Trial Outcomes & Findings for Study to Assess Efficacy and Safety of HP3070 in Subjects Diagnosed With Schizophrenia. (NCT NCT02876900)
NCT ID: NCT02876900
Last Updated: 2020-10-22
Results Overview
To evaluate efficacy and safety of HP-3070 compared with placebo for the treatment of schizophrenia as evaluated by Positive and Negative Syndrome Scale (PANSS) total score. The PANSS total score is the sum of all 30 items (7 positive items, 7 negative items, and 16 general psychopathology items). For each item, severity was rated on an anchored 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. If one or more items are missing at a given assessment, the total score is set to missing. Total score ranges from 30 to 210. Score indicates severity of the disease, i.e. low score = low severity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
617 participants
Primary outcome timeframe
6 weeks
Results posted on
2020-10-22
Participant Flow
Participant milestones
| Measure |
Low Dose Asenapine Maleate Patch
Low dose asenapine maleate, transdermal patches will be compared against placebo patches.
Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch.
Placebo: Evaluate Low Dose versus Placebo.
|
High Dose Asenapine Maleate Patch
High dose asenapine maleate, transdermal patches will be compared against placebo patches.
High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch
Placebo: Evaluate High Dose versus Placebo.
|
Placebo Patch
Placebo transdermal patch
|
|---|---|---|---|
|
Overall Study
STARTED
|
205
|
206
|
206
|
|
Overall Study
COMPLETED
|
166
|
158
|
162
|
|
Overall Study
NOT COMPLETED
|
39
|
48
|
44
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
Baseline characteristics by cohort
| Measure |
Low Dose Asenapine Maleate Patch
n=204 Participants
Low dose asenapine maleate, transdermal patches will be compared against placebo patches.
Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch
Placebo: The study will evaluate placebo transdermal patch.
|
High Dose Asenapine Maleate Patch
n=206 Participants
High dose asenapine maleate, transdermal patches will be compared against placebo patches.
High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch
Placebo: The study will evaluate placebo transdermal patch.
|
Placebo Patch
n=206 Participants
Placebo transdermal patch
|
Total
n=616 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<55
|
168 Participants
n=204 Participants
|
172 Participants
n=206 Participants
|
171 Participants
n=206 Participants
|
511 Participants
n=616 Participants
|
|
Age, Customized
>=55
|
36 Participants
n=204 Participants
|
34 Participants
n=206 Participants
|
35 Participants
n=206 Participants
|
105 Participants
n=616 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=204 Participants
|
95 Participants
n=206 Participants
|
75 Participants
n=206 Participants
|
243 Participants
n=616 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=204 Participants
|
111 Participants
n=206 Participants
|
131 Participants
n=206 Participants
|
373 Participants
n=616 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=204 Participants
|
5 Participants
n=206 Participants
|
1 Participants
n=206 Participants
|
16 Participants
n=616 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
194 Participants
n=204 Participants
|
201 Participants
n=206 Participants
|
205 Participants
n=206 Participants
|
600 Participants
n=616 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=204 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=616 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=204 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
1 Participants
n=206 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
0 Participants
n=206 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
1 Participants
n=616 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=204 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
0 Participants
n=206 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
0 Participants
n=206 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
0 Participants
n=616 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=204 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
0 Participants
n=206 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
0 Participants
n=206 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
0 Participants
n=616 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
|
Race (NIH/OMB)
Black or African American
|
47 Participants
n=204 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
45 Participants
n=206 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
54 Participants
n=206 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
146 Participants
n=616 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
|
Race (NIH/OMB)
White
|
157 Participants
n=204 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
159 Participants
n=206 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
152 Participants
n=206 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
468 Participants
n=616 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=204 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
0 Participants
n=206 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
0 Participants
n=206 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
0 Participants
n=616 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=204 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
1 Participants
n=206 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
0 Participants
n=206 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
1 Participants
n=616 Participants • A total of 616 subjects were randomized in the study and were included in the ITT analysis set. For Race, a subject could select more than one race in the case report form.
