Trial Outcomes & Findings for Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern (NCT NCT03478982)
NCT ID: NCT03478982
Last Updated: 2021-02-03
Results Overview
Percentage of participants with onset of a predictable seizure through 2 minutes post dosing with study drug and no recurrence of seizure activity within 2 hours were reported for each treatment group based on clinical observation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
156 participants
Primary outcome timeframe
2 hours post-dosing on dosing day
Results posted on
2021-02-03
Participant Flow
The study started to enroll participants in March 2018 and concluded in January 2020.
Participant Flow refers to Enrolled Population.
Participant milestones
| Measure |
Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg)
Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Placebo
Participants received a single dose of placebo matching to alprazolam as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Staccato Alprazolam 1.0 mg
Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Staccato Alprazolam 2.0 mg
Participants received a single dose of alprazolam 2.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
50
|
47
|
48
|
|
Overall Study
Enrolled Participants But Not Treated
|
3
|
10
|
9
|
10
|
|
Overall Study
Intent-to-treat (ITT) Population
|
8
|
40
|
38
|
38
|
|
Overall Study
COMPLETED
|
11
|
50
|
47
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern
Baseline characteristics by cohort
| Measure |
Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg)
n=8 Participants
Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Placebo
n=40 Participants
Participants received a single dose of placebo matching to alprazolam as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Staccato Alprazolam 1.0 mg
n=38 Participants
Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Staccato Alprazolam 2.0 mg
n=38 Participants
Participants received a single dose of alprazolam 2.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Total Title
n=124 Participants
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 14.51 • n=5 Participants
|
33.1 years
STANDARD_DEVIATION 9.80 • n=7 Participants
|
34.8 years
STANDARD_DEVIATION 11.18 • n=5 Participants
|
33.5 years
STANDARD_DEVIATION 11.74 • n=4 Participants
|
34.7 years
STANDARD_DEVIATION 11.60 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian / Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Declined to Answer
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 hours post-dosing on dosing dayPopulation: The Modified Intent-to-treat (mITT) population consisted of all participants who had a seizure event, received study drug, and had at least one evaluation after study drug administration.
Percentage of participants with onset of a predictable seizure through 2 minutes post dosing with study drug and no recurrence of seizure activity within 2 hours were reported for each treatment group based on clinical observation.
Outcome measures
| Measure |
Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg)
n=8 Participants
Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Placebo
n=40 Participants
Participants received a single dose of placebo matching to alprazolam as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Staccato Alprazolam 1.0 mg
n=38 Participants
Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Staccato Alprazolam 2.0 mg
n=38 Participants
Participants received a single dose of alprazolam 2.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
|---|---|---|---|---|
|
Percentage of Participants in Each Treatment Group Achieving Seizure Activity Cessation Within 2 Minutes and no Recurrent Seizure Within 2 Hours
|
62.5 percentage of participants
|
42.5 percentage of participants
|
65.8 percentage of participants
|
65.8 percentage of participants
|
SECONDARY outcome
Timeframe: 6 hours post-dosing on dosing dayPopulation: The mITT population consisted of all participants who had a seizure event, received study drug, and had at least one evaluation after study drug administration.
Severity of on study seizure episode compared to previously experienced seizures was assessed with Seizure Episode Severity Scale. It is a 5-point scale with range from 1 to 5, where 1 indicates much worse than and 5 indicates much better than.
Outcome measures
| Measure |
Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg)
n=8 Participants
Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Placebo
n=40 Participants
Participants received a single dose of placebo matching to alprazolam as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Staccato Alprazolam 1.0 mg
n=38 Participants
Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Staccato Alprazolam 2.0 mg
n=38 Participants
Participants received a single dose of alprazolam 2.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
|---|---|---|---|---|
|
Percentage of Participants With Seizure Episode Severity Assessed by Seizure Episode Severity Scale
Much worse than
|
0 percentage of participants
|
2.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Seizure Episode Severity Assessed by Seizure Episode Severity Scale
Worse than
|
0 percentage of participants
|
5.0 percentage of participants
|
2.6 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Seizure Episode Severity Assessed by Seizure Episode Severity Scale
Same as
|
12.5 percentage of participants
|
42.5 percentage of participants
|
57.9 percentage of participants
|
55.3 percentage of participants
|
|
Percentage of Participants With Seizure Episode Severity Assessed by Seizure Episode Severity Scale
Better than
|
50.0 percentage of participants
|
35.0 percentage of participants
|
18.4 percentage of participants
|
28.9 percentage of participants
|
|
Percentage of Participants With Seizure Episode Severity Assessed by Seizure Episode Severity Scale
Much better than
|
25.0 percentage of participants
|
7.5 percentage of participants
|
15.8 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Seizure Episode Severity Assessed by Seizure Episode Severity Scale
Not done
|
12.5 percentage of participants
|
7.5 percentage of participants
|
5.3 percentage of participants
|
5.3 percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours post-dosing on dosing dayPopulation: The mITT population consisted of all participants who had a seizure event, received study drug, and had at least one evaluation after study drug administration.
