scale
Standard Deviation 0.97
|
|
Overall Satisfaction
1-Month Post-Treatment
|
3.57 units on a scale
Standard Deviation 0.99
|
2.64 units on a scale
Standard Deviation 1.12
|
Adverse Events
Marcaine
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Saline
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Marcaine
n=27 participants at risk
Marcaine (Group A) will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.
|
Saline
n=14 participants at risk
Saline (Group B) will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
|
|---|---|---|
|
Cardiac disorders
Pulmonary Embolism Resulting in Death
|
0.00%
0/27 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
Other adverse events
| Measure |
Marcaine
n=27 participants at risk
Marcaine (Group A) will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)
Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.
|
Saline
n=14 participants at risk
Saline (Group B) will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
|
|---|---|---|
|
General disorders
Bad Taste
|
25.9%
7/27 • Number of events 30 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
7.1%
1/14 • Number of events 3 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
33.3%
9/27 • Number of events 9 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
|
Eye disorders
Lacrimation
|
29.6%
8/27 • Number of events 58 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
|
General disorders
Mouth Numbness
|
22.2%
6/27 • Number of events 37 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
0.00%
0/14 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
|
General disorders
Nasal Irritation
|
14.8%
4/27 • Number of events 7 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
21.4%
3/14 • Number of events 6 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
|
General disorders
Dizziness
|
0.00%
0/27 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
14.3%
2/14 • Number of events 5 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
|
Ear and labyrinth disorders
Ear Ringing
|
0.00%
0/27 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
|
General disorders
Light Headedness
|
3.7%
1/27 • Number of events 1 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
14.3%
2/14 • Number of events 3 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
|
General disorders
Sore Throat
|
7.4%
2/27 • Number of events 2 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
14.3%
2/14 • Number of events 2 • Adverse events were collected from the time of signing the informed consent until study exit. The length of study participation was 34 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place