Trial Outcomes & Findings for A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease (NCT NCT03007888)
NCT ID: NCT03007888
Last Updated: 2022-06-06
Results Overview
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Day 1
Results posted on
2022-06-06
Participant Flow
A total of 39 subjects were screened at 10 study sites between November 8, 2016 and August 1, 2017
28 of 39 subjects were enrolled and randomized
Participant milestones
| Measure |
IPX203 First Then Sinemet
Participants first received IPX203 ER CD-LD Capsules for 15 days After a Washout Period of 7 days; participants then received Sinemet (IR CD-LD) Tablets for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.
|
Sinemet First Then IPX203
Participants first received Sinemet for 15 days After a Washout Period of 7 days; participants then received IPX203 for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.
|
|---|---|---|
|
Second Interventions (14 Days)
NOT COMPLETED
|
0
|
0
|
|
First Intervention (14 Days)
STARTED
|
15
|
13
|
|
First Intervention (14 Days)
COMPLETED
|
14
|
13
|
|
First Intervention (14 Days)
NOT COMPLETED
|
1
|
0
|
|
Washout (7 Days)
STARTED
|
14
|
13
|
|
Washout (7 Days)
COMPLETED
|
14
|
13
|
|
Washout (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Interventions (14 Days)
STARTED
|
14
|
13
|
|
Second Interventions (14 Days)
COMPLETED
|
14
|
13
|
Reasons for withdrawal
| Measure |
IPX203 First Then Sinemet
Participants first received IPX203 ER CD-LD Capsules for 15 days After a Washout Period of 7 days; participants then received Sinemet (IR CD-LD) Tablets for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.
|
Sinemet First Then IPX203
Participants first received Sinemet for 15 days After a Washout Period of 7 days; participants then received IPX203 for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.
|
|---|---|---|
|
First Intervention (14 Days)
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease
Baseline characteristics by cohort
| Measure |
All Study Participants
n=28 Participants
The recommended first morning dose of IPX203 on Day 1 was based on the subject's prestudy IR CD-LD morning dose
The initial IR CD-LD dosing regimen was the same as the subject's stable prestudy regimen (unless s/he was taking a single daily bedtime dose of CR CD-LD, either alone or in combination with IR CD-LD, in which case, the CR CD-LD dose was discontinued and substituted with a 1:1 milligram-equivalent IR CD-LD dose).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
|
Age, Continuous
|
66.43 Years
STANDARD_DEVIATION 10.057 • n=5 Participants
|
|
Sex: Female, Male
Gender · Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Gender · Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=5 Participants
|
|
Age at Parkinson's disease onset
|
58.9 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Duration of Parkinson's disease
|
7.5 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
Hoehn and Yahr Score
I
|
0 Participants
n=5 Participants
|
|
Hoehn and Yahr Score
II
|
24 Participants
n=5 Participants
|
|
Hoehn and Yahr Score
III
|
4 Participants
n=5 Participants
|
|
Hoehn and Yahr Score
IV
|
0 Participants
n=5 Participants
|
|
Montreal Cognitive Assessment Score (On State)
MoCA score<24
|
0 Participants
n=5 Participants
|
|
Montreal Cognitive Assessment Score (On State)
MoCA score 24 to <26
|
3 Participants
n=5 Participants
|
|
Montreal Cognitive Assessment Score (On State)
MoCA score 26 to <28
|
13 Participants
n=5 Participants
|
|
Montreal Cognitive Assessment Score (On State)
MoCA score 28 to <30
|
7 Participants
n=5 Participants
|
|
Montreal Cognitive Assessment Score (On State)
30
|
5 Participants
n=5 Participants
|
|
Movement Disorder Society version of the Unified Parkinson's Disease Rating Scale Part III while On
|
19.1 units on a scale
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Movement Disorder Society version of the Unified Parkinson's Disease Rating Scale Part III while Off
|
42.5 units on a scale
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Total "off" time from subject diary
|
5.2 hours
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Total Good "on" time from subject diary
|
9.9 hours
STANDARD_DEVIATION 2.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Randomized subjects who completed both periods
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Outcome measures
| Measure |
IPX203
n=27 Participants
Participants who received IPX203 ER Capsules on Day 1 of the study
|
Sinemet
n=27 Participants
Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
|
|---|---|---|
|
Levodopa Cmax Following First Dose on Day 1
|
2857.56 ng/mL
Standard Deviation 1204.506
|
2173.30 ng/mL
Standard Deviation 1240.774
|
PRIMARY outcome
Timeframe: Day 1Population: Randomized subjects who completed both periods
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Outcome measures
| Measure |
IPX203
n=27 Participants
Participants who received IPX203 ER Capsules on Day 1 of the study
