Trial Outcomes & Findings for Therapeutic Potential for Intranasal Levodopa in Parkinson's Disease -Off Reversal (NCT NCT03541356)
NCT ID: NCT03541356
Last Updated: 2020-08-12
Results Overview
Assessment of treatment emergent adverse events after single dosing with INP103 (L-dopa or L-dopa/carbidopa)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
7 days
Results posted on
2020-08-12
Participant Flow
Parkinson's disease patients at movement disorder clinics in Australia
Confirmation of L-dopa responsiveness at Visit 2, prior to randomization
Participant milestones
| Measure |
Placebo
Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
|
L-dopa 35 mg
L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
|
L-dopa 70 mg
L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
L-dopa 140 mg
L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
|
L-dopa 70 mg/Carbidopa 7 mg
L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Therapeutic Potential for Intranasal Levodopa in Parkinson's Disease -Off Reversal
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
|
L-dopa 35 mg
n=6 Participants
L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
|
L-dopa 70 mg
n=6 Participants
L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
L-dopa 140 mg
n=6 Participants
L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
|
L-dopa 70 mg/Carbidopa 7 mg
n=6 Participants
L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
Australia
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
32 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 7 daysAssessment of treatment emergent adverse events after single dosing with INP103 (L-dopa or L-dopa/carbidopa)
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
|
L-dopa 35 mg
n=6 Participants
L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
|
L-dopa 70 mg
n=6 Participants
L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
L-dopa 140 mg
n=6 Participants
L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
|
L-dopa 70 mg/Carbidopa 7 mg
n=6 Participants
L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
5 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: For L-dopa 35 mg, 70 mg, 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minPopulation: Subjects who received L-dopa or L-dopa/carbidopa. Placebo subjects therefore not included.
Area under the Plasma Concentration-time Curve for L-dopa from Time = 0 to Time = 2 hours post dose. For the L-dopa 35 mg, L-dopa 70 mg, L-dopa 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For the L-dopa 70 mg/carbidopa 7 mg treatment arm, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
|
L-dopa 35 mg
n=6 Participants
L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
|
L-dopa 70 mg
n=6 Participants
L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
L-dopa 140 mg
n=6 Participants
L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
|
L-dopa 70 mg/Carbidopa 7 mg
L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
|---|---|---|---|---|---|
|
AUC0-2hr for L-dopa
|
240.71 hours*ng/mL
Standard Deviation 117.819
|
463.49 hours*ng/mL
Standard Deviation 260.093
|
725.29 hours*ng/mL
Standard Deviation 456.566
|
552.75 hours*ng/mL
Standard Deviation 177.979
|
—
|
SECONDARY outcome
Timeframe: For L-dopa 35 mg, 70 mg, 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.Population: Subjects who received L-dopa. Placebo subjects not included.
Maximum Observed Plasma Concentration of L-dopa from Time = 0 to Time = 2 hours post dose. For the L-dopa 35 mg, L-dopa 70 mg, L-dopa 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For the L-dopa 70 mg/carbidopa 7 mg treatment arm, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
|
L-dopa 35 mg
n=6 Participants
L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
|
L-dopa 70 mg
n=6 Participants
L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
L-dopa 140 mg
n=6 Participants
L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
|
L-dopa 70 mg/Carbidopa 7 mg
L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
|---|---|---|---|---|---|
|
Cmax of L-dopa
|
185.80 ng/mL
Standard Deviation 78.144
|
362.68 ng/mL
Standard Deviation 195.265
|
643.65 ng/mL
Standard Deviation 462.469
|
445.75 ng/mL
Standard Deviation 183.746
|
—
|
SECONDARY outcome
Timeframe: For L-dopa 35 mg, 70 mg, 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.Population: Subjects who received L-dopa. Placebo subjects not included.
Time to Reach the Maximum Plasma Concentration (Cmax) of L-dopa
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
|
L-dopa 35 mg
n=6 Participants
L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
|
L-dopa 70 mg
n=6 Participants
L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
L-dopa 140 mg
n=6 Participants
L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
|
L-dopa 70 mg/Carbidopa 7 mg
L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
|---|---|---|---|---|---|
|
Tmax of L-dopa
|
60.17 minutes
Standard Deviation 37.950
|
66.00 minutes
Standard Deviation 38.735
|
70.00 minutes
Standard Deviation 15.505
|
92.00 minutes
Standard Deviation 27.481
|
—
|
SECONDARY outcome
Timeframe: For L-dopa 35 mg, 70 mg, 140 mg, assessment occurred at pre-dose, 15, 30, 45, 60, 90 and 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, assessment occurred at pre-dose, 30, 60, 90 and 120 minutes post-dose.Population: All participants were analyzed.
MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Maximum score is 132, minimum is zero. High score means worse outcome. For the L-dopa 35 mg, L-dopa 70 mg, L-dopa 140 mg treatment groups, assessment occurred at pre-dose, 15, 30, 45, 60, 90 and 120 minutes post-dose. For the L-dopa 70 mg/carbidopa 7 mg treatment arm, assessment occurred at pre-dose, 30, 60, 90 and 120 minutes post-dose.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
|
L-dopa 35 mg
n=6 Participants
L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
|
L-dopa 70 mg
n=6 Participants
L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
L-dopa 140 mg
n=6 Participants
L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
|
L-dopa 70 mg/Carbidopa 7 mg
n=6 Participants
L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in MDS-UPDRS Score Over 2 Hours for C1, C2, C3 and Change From Baseline at 30, 60, 90, 120 Minutes for C4, in MDS-UPDRS Part III Score
15 minutes
|
-3.5 score on a scale
Standard Deviation 3.89
|
-4.5 score on a scale
Standard Deviation 4.46
|
0.8 score on a scale
Standard Deviation 9.20
|
-9.0 score on a scale
Standard Deviation 6.16
|
NA score on a scale
Standard Deviation NA
Participants in this arm were not tested at this time point.
|
|
Mean Change From Baseline in MDS-UPDRS Score Over 2 Hours for C1, C2, C3 and Change From Baseline at 30, 60, 90, 120 Minutes for C4, in MDS-UPDRS Part III Score
30 minutes
|
-8.5 score on a scale
Standard Deviation 6.52
|
-6.7 score on a scale
Standard Deviation 4.89
|
-8.5 score on a scale
Standard Deviation 9.09
|
-12.7 score on a scale
Standard Deviation 7.79
|
-3.7 score on a scale
Standard Deviation 3.83
|
|
Mean Change From Baseline in MDS-UPDRS Score Over 2 Hours for C1, C2, C3 and Change From Baseline at 30, 60, 90, 120 Minutes for C4, in MDS-UPDRS Part III Score
45 minutes
|
-13.5 score on a scale
Standard Deviation 7.09
|
-4.7 score on a scale
Standard Deviation 4.03
|
-12.8 score on a scale
Standard Deviation 11.05
|
-13.7 score on a scale
Standard Deviation 8.91
|
NA score on a scale
Standard Deviation NA
Participants in this arm were not tested at this time point.
|
|
Mean Change From Baseline in MDS-UPDRS Score Over 2 Hours for C1, C2, C3 and Change From Baseline at 30, 60, 90, 120 Minutes for C4, in MDS-UPDRS Part III Score
60 minutes
|
-12.5 score on a scale
Standard Deviation 7.87
|
-6.8 score on a scale
Standard Deviation 4.54
|
-15.7 score on a scale
Standard Deviation 9.58
|
-13.5 score on a scale
Standard Deviation 8.29
|
-0.8 score on a scale
Standard Deviation 10.63
|
|
Mean Change From Baseline in MDS-UPDRS Score Over 2 Hours for C1, C2, C3 and Change From Baseline at 30, 60, 90, 120 Minutes for C4, in MDS-UPDRS Part III Score
90 minutes
|
-10.8 score on a scale
Standard Deviation 9.35
|
-10.3 score on a scale
Standard Deviation 13.56
|
-15.5 score on a scale
Standard Deviation 10.03
|
-9.0 score on a scale
Standard Deviation 5.76
|
-3.7 score on a scale
Standard Deviation 10.76
|
|
Mean Change From Baseline in MDS-UPDRS Score Over 2 Hours for C1, C2, C3 and Change From Baseline at 30, 60, 90, 120 Minutes for C4, in MDS-UPDRS Part III Score
120 minutes
|
-8.8 score on a scale
Standard Deviation 10.61
|
-11.0 score on a scale
Standard Deviation 9.47
|
-13.8 score on a scale
Standard Deviation 11.97
|
-7.2 score on a scale
Standard Deviation 9.09
|
-3.2 score on a scale
Standard Deviation 9.22
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: All participants were analyzed.
MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
|
L-dopa 35 mg
n=6 Participants
L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
|
L-dopa 70 mg
n=6 Participants
L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
L-dopa 140 mg
n=6 Participants
L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
|
L-dopa 70 mg/Carbidopa 7 mg
n=6 Participants
L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
|---|---|---|---|---|---|
|
Time to Response (Defined as Improvement of 30% in MDS-UPDRS Part III Score From Baseline)
|
45.0 minutes
Interval 35.0 to
The upper bound of the 95% CI could not be calculated due to the number of participants not achieving a response in the analysis time frame
|
NA minutes
Interval 40.0 to
The median and the upper bound of the 95% CI could not be calculated due to the number of participants not achieving a response in the analysis time frame
|
54.0 minutes
Interval 15.0 to
The upper bound of the 95% CI could not be calculated due to the number of participants not achieving a response in the analysis time frame
|
30.0 minutes
Interval 15.0 to
The upper bound of the 95% CI could not be calculated due to the number of participants not achieving a response in the analysis time frame
|
NA minutes
Interval 32.0 to
The median and the upper bound of the 95% CI could not be calculated due to the number of participants not achieving a response in the analysis time frame
|
SECONDARY outcome
Timeframe: From time = 0 to 2 hours post-dosePopulation: All participants were analyzed.
MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
|
L-dopa 35 mg
n=6 Participants
L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
|
L-dopa 70 mg
n=6 Participants
L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
L-dopa 140 mg
n=6 Participants
L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
|
L-dopa 70 mg/Carbidopa 7 mg
n=6 Participants
L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
|---|---|---|---|---|---|
|
Cumulative Number of Responders (Defined as Improvement of 30% in MDS-UPDRS Part III Score From Baseline)
60 minutes
|
6 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
|
Cumulative Number of Responders (Defined as Improvement of 30% in MDS-UPDRS Part III Score From Baseline)
15 minutes
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
NA Participants
Subjects in this arm were not analyzed at this time point.
|
|
Cumulative Number of Responders (Defined as Improvement of 30% in MDS-UPDRS Part III Score From Baseline)
30 minutes
|
3 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
|
Cumulative Number of Responders (Defined as Improvement of 30% in MDS-UPDRS Part III Score From Baseline)
45 minutes
|
4 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
NA Participants
Subjects in this arm were not analyzed at this time point.
|
|
Cumulative Number of Responders (Defined as Improvement of 30% in MDS-UPDRS Part III Score From Baseline)
90 minutes
|
6 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
|
Cumulative Number of Responders (Defined as Improvement of 30% in MDS-UPDRS Part III Score From Baseline)
120 minutes
|
6 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: For L-dopa 35 mg, 70 mg, 140 mg, assessments were made at pre-dose, 15, 30, 45, 60, 90, 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, assessments were made at pre-dose, 50, 60, 90, 120 minutes post-dose.Population: All participants were included in the analysis
MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
|
L-dopa 35 mg
n=6 Participants
L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
|
L-dopa 70 mg
n=6 Participants
L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
L-dopa 140 mg
n=6 Participants
L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
|
L-dopa 70 mg/Carbidopa 7 mg
n=6 Participants
L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
|---|---|---|---|---|---|
|
Area Under the Curve (AUC) of Change From Baseline in MDS-UPDRS Part III Scores
15 minutes
|
-26.25 change in score*minutes
Standard Deviation 29.144
|
-33.50 change in score*minutes
Standard Deviation 33.697
|
7.00 change in score*minutes
Standard Deviation 69.206
|
-67.50 change in score*minutes
Standard Deviation 46.233
|
NA change in score*minutes
Standard Deviation NA
Participants in this arm were not assessed at this time point.
|
|
Area Under the Curve (AUC) of Change From Baseline in MDS-UPDRS Part III Scores
30 minutes
|
-237.63 change in score*minutes
Standard Deviation 276.197
|
-138.58 change in score*minutes
Standard Deviation 138.105
|
-50.50 change in score*minutes
Standard Deviation 203.053
|
-232.83 change in score*minutes
Standard Deviation 153.638
|
-230.08 change in score*minutes
Standard Deviation 250.832
|
|
Area Under the Curve (AUC) of Change From Baseline in MDS-UPDRS Part III Scores
45 minutes
|
-264.92 change in score*minutes
Standard Deviation 178.969
|
-201.92 change in score*minutes
Standard Deviation 162.256
|
-210.50 change in score*minutes
Standard Deviation 334.216
|
-426.83 change in score*minutes
Standard Deviation 274.566
|
NA change in score*minutes
Standard Deviation NA
Participants in this arm were not assessed at this time point.