|
|
Region of Enrollment
United States
|
61 participants
n=204 Participants
|
62 participants
n=206 Participants
|
62 participants
n=206 Participants
|
185 participants
n=616 Participants
|
|
Region of Enrollment
Russia
|
60 participants
n=204 Participants
|
60 participants
n=206 Participants
|
60 participants
n=206 Participants
|
180 participants
n=616 Participants
|
|
Region of Enrollment
Bulgaria
|
29 participants
n=204 Participants
|
30 participants
n=206 Participants
|
29 participants
n=206 Participants
|
88 participants
n=616 Participants
|
|
Region of Enrollment
Ukraine
|
35 participants
n=204 Participants
|
35 participants
n=206 Participants
|
36 participants
n=206 Participants
|
106 participants
n=616 Participants
|
|
Region of Enrollment
Serbia
|
19 participants
n=204 Participants
|
19 participants
n=206 Participants
|
19 participants
n=206 Participants
|
57 participants
n=616 Participants
|
|
Height
|
172.5 cm
STANDARD_DEVIATION 9.08 • n=204 Participants
|
171.8 cm
STANDARD_DEVIATION 9.09 • n=206 Participants
|
171.8 cm
STANDARD_DEVIATION 9.16 • n=206 Participants
|
172.0 cm
STANDARD_DEVIATION 9.10 • n=616 Participants
|
|
BMI
|
26.591 kg/m^2
STANDARD_DEVIATION 5.1151 • n=204 Participants
|
26.240 kg/m^2
STANDARD_DEVIATION 4.7834 • n=206 Participants
|
25.925 kg/m^2
STANDARD_DEVIATION 4.8602 • n=206 Participants
|
26.251 kg/m^2
STANDARD_DEVIATION 4.9205 • n=616 Participants
|
|
PANSS total score
<90
|
45 Participants
n=204 Participants • Safety Analysis Set = 614 subj who received double-blind medication. PANSS total score is sum of all 30 items (7 positive items, 7 negative items \& 16 general psychopathology items). For each item, severity rated on an anchored 7-point scale; score of 1=absence of symptoms, score of 7=extremely severe symptoms. Total score ranges from 30 to 210.
|
53 Participants
n=204 Participants • Safety Analysis Set = 614 subj who received double-blind medication. PANSS total score is sum of all 30 items (7 positive items, 7 negative items \& 16 general psychopathology items). For each item, severity rated on an anchored 7-point scale; score of 1=absence of symptoms, score of 7=extremely severe symptoms. Total score ranges from 30 to 210.
|
54 Participants
n=206 Participants • Safety Analysis Set = 614 subj who received double-blind medication. PANSS total score is sum of all 30 items (7 positive items, 7 negative items \& 16 general psychopathology items). For each item, severity rated on an anchored 7-point scale; score of 1=absence of symptoms, score of 7=extremely severe symptoms. Total score ranges from 30 to 210.
|
152 Participants
n=614 Participants • Safety Analysis Set = 614 subj who received double-blind medication. PANSS total score is sum of all 30 items (7 positive items, 7 negative items \& 16 general psychopathology items). For each item, severity rated on an anchored 7-point scale; score of 1=absence of symptoms, score of 7=extremely severe symptoms. Total score ranges from 30 to 210.
|
|
PANSS total score
>=90
|
159 Participants
n=204 Participants • Safety Analysis Set = 614 subj who received double-blind medication. PANSS total score is sum of all 30 items (7 positive items, 7 negative items \& 16 general psychopathology items). For each item, severity rated on an anchored 7-point scale; score of 1=absence of symptoms, score of 7=extremely severe symptoms. Total score ranges from 30 to 210.
|
151 Participants
n=204 Participants • Safety Analysis Set = 614 subj who received double-blind medication. PANSS total score is sum of all 30 items (7 positive items, 7 negative items \& 16 general psychopathology items). For each item, severity rated on an anchored 7-point scale; score of 1=absence of symptoms, score of 7=extremely severe symptoms. Total score ranges from 30 to 210.