|
Sinemet
n=27 Participants
Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
|
|---|---|---|
|
Levodopa Tmax Following First Dose on Day 1
|
2.07 hour
Standard Deviation 0.997
|
0.94 hour
Standard Deviation 0.560
|
PRIMARY outcome
Timeframe: Day 1Population: Randomized subjects who completed both periods
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Outcome measures
| Measure |
IPX203
n=27 Participants
Participants who received IPX203 ER Capsules on Day 1 of the study
|
Sinemet
n=27 Participants
Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
|
|---|---|---|
|
Levodopa t1/2 Following First Dose on Day 1
|
1.658 hour
Standard Deviation 0.4838
|
1.420 hour
Standard Deviation 0.3194
|
PRIMARY outcome
Timeframe: Day 1Population: Randomized subjects who completed both periods
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Outcome measures
| Measure |
IPX203
n=27 Participants
Participants who received IPX203 ER Capsules on Day 1 of the study
|
Sinemet
n=27 Participants
Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
|
|---|---|---|
|
Levodopa AUCt Following First Dose on Day 1
|
12107.60 ng.h/mL
Standard Deviation 5793.881
|
3747.61 ng.h/mL
Standard Deviation 1819.141
|
PRIMARY outcome
Timeframe: Day 1Population: Randomized subjects who completed both periods
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Outcome measures
| Measure |
IPX203
n=27 Participants
Participants who received IPX203 ER Capsules on Day 1 of the study
|
Sinemet
n=27 Participants
Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
|
|---|---|---|
|
Levodopa AUCinf Following First Dose on Day 1
|
13968.57 ng.h/mL
Standard Deviation 7606.901
|
4308.37 ng.h/mL
Standard Deviation 2123.057
|
PRIMARY outcome
Timeframe: Day 1Population: Randomized subjects who completed both periods
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Outcome measures
| Measure |
IPX203
n=27 Participants
Participants who received IPX203 ER Capsules on Day 1 of the study
|
Sinemet
n=27 Participants
Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
|
|---|---|---|
|
Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1
|
88.965 Percentage
Standard Deviation 21.7583
|
0 Percentage
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Day 1Population: Randomized subjects who completed both periods
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Outcome measures
| Measure |
IPX203
n=27 Participants
Participants who received IPX203 ER Capsules on Day 1 of the study
|
Sinemet
n=27 Participants
Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
|
|---|---|---|
|
Carbidopa Cmax Following First Dose on Day 1
|
500.35 ng/mL
Standard Deviation 316.299
|
151.50 ng/mL
Standard Deviation 103.225
|
PRIMARY outcome
Timeframe: Day 1Population: Randomized subjects who completed both periods
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Outcome measures
| Measure |
IPX203
n=27 Participants
Participants who received IPX203 ER Capsules on Day 1 of the study
|
Sinemet
n=27 Participants
Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
|
|---|---|---|
|
Carbidopa Tmax Following First Dose on Day 1
|
2.61 hour
Standard Deviation 0.655
|
2.07 hour
Standard Deviation 0.675
|
PRIMARY outcome
Timeframe: Day 1Population: Randomized subjects who completed both periods
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Outcome measures
| Measure |
IPX203
n=27 Participants
Participants who received IPX203 ER Capsules on Day 1 of the study
|
Sinemet
n=27 Participants
Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
|
|---|---|---|
|
Carbidopa t1/2 Following First Dose on Day 1
|
2.015 hour
Standard Deviation 0.5159
|
1.969 hour
Standard Deviation 0.7187
|
PRIMARY outcome
Timeframe: Day 1Population: Randomized subjects who completed both periods
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Outcome measures
| Measure |
IPX203
n=27 Participants
Participants who received IPX203 ER Capsules on Day 1 of the study
|
Sinemet
n=27 Participants
Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
|
|---|---|---|
|
Carbidopa AUCt Following First Dose on Day 1
|
1940.51 ng.h/mL
Standard Deviation 1095.449
|
436.63 ng.h/mL
Standard Deviation 286.286
|
PRIMARY outcome
Timeframe: Day 1Population: Randomized subjects who completed both periods
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Outcome measures
| Measure |
IPX203
n=27 Participants
Participants who received IPX203 ER Capsules on Day 1 of the study
|
Sinemet
n=27 Participants
Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
|
|---|---|---|
|
Carbidopa AUCinf Following First Dose on Day 1
|
2239.61 ng.h/mL
Standard Deviation 1232.234
|
610.44 ng.h/mL
Standard Deviation 407.305
|
PRIMARY outcome
Timeframe: Day 1Population: Randomized subjects who completed both periods
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Outcome measures
| Measure |
IPX203
n=27 Participants
Participants who received IPX203 ER Capsules on Day 1 of the study
|
Sinemet
