Trial Outcomes & Findings for Chordate System Prophylactic Migraine Clinical Investigation (NCT NCT02243865)
NCT ID: NCT02243865
Last Updated: 2021-11-08
Results Overview
A diary was used where patients added information each day on experienced migraine (yes/no). Baseline was defined as any migraine days from Day -29 until Day -1, i.e. the day before first treatment (Day 1). If full time period for baseline or the post treatment period was not documented, number of migraine days was recalculated with the formula: Number of migraine days = (Number of migraine days x 28) / Number of days observed If data was missing for any patient for more than 14 days during any period of interest, that patient was excluded from analysis. The change from baseline in number of migraine days was calculated as follows: Change = number of migraine days per four weeks for the 3 months post treatment period - number of migraine days per four weeks of the baseline period As the difference between the post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine days.
COMPLETED
NA
87 participants
From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
2021-11-08
Participant Flow
Participant milestones
| Measure |
Chordate System S200 + CT100 (Active) Treatment
Chordate System S200 + control module (CT100), active treatment: 44 subjects
|
Chordate System S200 + CT100 (Placebo Treatment)
Chordate System S200 + control module (CT100), placebo treatment: 38 subjects
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
43
|
|
Overall Study
COMPLETED
|
40
|
38
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Chordate System S200 + CT100 (Active) Treatment
Chordate System S200 + control module (CT100), active treatment: 44 subjects
|
Chordate System S200 + CT100 (Placebo Treatment)
Chordate System S200 + control module (CT100), placebo treatment: 38 subjects
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
Baseline Characteristics
Chordate System Prophylactic Migraine Clinical Investigation
Baseline characteristics by cohort
| Measure |
Chordate System S200 + CT100 (Active Treatment)
n=44 Participants
Chordate System S200 + CT100 (active treatment) is Kinetic Oscillation Stimulation (KOS) treatment with the Chordate System S200 + CT100
|
Chordate System S200 + CT100 (Placebo Treatment)
n=43 Participants
Chordate System S200 + CT100 (placebo treatment), is Placebo treatment with the Chordate System S200 + CT100 without an inflated catheter and without vibrations
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 11.7 • n=93 Participants
|
49.0 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
47.3 years
STANDARD_DEVIATION 11.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Region of Enrollment
Sweden
|
44 participants
n=93 Participants
|
43 participants
n=4 Participants
|
87 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)Population: 44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment. Only patients who completed treatment were included in analysis (see participant flow).
A diary was used where patients added information each day on experienced migraine (yes/no). Baseline was defined as any migraine days from Day -29 until Day -1, i.e. the day before first treatment (Day 1). If full time period for baseline or the post treatment period was not documented, number of migraine days was recalculated with the formula: Number of migraine days = (Number of migraine days x 28) / Number of days observed If data was missing for any patient for more than 14 days during any period of interest, that patient was excluded from analysis. The change from baseline in number of migraine days was calculated as follows: Change = number of migraine days per four weeks for the 3 months post treatment period - number of migraine days per four weeks of the baseline period As the difference between the post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine days.
Outcome measures
| Measure |
Chordate System S200 + CT100 (Active Treatment)
n=40 Participants
Chordate System S200 + CT100 (active treatment): 44 subjects
|
Chordate System S200 + CT100 (Placebo Treatment)
n=38 Participants
Chordate System S200 + CT100 (placebo treatment): 43 subjects
|
|---|---|---|
|
Change From Baseline in Number of Migraine Days Per Four Weeks During the Three Months Post Treatment Investigation Duration
|
-1.5 Migraine days/four weeks
Standard Deviation 3.6
|
-1.3 Migraine days/four weeks
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)Population: 44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint.
A diary was used where patients added information each day on experienced migraine (yes/no). Baseline was defined as any migraine days from Day -29 until Day -1, i.e. the day before first treatment (Day 1). If the full time period for either baseline or post treatment period was not documented number of migraine days was recalculated with the formula: Number of migraine days = (Number of migraine days x 28) / Number of days observed If data was missing for any patient for more than 14 days during any period of interest, that patient was excluded from the analysis of that time period. The change from baseline in number of migraine days was calculated as follows: Change = number of migraine days per four weeks for applicable post treatment period - number of migraine days per four weeks of the baseline period As the difference between applicable post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine days.