|
152 Participants
n=206 Participants • Safety Analysis Set = 614 subj who received double-blind medication. PANSS total score is sum of all 30 items (7 positive items, 7 negative items \& 16 general psychopathology items). For each item, severity rated on an anchored 7-point scale; score of 1=absence of symptoms, score of 7=extremely severe symptoms. Total score ranges from 30 to 210.
|
462 Participants
n=614 Participants • Safety Analysis Set = 614 subj who received double-blind medication. PANSS total score is sum of all 30 items (7 positive items, 7 negative items \& 16 general psychopathology items). For each item, severity rated on an anchored 7-point scale; score of 1=absence of symptoms, score of 7=extremely severe symptoms. Total score ranges from 30 to 210.
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Results are from the full analysis set (FAS) which includes all randomized participants who had at least 1 patch of double-blind study medication applied and who have a baseline PANSS total score and at least 1 post baseline assessment of the primary efficacy measure (PANSS total score) and completed the study.
To evaluate efficacy and safety of HP-3070 compared with placebo for the treatment of schizophrenia as evaluated by Positive and Negative Syndrome Scale (PANSS) total score. The PANSS total score is the sum of all 30 items (7 positive items, 7 negative items, and 16 general psychopathology items). For each item, severity was rated on an anchored 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. If one or more items are missing at a given assessment, the total score is set to missing. Total score ranges from 30 to 210. Score indicates severity of the disease, i.e. low score = low severity.
Outcome measures
| Measure |
Low Dose Asenapine Maleate Patch
n=201 Participants
Low dose asenapine maleate, transdermal patches will be compared against placebo patches.
Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch
Placebo: The study will evaluate placebo transdermal patch.
|
High Dose Asenapine Maleate Patch
n=203 Participants
High dose asenapine maleate, transdermal patches will be compared against placebo patches.
High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch
Placebo: The study will evaluate placebo transdermal patch.
|
Placebo Patch
n=203 Participants
Placebo transdermal patch
|
|---|---|---|---|
|
Evaluate Efficacy and Safety of Asenapine Maleate Patches Compared With Placebo Patches in Subjects Diagnosed With Schizophrenia as Measured Using the Syndrome Scale (PANSS) Total Score: Change From Baseline to Week 6.
|
-22.1 score on a scale
Standard Error 1.158
|
-20.4 score on a scale
Standard Error 1.162
|
-15.5 score on a scale
Standard Error 1.166
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Results are from the full analysis set (FAS) which includes all randomized participants who had at least 1 patch of double-blind study medication applied and who have a baseline PANSS total score and at least 1 post baseline assessment of the primary efficacy measure (PANSS total score) and completed the study.
To evaluate efficacy and safety of HP-3070 compared with placebo for the treatment of schizophrenia as evaluated by the Clinical Global Impression - Severity of Illness Scale. The severity of illness for each participant was rated using the CGI-S. The rater or Investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?". Response choices included: 0 = not assessed; 1 = normal, not at all ill, 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Outcome measures
| Measure |
Low Dose Asenapine Maleate Patch
n=201 Participants
Low dose asenapine maleate, transdermal patches will be compared against placebo patches.
Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch
Placebo: The study will evaluate placebo transdermal patch.
|
High Dose Asenapine Maleate Patch
n=203 Participants
High dose asenapine maleate, transdermal patches will be compared against placebo patches.
High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch
Placebo: The study will evaluate placebo transdermal patch.
|
Placebo Patch
n=203 Participants
Placebo transdermal patch
|
|---|---|---|---|
|
Evaluate Efficacy and Safety of Asenapine Maleate Patches Compared With Placebo Patches in Subjects Diagnosed With Schizophrenia as Measured Using the Clinical Global Impression - Severity of Illness Scale: Change From Baseline to Week 6.
|
-1.3 score on a scale
Standard Deviation 0.90
|
-1.2 score on a scale
Standard Deviation 0.96
|
-0.9 score on a scale
Standard Deviation 0.93
|
Adverse Events
Low Dose Asenapine Maleate Patch
Serious events: 3 serious events
Other events: 75 other events
Deaths: 0 deaths
High Dose Asenapine Maleate Patch
Serious events: 2 serious events
Other events: 78 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose Asenapine Maleate Patch
n=204 participants at risk
Low dose asenapine maleate, transdermal patches will be compared against placebo patches.
Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch
Placebo: The study will evaluate placebo transdermal patch.
|
High Dose Asenapine Maleate Patch
n=204 participants at risk
High dose asenapine maleate, transdermal patches will be compared against placebo patches.
High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch
Placebo: The study will evaluate placebo transdermal patch.
|
Placebo
n=206 participants at risk
Placebo transdermal patch
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/204 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
0.00%
0/204 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
0.49%
1/206 • Number of events 1 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/204 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
0.00%
0/204 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
0.49%
1/206 • Number of events 1 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.49%
1/204 • Number of events 1 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
0.00%
0/204 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
0.00%
0/206 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer hemorrhage
|
0.00%
0/204 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
0.49%
1/204 • Number of events 1 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
0.00%
0/206 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
|
Psychiatric disorders
Schizophrenia
|
0.98%
2/204 • Number of events 2 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
0.49%
1/204 • Number of events 1 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
0.97%
2/206 • Number of events 2 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
Other adverse events
| Measure |
Low Dose Asenapine Maleate Patch
n=204 participants at risk
Low dose asenapine maleate, transdermal patches will be compared against placebo patches.
Low Dose Asenapine maleate transdermal patch: The study will evaluate low dose Asenapine maleate transdermal patch
Placebo: The study will evaluate placebo transdermal patch.
|
High Dose Asenapine Maleate Patch
n=204 participants at risk
High dose asenapine maleate, transdermal patches will be compared against placebo patches.
High Dose Asenapine maleate transdermal patch: The study will evaluate high dose Asenapine maleate transdermal patch
Placebo: The study will evaluate placebo transdermal patch.
|
Placebo
n=206 participants at risk
Placebo transdermal patch
|
|---|---|---|---|
|
Investigations
Weight increased
|
3.9%
8/204 • Number of events 8 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
5.9%
12/204 • Number of events 12 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
1.9%
4/206 • Number of events 4 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
|
Nervous system disorders
Headache
|
8.8%
18/204 • Number of events 23 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
9.3%
19/204 • Number of events 21 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
6.3%
13/206 • Number of events 13 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
|
Nervous system disorders
Extrapyramidal disorder
|
6.4%
13/204 • Number of events 16 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
9.3%
19/204 • Number of events 22 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
1.5%
3/206 • Number of events 4 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
|
General disorders
Application site erythema
|
9.3%
19/204 • Number of events 105 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
9.8%
20/204 • Number of events 57 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
1.5%
3/206 • Number of events 14 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
|
Gastrointestinal disorders
Constipation
|
5.4%
11/204 • Number of events 12 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
4.4%
9/204 • Number of events 11 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
4.4%
9/206 • Number of events 10 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
|
Psychiatric disorders
Insomnia
|
7.4%
15/204 • Number of events 21 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
6.9%
14/204 • Number of events 16 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
11.2%
23/206 • Number of events 28 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
|
Psychiatric disorders
Anxiety
|
4.9%
10/204 • Number of events 14 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
5.4%
11/204 • Number of events 13 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
6.3%
13/206 • Number of events 19 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
|
Psychiatric disorders
Agitation
|
2.5%
5/204 • Number of events 5 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
2.9%
6/204 • Number of events 7 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
5.3%
11/206 • Number of events 14 • From date of first dose of doubleblind (DB) study medication (Day 1) through the 30 day follow-up period, approximately 72 days.
The safety analysis set included all participants who had at least 1 patch of double-blind study medication applied and who have at least 1 post dose safety measurement during the double-blind treatment period.
|
Additional Information
George Harb, MD, MPH - Executive Director, Clinical Development
Noven Pharmaceuticals
Phone: 1-551-233-2656
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place