|
|
Area Under the Curve (AUC) of Change From Baseline in MDS-UPDRS Part III Scores
60 minutes
|
-573.88 change in score*minutes
Standard Deviation 371.782
|
-296.50 change in score*minutes
Standard Deviation 241.271
|
-424.25 change in score*minutes
Standard Deviation 464.545
|
-630.58 change in score*minutes
Standard Deviation 401.947
|
-295.25 change in score*minutes
Standard Deviation 412.042
|
|
Area Under the Curve (AUC) of Change From Baseline in MDS-UPDRS Part III Scores
90 minutes
|
-919.75 change in score*minutes
Standard Deviation 530.872
|
-575.17 change in score*minutes
Standard Deviation 486.241
|
-896.67 change in score*minutes
Standard Deviation 671.116
|
-968.08 change in score*minutes
Standard Deviation 587.629
|
-362.75 change in score*minutes
Standard Deviation 676.456
|
|
Area Under the Curve (AUC) of Change From Baseline in MDS-UPDRS Part III Scores
120 minutes
|
-1215.75 change in score*minutes
Standard Deviation 765.287
|
-903.67 change in score*minutes
Standard Deviation 804.196
|
-1324.83 change in score*minutes
Standard Deviation 863.122
|
-1210.58 change in score*minutes
Standard Deviation 714.512
|
-465.25 change in score*minutes
Standard Deviation 932.842
|
SECONDARY outcome
Timeframe: From time = 0 to 2 hours post-dosePopulation: All subjects were included in this analysis
MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total of the subscales has a maximum value of 132 and a minimum value of zero. Lower scores indicate better motor function. A negative change from baseline indicates improved motor function.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
|
L-dopa 35 mg
n=6 Participants
L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
|
L-dopa 70 mg
n=6 Participants
L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
L-dopa 140 mg
n=6 Participants
L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
|
L-dopa 70 mg/Carbidopa 7 mg
n=6 Participants
L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
|---|---|---|---|---|---|
|
Mean Maximum Change From Baseline in MDS-UPDRS Part III Score
|
-15.5 score on a scale
Standard Deviation 6.35
|
-14.0 score on a scale
Standard Deviation 11.15
|
-20.3 score on a scale
Standard Deviation 11.18
|
-15.3 score on a scale
Standard Deviation 8.12
|
-7.5 score on a scale
Standard Deviation 6.72
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: All participants were included in the analysis
Investigators will evaluate subjects' fluctuations in motor functions at 15, 30, 45, 60, 90, 120, and 240 minutes post-dose to determine if they are "ON".
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
|
L-dopa 35 mg
n=6 Participants
L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
|
L-dopa 70 mg
n=6 Participants
L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
L-dopa 140 mg
n=6 Participants
L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
|
L-dopa 70 mg/Carbidopa 7 mg
n=6 Participants
L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
|---|---|---|---|---|---|
|
Subjective Time to "ON" as Evaluated by the Investigator
|
45.0 minutes
Interval 30.0 to 240.0
|
240.0 minutes
Interval 90.0 to
One or more subjects in this arm did not achieve ON by the end of the assessment period. Therefore upper range was \>240 minutes.
|
30.0 minutes
Interval 15.0 to 240.0
|
30.0 minutes
Interval 15.0 to 240.0
|
240.0 minutes
Interval 30.0 to 240.0
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: All participants were included in the analysis.
Subjects were asked to provide self-assessments at 15, 30, 45, 60, 90, 120, and 240 minutes post-dose as to whether they considered themselves to be "ON".