Outcome measures
| Measure |
Chordate System S200 + CT100 (Active Treatment)
n=40 Participants
Chordate System S200 + CT100 (active treatment): 44 subjects
|
Chordate System S200 + CT100 (Placebo Treatment)
n=38 Participants
Chordate System S200 + CT100 (placebo treatment): 43 subjects
|
|---|---|---|
|
Change From Baseline in Number of Migraine Days During the 1st, 2nd and 3rd Month and During the Final Four Weeks of the Three Month Post Treatment Investigation Duration
Month 1
|
-1.4 Migraine days/four weeks
Standard Deviation 3.9
|
-1.1 Migraine days/four weeks
Standard Deviation 3.9
|
|
Change From Baseline in Number of Migraine Days During the 1st, 2nd and 3rd Month and During the Final Four Weeks of the Three Month Post Treatment Investigation Duration
Month 2
|
-2.2 Migraine days/four weeks
Standard Deviation 4.0
|
-0.8 Migraine days/four weeks
Standard Deviation 3.5
|
|
Change From Baseline in Number of Migraine Days During the 1st, 2nd and 3rd Month and During the Final Four Weeks of the Three Month Post Treatment Investigation Duration
Month 3
|
-1.4 Migraine days/four weeks
Standard Deviation 4.1
|
-2.2 Migraine days/four weeks
Standard Deviation 3.6
|
|
Change From Baseline in Number of Migraine Days During the 1st, 2nd and 3rd Month and During the Final Four Weeks of the Three Month Post Treatment Investigation Duration
Final 4 weeks
|
-1.1 Migraine days/four weeks
Standard Deviation 4.4
|
-1.7 Migraine days/four weeks
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)Population: 44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint.
"Responder" defined as a patient with 50% or greater decrease in the number of migraine days per four weeks, for the 1st, 2nd and 3rd month post treatment vs baseline
Outcome measures
| Measure |
Chordate System S200 + CT100 (Active Treatment)
n=40 Participants
Chordate System S200 + CT100 (active treatment): 44 subjects
|
Chordate System S200 + CT100 (Placebo Treatment)
n=38 Participants
Chordate System S200 + CT100 (placebo treatment): 43 subjects
|
|---|---|---|
|
Responder Rate
Month 1
|
14 Participants
|
7 Participants
|
|
Responder Rate
Month 2
|
15 Participants
|
10 Participants
|
|
Responder Rate
Month 3
|
12 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: From baseline (day ≥ - 28 days) to visit 4 (day 98, ± 7 days)Population: 44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint.
A diary was used where patients added information on the maximum pain intensity on each day according to a 4-point categorical scale (none, mild, medium, severe). The maximum documented pain intensity for each patient during each post treatment time period was tabulated for the active treatment and placebo groups.
Outcome measures
| Measure |
Chordate System S200 + CT100 (Active Treatment)
n=39 Participants
Chordate System S200 + CT100 (active treatment): 44 subjects
|
Chordate System S200 + CT100 (Placebo Treatment)
n=37 Participants
Chordate System S200 + CT100 (placebo treatment): 43 subjects
|
|---|---|---|
|
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Complete 3 Months · Mild
|
1 Participants
|
1 Participants
|
|
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Month 3 · Mild
|
4 Participants
|
8 Participants
|
|
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Month 3 · Moderate
|
15 Participants
|
14 Participants
|
|
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Month 3 · Severe
|
17 Participants
|
12 Participants
|
|
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Final 4 weeks · Mild
|
5 Participants
|
5 Participants
|
|
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Final 4 weeks · Moderate
|
18 Participants
|
14 Participants
|
|
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Final 4 weeks · Severe
|
13 Participants
|
15 Participants
|
|
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Complete 3 Months · Moderate
|
11 Participants
|
12 Participants
|
|
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Complete 3 Months · Severe
|
27 Participants
|
24 Participants
|
|
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Month 1 · Mild
|
6 Participants
|
5 Participants
|
|
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Month 1 · Moderate
|
13 Participants
|
14 Participants
|
|
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Month 1 · Severe
|
19 Participants
|
17 Participants
|
|
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Month 2 · Mild
|
5 Participants
|
2 Participants
|
|
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Month 2 · Moderate
|
14 Participants
|
17 Participants
|
|
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Month 2 · Severe
|
19 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)Population: 44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint.
A diary was used where patients added information each day on the number of hours with migraine. The median migraine duration in hours per day was determined for each patient, for each post treatment time period. Baseline for each patient was defined as the median number of migraine hours/day from Day -29 until Day -1, i.e. the day before the first treatment (Day 1). The change in median migraine hours/day from baseline, for each defined post treatment time period, was then determined and the mean change is presented. As the differences between applicable post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine hours/day.
