Trial Outcomes & Findings for Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches (NCT NCT04066023)
NCT ID: NCT04066023
Last Updated: 2022-06-14
Results Overview
Pain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
42 participants
Primary outcome timeframe
15 minutes
Results posted on
2022-06-14
Participant Flow
A total of 51 subjects were screened at 12 investigative sites. Of the 51 screened subjects, 42 were randomized to receive either C213 1.9 mg (17 subjects), C213 3.8 mg (13), or placebo (12) and had up to 48 weeks from randomization to treat a qualifying headache. 23 subjects applied the study patch and entered the Treatment Period.
Participant milestones
| Measure |
Placebo
Placebo microneedle system administered as two placebo patches
Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm\^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.
|
C213 1.9 mg
C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
C213 3.8mg
C213 3.8 mg administered as two 1.9 mg patches
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
17
|
13
|
|
Overall Study
COMPLETED
|
9
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Placebo microneedle system administered as two placebo patches
Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm\^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.
|
C213 1.9 mg
C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
C213 3.8mg
C213 3.8 mg administered as two 1.9 mg patches
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Sponsor decision
|
3
|
6
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
|
Overall Study
Noncompliance
|
0
|
1
|
1
|
Baseline Characteristics
Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches
Baseline characteristics by cohort
| Measure |
Placebo
n=9 Participants
Placebo microneedle system administered as two placebo patches
Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm\^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.
|
C213 1.9 mg
n=9 Participants
C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
C213 3.8mg
n=5 Participants
C213 3.8 mg administered as two 1.9 mg patches
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 11.82 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 12.75 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 12.76 • n=5 Participants
|
50.1 years
STANDARD_DEVIATION 12.12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
5 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Weight
|
94.9 kilograms
STANDARD_DEVIATION 9.76 • n=5 Participants
|
85.3 kilograms
STANDARD_DEVIATION 13.36 • n=7 Participants
|
82.6 kilograms
STANDARD_DEVIATION 14.88 • n=5 Participants
|
88.4 kilograms
STANDARD_DEVIATION 12.98 • n=4 Participants
|
|
Height
|
180.0 centimeters
STANDARD_DEVIATION 8.92 • n=5 Participants
|
174.3 centimeters
STANDARD_DEVIATION 9.14 • n=7 Participants
|
173.7 centimeters
STANDARD_DEVIATION 7.53 • n=5 Participants
|
176.5 centimeters
STANDARD_DEVIATION 8.82 • n=4 Participants
|
|
BMI
|
29.4 kg/m^2
STANDARD_DEVIATION 3.51 • n=5 Participants
|
28.4 kg/m^2
STANDARD_DEVIATION 4.54 • n=7 Participants
|
27.2 kg/m^2
STANDARD_DEVIATION 3.27 • n=5 Participants
|
28.6 kg/m^2
STANDARD_DEVIATION 3.79 • n=4 Participants
|
|
Nicotine User
Never
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Nicotine User
Past
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Nicotine User
Current
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Current Alcohol User
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 15 minutesPopulation: Modified Intent-to-treat Population
Pain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo microneedle system administered as two placebo patches
Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm\^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.
|
C213 1.9 mg
n=9 Participants
C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
C213 3.8mg
n=5 Participants
C213 3.8 mg administered as two 1.9 mg patches
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
|---|---|---|---|
|
Percentage of Subjects Who Achieve Pain Relief
|
3 Participants
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 15 minutes to 60 minutesPopulation: Modified Intent-to-treat Population
Sustained pain relief requires a pain rating of mild or none at each timepoint from 15 minutes to 60 minutes without the use of acute rescue medication.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo microneedle system administered as two placebo patches
Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm\^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.
|
C213 1.9 mg
n=9 Participants
C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
C213 3.8mg
n=5 Participants
C213 3.8 mg administered as two 1.9 mg patches
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
|---|---|---|---|
|
Percentage of Subjects Who Achieve Sustained Pain Relief
|
3 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 5 minutesPopulation: Modified Intent-to-treat Population
Pain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo microneedle system administered as two placebo patches
Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm\^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.
|
C213 1.9 mg
n=9 Participants
C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
C213 3.8mg
n=5 Participants
C213 3.8 mg administered as two 1.9 mg patches
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
|---|---|---|---|
|
Percentage of Subjects That Achieve Pain Relief
|
0 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 5 minutes to 60 minutesPopulation: Modified Intent-to-treat Population
Sustained pain relief requires a pain rating of mild or none at each timepoint within the time frame without the use of acute rescue medication.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo microneedle system administered as two placebo patches
Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm\^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.
|
C213 1.9 mg
n=9 Participants
C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
C213 3.8mg
n=5 Participants
C213 3.8 mg administered as two 1.9 mg patches
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
|---|---|---|---|
|
Percentage of Subjects That Achieve Sustained Pain Relief
|
0 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 10 minutesPopulation: Modified Intent-to-treat Population
Pain freedom is defined by a decrease in pain from severe to none without the use of acute rescue medication.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo microneedle system administered as two placebo patches
Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm\^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.