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
|
L-dopa 35 mg
n=6 Participants
L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
|
L-dopa 70 mg
n=6 Participants
L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
L-dopa 140 mg
n=6 Participants
L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
|
L-dopa 70 mg/Carbidopa 7 mg
n=6 Participants
L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
|---|---|---|---|---|---|
|
Assessment of Time to "ON" as Evaluated by Subject Self-assessment
|
40.0 minutes
Interval 15.0 to 240.0
|
240.0 minutes
Interval 95.0 to
One or more participants in this arm did not perceive themselves to be "ON" by the end of the assessment period, therefore the full range is 95 to \>240 minutes
|
39.0 minutes
Interval 15.0 to 240.0
|
30.0 minutes
Interval 15.0 to 240.0
|
232.5 minutes
Interval 31.0 to 240.0
|
SECONDARY outcome
Timeframe: Plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose and AUC calculated from these from time 0 to 120 minutes.Population: Subjects who received the combination of L-dopa/carbidopa
Area under the concentration time curve for carbidopa
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
|
L-dopa 35 mg
L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
|
L-dopa 70 mg
L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
L-dopa 140 mg
L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
|
L-dopa 70 mg/Carbidopa 7 mg
L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
|---|---|---|---|---|---|
|
AUC0-2h for Carbidopa
|
114.80 hours*ng/mL
Standard Deviation 30.384
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.Population: Subjects who received L-dopa/carbidopa
Maximum concentration of carbidopa
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
|
L-dopa 35 mg
L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
|
L-dopa 70 mg
L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
L-dopa 140 mg
L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
|
L-dopa 70 mg/Carbidopa 7 mg
L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
|---|---|---|---|---|---|
|
Cmax of Carbidopa
|
80.23 ng/mL
Standard Deviation 22.945
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.Population: Subjects who received L-dopa/carbidopa
Time to reach the maximum concentration of carbidopa
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
|
L-dopa 35 mg
L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
|
L-dopa 70 mg
L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
L-dopa 140 mg
L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
|
L-dopa 70 mg/Carbidopa 7 mg
L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
|---|---|---|---|---|---|
|
Tmax of Carbidopa
|
44.50 minutes
Standard Deviation 13.882
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: All participants were analyzed.
MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Maximum score is 132, minimum is zero. High score means worse outcome.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
|
L-dopa 35 mg
n=6 Participants
L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
|
L-dopa 70 mg
n=6 Participants
L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
L-dopa 140 mg
n=6 Participants
L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
|
L-dopa 70 mg/Carbidopa 7 mg
n=6 Participants
L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
|---|---|---|---|---|---|
|
Duration of Response, Where Response is Defined as an Improvement of 30% in MDS-UPDRS Part III Score From Baseline.
|
66.9 minutes
Standard Deviation 48.35
|
23.3 minutes
Standard Deviation 36.70
|
57.3 minutes
Standard Deviation 42.72
|
37.5 minutes
Standard Deviation 42.25
|
15.0 minutes
Standard Deviation 25.10
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
L-dopa 35 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
L-dopa 70 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
L-dopa 140 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
L-dopa 70 mg/Carbidopa 7 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=8 participants at risk
Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device
|
L-dopa 35 mg
n=6 participants at risk
L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
|
L-dopa 70 mg
n=6 participants at risk
L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
L-dopa 140 mg
n=6 participants at risk
L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
|
L-dopa 70 mg/Carbidopa 7 mg
n=6 participants at risk
L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory tract infection
|
0.00%
0/8 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhoea
|
0.00%
0/8 • 7 days
|
0.00%
0/6 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
sinus pain
|
0.00%
0/8 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/8 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
dry throat
|
12.5%
1/8 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.00%
0/8 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
0.00%
0/8 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
nasal discomfort
|
12.5%
1/8 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
nasal dryness
|
0.00%
0/8 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
nasal oedema
|
0.00%
0/8 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
paranasal sinus discomfort
|
0.00%
0/8 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
paranasal sinus hyposecretion
|
0.00%
0/8 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
sneezing
|
12.5%
1/8 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
|
Nervous system disorders
headache
|
0.00%
0/8 • 7 days
|
33.3%
2/6 • Number of events 2 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
|
Nervous system disorders
somnolence
|
0.00%
0/8 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
|
Nervous system disorders
dizziness
|
0.00%
0/8 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
|
General disorders
fatigue
|
12.5%
1/8 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
|
General disorders
feeling abnormal
|
0.00%
0/8 • 7 days
|
0.00%
0/6 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
|
General disorders
hyperthermia
|
0.00%
0/8 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
|
Vascular disorders
hypertension
|
12.5%
1/8 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
|
Vascular disorders
orthostatic hypotension
|
0.00%
0/8 • 7 days
|
0.00%
0/6 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
|
Infections and infestations
rhinitis
|
0.00%
0/8 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/8 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
|
Musculoskeletal and connective tissue disorders
joint noise
|
0.00%
0/8 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
12.5%
1/8 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
|
Cardiac disorders
tachycardia
|
12.5%
1/8 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
|
Eye disorders
lacrimation increased
|
0.00%
0/8 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
|
Injury, poisoning and procedural complications
procedural pain
|
0.00%
0/8 • 7 days
|
0.00%
0/6 • 7 days
|
0.00%
0/6 • 7 days
|
16.7%
1/6 • Number of events 1 • 7 days
|
0.00%
0/6 • 7 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place