Outcome measures
| Measure |
Chordate System S200 + CT100 (Active Treatment)
n=34 Participants
Chordate System S200 + CT100 (active treatment): 44 subjects
|
Chordate System S200 + CT100 (Placebo Treatment)
n=32 Participants
Chordate System S200 + CT100 (placebo treatment): 43 subjects
|
|---|---|---|
|
Mean Change From Baseline in Median Migraine Duration (Hours/Day) During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Month 1
|
-0.7 Hours / day
Standard Deviation 3.3
|
0.1 Hours / day
Standard Deviation 2.5
|
|
Mean Change From Baseline in Median Migraine Duration (Hours/Day) During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Month 2
|
0.2 Hours / day
Standard Deviation 3.9
|
1.3 Hours / day
Standard Deviation 5.0
|
|
Mean Change From Baseline in Median Migraine Duration (Hours/Day) During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Month 3
|
0.6 Hours / day
Standard Deviation 5.1
|
-0.4 Hours / day
Standard Deviation 4.9
|
|
Mean Change From Baseline in Median Migraine Duration (Hours/Day) During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Final 4 weeks
|
1.0 Hours / day
Standard Deviation 5.7
|
0.0 Hours / day
Standard Deviation 4.1
|
|
Mean Change From Baseline in Median Migraine Duration (Hours/Day) During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Complete 3 Months
|
-0.6 Hours / day
Standard Deviation 3.4
|
0.2 Hours / day
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)Population: No statistical analysis was done; only tabular listing. All patients that completed treatment were included.
Outcome measures
| Measure |
Chordate System S200 + CT100 (Active Treatment)
n=44 Participants
Chordate System S200 + CT100 (active treatment): 44 subjects
|
Chordate System S200 + CT100 (Placebo Treatment)
n=43 Participants
Chordate System S200 + CT100 (placebo treatment): 43 subjects
|
|---|---|---|
|
Change From Baseline in Drug Consumption for Acute Treatment During the Three Month Post Treatment Investigation Duration
|
157 Number of medications
|
125 Number of medications
|
SECONDARY outcome
Timeframe: At visit 4 day 98, ± 7 daysPopulation: 44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis.
Patient satisfaction, evaluated by a clinician, was measured using 8-point clinical global impression (CGI) scores on an improvement scale (CGI-I: compared to condition at baseline, how much has changed: 0 = Not assessed, 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse).
Outcome measures
| Measure |
Chordate System S200 + CT100 (Active Treatment)
n=40 Participants
Chordate System S200 + CT100 (active treatment): 44 subjects
|
Chordate System S200 + CT100 (Placebo Treatment)
n=38 Participants
Chordate System S200 + CT100 (placebo treatment): 43 subjects
|
|---|---|---|
|
Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI)
Very much improved
|
3 Participants
|
1 Participants
|
|
Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI)
Much improved
|
10 Participants
|
5 Participants
|
|
Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI)
Minimally improved
|
14 Participants
|
12 Participants
|
|
Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI)
No change
|
10 Participants
|
18 Participants
|
|
Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI)
Minimally worse
|
2 Participants
|
2 Participants
|
|
Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI)
Much worse
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)Population: 44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis. If a patient had missing data for more than 14 days for any of the periods of interest, that period was excluded from the statistical analysis of the applicable endpoint.
Number of Participants with a Change in Disease-specific Quality of Life, as measured by EQ-5D-3L, from Baseline (day 0, visit 2 before first treatment) to End of the Three Month Investigation Duration. EQ-5D-3L uses 5 categorical dimensions - motility, self-care, usual activities, pain/discomfort and anxiety/depression, each classified as improved, no change or worsened.
Outcome measures
| Measure |
Chordate System S200 + CT100 (Active Treatment)
n=39 Participants
Chordate System S200 + CT100 (active treatment): 44 subjects
|
Chordate System S200 + CT100 (Placebo Treatment)
n=38 Participants
Chordate System S200 + CT100 (placebo treatment): 43 subjects
|
|---|---|---|
|
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
Motility · Improved
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
Motility · No change
|
38 Participants
|
38 Participants
|
|
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
Motility · Worsened
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
Self-care · Improved
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
Self-care · No change
|
39 Participants
|
38 Participants
|
|
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
Self-care · Worsened
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
Usual activities · Improved
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
Usual activities · No change
|
37 Participants
|
37 Participants
|
|
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
Usual activities · Worsened
|
2 Participants
|
1 Participants
|
|
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
Pain/Discomfort · Improved
|
4 Participants
|
6 Participants
|
|
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
Pain/Discomfort · No change
|
25 Participants
|
22 Participants
|
|
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
Pain/Discomfort · Worsened
|
10 Participants
|
10 Participants
|
|
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
Anxiety/Depression · Improved
|
3 Participants
|
4 Participants
|
|
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
Anxiety/Depression · No change
|
30 Participants
|
31 Participants
|
|
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
Anxiety/Depression · Worsened
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)Population: 44 patients were allocated to active treatment and 43 to placebo. Out of these 40 patients completed the active treatment and 38 patients completed placebo treatment (see participant flow). Only patients who completed treatment were included in analysis.