Percentage of participants with use of rescue medication to stop a seizure episode at the discretion of the principal investigator were reported.
Outcome measures
| Measure |
Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg)
n=8 Participants
Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Placebo
n=40 Participants
Participants received a single dose of placebo matching to alprazolam as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Staccato Alprazolam 1.0 mg
n=38 Participants
Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Staccato Alprazolam 2.0 mg
n=38 Participants
Participants received a single dose of alprazolam 2.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
|---|---|---|---|---|
|
Percentage of Participants With Use of Rescue Medication
|
0 percentage of participants
|
7.5 percentage of participants
|
15.8 percentage of participants
|
7.9 percentage of participants
|
SECONDARY outcome
Timeframe: 24 hours post-dosing on dosing dayPopulation: The mITT population consisted of all participants who had a seizure event, received study drug, and had at least one evaluation after study drug administration.
Percentage of participants who had seizures that evolved to a complex partial seizure and/or a generalized tonic-clonic seizure were reported.
Outcome measures
| Measure |
Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg)
n=8 Participants
Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Placebo
n=40 Participants
Participants received a single dose of placebo matching to alprazolam as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Staccato Alprazolam 1.0 mg
n=38 Participants
Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Staccato Alprazolam 2.0 mg
n=38 Participants
Participants received a single dose of alprazolam 2.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
|---|---|---|---|---|
|
Percentage of Participants With Secondary Generalization (Evolution to a Complex Partial Seizure and/or a Generalized Tonic-Clonic Seizure)
|
12.5 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Double-blind: Placebo
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Double-blind: Staccato Alprazolam 1.0 mg
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Double-blind: Staccato Alprazolam 2.0 mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg)
n=8 participants at risk
Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Placebo
n=40 participants at risk
Participants received a single dose of placebo matching to alprazolam as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Staccato Alprazolam 1.0 mg
n=38 participants at risk
Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Staccato Alprazolam 2.0 mg
n=38 participants at risk
Participants received a single dose of alprazolam 2.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
|---|---|---|---|---|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Nervous system disorders
Seizure cluster
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.5%
1/40 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.5%
1/40 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.5%
1/40 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
Other adverse events
| Measure |
Open-label: Staccato Alprazolam (STAP-001) 1.0 Milligram (mg)
n=8 participants at risk
Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Placebo
n=40 participants at risk
Participants received a single dose of placebo matching to alprazolam as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Staccato Alprazolam 1.0 mg
n=38 participants at risk
Participants received a single dose of alprazolam 1.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
Double-blind: Staccato Alprazolam 2.0 mg
n=38 participants at risk
Participants received a single dose of alprazolam 2.0 mg as an oral inhalation using the Staccato delivery system at the onset of their predictable seizure episode from Day 1 through the end of Day 7.
|
|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.5%
1/40 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
18.4%
7/38 • Number of events 8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
10.5%
4/38 • Number of events 4 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.5%
1/40 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
15.8%
6/38 • Number of events 6 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
10.5%
4/38 • Number of events 4 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
5.0%
2/40 • Number of events 2 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
5.3%
2/38 • Number of events 2 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
5.3%
2/38 • Number of events 3 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Nervous system disorders
Sedation
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
5.3%
2/38 • Number of events 2 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
5.0%
2/40 • Number of events 2 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Nervous system disorders
Tremor
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.5%
1/40 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
10.5%
4/38 • Number of events 4 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
18.4%
7/38 • Number of events 7 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
12.5%
1/8 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
5.3%
2/38 • Number of events 2 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.5%
1/40 • Number of events 2 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
5.3%
2/38 • Number of events 2 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.5%
1/40 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.5%
1/40 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Eye disorders
Diplopia
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Eye disorders
Dry eye
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Metabolism and nutrition disorders
Myalgia
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
12.5%
1/8 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
General disorders
Feeling abnormal
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
General disorders
Injury associated with device
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
General disorders
Fatigue
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
5.0%
2/40 • Number of events 2 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Infections and infestations
Gastroenteritis viral
|
12.5%
1/8 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Investigations
Urine phosphorus
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.5%
1/40 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.6%
1/38 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
12.5%
1/8 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/40 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.5%
1/40 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.5%
1/40 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/8 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
2.5%
1/40 • Number of events 1 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
0.00%
0/38 • From Screening up to 12 weeks
The Safety Population included all participants who received study drug during the Treatment Period from either Open-label Feasibility or Double-blind Phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60