|
C213 1.9 mg
n=9 Participants
C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
C213 3.8mg
n=5 Participants
C213 3.8 mg administered as two 1.9 mg patches
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
|---|---|---|---|
|
Percentage of Subjects That Achieve Pain Freedom
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 15 to 60 minutesPopulation: Modified Intent-to-treat Population
Sustained pain freedom requires a pain rating of none at each timepoint within the time frame without the use of acute rescue medication.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo microneedle system administered as two placebo patches
Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm\^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.
|
C213 1.9 mg
n=9 Participants
C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
C213 3.8mg
n=5 Participants
C213 3.8 mg administered as two 1.9 mg patches
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
|---|---|---|---|
|
Percentage of Subjects That Achieve Sustained Pain Freedom
|
1 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: within 20 minutesPopulation: Modified Intent-to-treat Population
Whether or not subjects were able to perform their usual daily activities was assessed by subject responses (Yes or No) in the electronic diary (eDiary) to the question, "Do you feel able to perform your usual daily activities?" If a subject responded "Yes" but had used a rescue medication, the subject was considered as not being able to perform the usual daily activities.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo microneedle system administered as two placebo patches
Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm\^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.
|
C213 1.9 mg
n=9 Participants
C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
C213 3.8mg
n=5 Participants
C213 3.8 mg administered as two 1.9 mg patches
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
|---|---|---|---|
|
Percentage of Subjects Able to Perform Their Usual Daily Activities as Assessed by the Subject
|
2 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 10 minutesPain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo microneedle system administered as two placebo patches
Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm\^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.
|
C213 1.9 mg
n=9 Participants
C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
C213 3.8mg
n=5 Participants
C213 3.8 mg administered as two 1.9 mg patches
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
|---|---|---|---|
|
Percentage of Subjects That Achieve Pain Relief
|
2 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 20 minutesPain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo microneedle system administered as two placebo patches
Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm\^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.
|
C213 1.9 mg
n=9 Participants
C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
C213 3.8mg
n=5 Participants
C213 3.8 mg administered as two 1.9 mg patches
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
|---|---|---|---|
|
Percentage of Subjects That Achieve Pain Relief
|
4 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 10 minutes to 60 minutesPopulation: Modified Intent-to-treat Population
Sustained pain relief requires a pain rating of mild or none at each timepoint within the time frame without the use of acute rescue medication.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo microneedle system administered as two placebo patches
Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm\^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.
|
C213 1.9 mg
n=9 Participants
C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
C213 3.8mg
n=5 Participants
C213 3.8 mg administered as two 1.9 mg patches
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
|---|---|---|---|
|
Percentage of Subjects That Achieve Sustained Pain Relief
|
2 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 20 minutesPopulation: Modified Intent-to-treat Population
Pain freedom is defined by a decrease in pain from severe to none without the use of acute rescue medication.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo microneedle system administered as two placebo patches
Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm\^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.
|
C213 1.9 mg
n=9 Participants
C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
C213 3.8mg
n=5 Participants
C213 3.8 mg administered as two 1.9 mg patches
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
|---|---|---|---|
|
Percentage of Subjects That Achieve Pain Freedom
|
2 Participants
|
3 Participants
|
3 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
C213 1.9 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
C213 3.8mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=9 participants at risk
Placebo microneedle system administered as two placebo patches
Placebo: The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm\^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.
|
C213 1.9 mg
n=9 participants at risk
C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
C213 3.8mg
n=7 participants at risk
C213 3.8 mg administered as two 1.9 mg patches
C213 Microneedle System: The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm\^2 array) is attached to a 5 cm\^2 adhesive patch.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Sunburn
|
11.1%
1/9 • Number of events 1 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
0.00%
0/9 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
0.00%
0/7 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
|
General disorders
Application site erythema
|
11.1%
1/9 • Number of events 1 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
22.2%
2/9 • Number of events 2 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
0.00%
0/7 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
|
General disorders
Application site oedema
|
11.1%
1/9 • Number of events 1 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
0.00%
0/9 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
0.00%
0/7 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
|
General disorders
Application site bruise
|
0.00%
0/9 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
11.1%
1/9 • Number of events 1 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
0.00%
0/7 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/9 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
11.1%
1/9 • Number of events 1 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
14.3%
1/7 • Number of events 1 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/9 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
11.1%
1/9 • Number of events 1 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
0.00%
0/7 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/9 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
0.00%
0/9 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
14.3%
1/7 • Number of events 1 • Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks
|
Additional Information
Don Kellerman, Sr. VP, Clinical Development and Medical Affairs
Zosano Pharma Corporation
Phone: +1 (510) 745-4004
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60