Disease-specific quality of life, as measured by EQ-VAS, at baseline (day 0, visit 2 before first treatment) and at end of the three month study duration after treatment. The EQ VAS is a standard vertical 20 cm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a score from 0-100, where a higher score indicates greater pain intensity.
Outcome measures
| Measure |
Chordate System S200 + CT100 (Active Treatment)
n=40 Participants
Chordate System S200 + CT100 (active treatment): 44 subjects
|
Chordate System S200 + CT100 (Placebo Treatment)
n=38 Participants
Chordate System S200 + CT100 (placebo treatment): 43 subjects
|
|---|---|---|
|
Disease-specific Quality of Life (VAS Pain Scale) From Baseline to End of the Three Month Study Duration
VAS Pain score at visit 2
|
79.7 score on a scale
Standard Deviation 15.0
|
80.6 score on a scale
Standard Deviation 15.1
|
|
Disease-specific Quality of Life (VAS Pain Scale) From Baseline to End of the Three Month Study Duration
VAS pain score at visit 4
|
77.8 score on a scale
Standard Deviation 14.5
|
79.8 score on a scale
Standard Deviation 15.0
|
Adverse Events
Chordate System S200 + CT100 (Active Treatment)
Chordate System S200 + CT100 (Placebo Treatment)
Serious adverse events
| Measure |
Chordate System S200 + CT100 (Active Treatment)
n=44 participants at risk
Chordate System S200 + CT100 (active treatment): 44 subjects
|
Chordate System S200 + CT100 (Placebo Treatment)
n=43 participants at risk
Chordate System S200 + CT100 (placebo treatment): 43 subjects
|
|---|---|---|
|
Eye disorders
Laminar hole of the macula
|
2.3%
1/44 • Number of events 1 • Adverse Event data was collected during both the treatment period and the follow-up period until End of Study, an average of 3 months
|
0.00%
0/43 • Adverse Event data was collected during both the treatment period and the follow-up period until End of Study, an average of 3 months
|
Other adverse events
| Measure |
Chordate System S200 + CT100 (Active Treatment)
n=44 participants at risk
Chordate System S200 + CT100 (active treatment): 44 subjects
|
Chordate System S200 + CT100 (Placebo Treatment)
n=43 participants at risk
Chordate System S200 + CT100 (placebo treatment): 43 subjects
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Increased nasal secretion
|
29.5%
13/44 • Adverse Event data was collected during both the treatment period and the follow-up period until End of Study, an average of 3 months
|
7.0%
3/43 • Adverse Event data was collected during both the treatment period and the follow-up period until End of Study, an average of 3 months
|
|
Eye disorders
Increased tear secretion
|
75.0%
33/44 • Adverse Event data was collected during both the treatment period and the follow-up period until End of Study, an average of 3 months
|
16.3%
7/43 • Adverse Event data was collected during both the treatment period and the follow-up period until End of Study, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Mild burning sensation
|
31.8%
14/44 • Adverse Event data was collected during both the treatment period and the follow-up period until End of Study, an average of 3 months
|
7.0%
3/43 • Adverse Event data was collected during both the treatment period and the follow-up period until End of Study, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Paraesthesia of the lip
|
31.8%
14/44 • Adverse Event data was collected during both the treatment period and the follow-up period until End of Study, an average of 3 months
|
9.3%
4/43 • Adverse Event data was collected during both the treatment period and the follow-up period until End of Study, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Slight discomfort
|
52.3%
23/44 • Adverse Event data was collected during both the treatment period and the follow-up period until End of Study, an average of 3 months
|
37.2%
16/43 • Adverse Event data was collected during both the treatment period and the follow-up period until End of Study, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Slight pain
|
25.0%
11/44 • Adverse Event data was collected during both the treatment period and the follow-up period until End of Study, an average of 3 months
|
0.00%
0/43 • Adverse Event data was collected during both the treatment period and the follow-up period until End of Study, an average of 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
15.9%
7/44 • Adverse Event data was collected during both the treatment period and the follow-up period until End of Study, an average of 3 months
|
4.7%
2/43 • Adverse Event data was collected during both the treatment period and the follow-up period until End of Study, an average of 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place