n=27 Participants
Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
|
|---|---|---|
|
Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1
|
117.442 Percentage
Standard Deviation 43.4176
|
0 Percentage
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Day 15Population: Randomized subjects who completed both periods
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Outcome measures
| Measure |
IPX203
n=27 Participants
Participants who received IPX203 ER Capsules on Day 1 of the study
|
Sinemet
n=27 Participants
Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
|
|---|---|---|
|
Levodopa Cmax Following First Dose on Day 15
|
2767.96 ng/mL
Standard Deviation 1258.525
|
2356.85 ng/mL
Standard Deviation 1178.628
|
PRIMARY outcome
Timeframe: Day 15Population: Randomized subjects who completed both periods
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Outcome measures
| Measure |
IPX203
n=27 Participants
Participants who received IPX203 ER Capsules on Day 1 of the study
|
Sinemet
n=27 Participants
Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
|
|---|---|---|
|
Levodopa Tmax Following First Dose on Day 15
|
1.91 hour
Standard Deviation 1.241
|
0.83 hour
Standard Deviation 0.439
|
PRIMARY outcome
Timeframe: Day 15Population: Randomized subjects who completed both periods
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Outcome measures
| Measure |
IPX203
n=27 Participants
Participants who received IPX203 ER Capsules on Day 1 of the study
|
Sinemet
n=27 Participants
Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
|
|---|---|---|
|
Levodopa AUCtau Following First Dose on Day 15
|
11213.76 ng.h/ML
Standard Deviation 4887.246
|
3879.39 ng.h/ML
Standard Deviation 1744.328
|
PRIMARY outcome
Timeframe: Day 15Population: Randomized subjects who completed both periods
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Outcome measures
| Measure |
IPX203
n=27 Participants
Participants who received IPX203 ER Capsules on Day 1 of the study
|
Sinemet
n=27 Participants
Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
|
|---|---|---|
|
Carbidopa Cmax Following First Dose on Day 15
|
478.66 ng/mL
Standard Deviation 290.584
|
145.67 ng/mL
Standard Deviation 82.541
|
PRIMARY outcome
Timeframe: Day 15Population: Randomized subjects who completed both periods
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Outcome measures
| Measure |
IPX203
n=27 Participants
Participants who received IPX203 ER Capsules on Day 1 of the study
|
Sinemet
n=27 Participants
Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
|
|---|---|---|
|
Carbidopa Tmax Following First Dose on Day 15
|
2.52 hour
Standard Deviation 0.74
|
2.20 hour
Standard Deviation 0.639
|
PRIMARY outcome
Timeframe: Day 15Population: Randomized subjects who completed both periods
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Outcome measures
| Measure |
IPX203
n=27 Participants
Participants who received IPX203 ER Capsules on Day 1 of the study
|
Sinemet
n=27 Participants
Participants who received Sinemet (IR CD-LD) Capsules on Day 1 of the study
|
|---|---|---|
|
Carbidopa AUCtau Following First Dose on Day 15
|
1892.39 ng.h/mL
Standard Deviation 1017.537
|
415.83 ng.h/mL
Standard Deviation 279.487
|
Adverse Events
IPX203
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Sinemet
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Washout Period
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IPX203
n=28 participants at risk
Participants received IPX203 ER CD-LD Capsules
|
Sinemet
n=27 participants at risk
Participant received Sinemet (IR CD-LD) Tablets
|
Washout Period
n=28 participants at risk
Washout between Period 1 and Period 2
|
|---|---|---|---|
|
Vascular disorders
Hypertension
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Gastrointestinal disorders
Diarrhorea
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
Other adverse events
| Measure |
IPX203
n=28 participants at risk
Participants received IPX203 ER CD-LD Capsules
|
Sinemet
n=27 participants at risk
Participant received Sinemet (IR CD-LD) Tablets
|
Washout Period
n=28 participants at risk
Washout between Period 1 and Period 2
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
3.7%
1/27 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
3.7%
1/27 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Gastrointestinal disorders
Dry Mouth
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Gastrointestinal disorders
Nausea
|
7.1%
2/28 • Number of events 2 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Infections and infestations
Bronchitis
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Infections and infestations
Upper respiratiory track infection
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
3.7%
1/27 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Infections and infestations
Urinary Tract infection
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Nervous system disorders
Dizziness
|
7.1%
2/28 • Number of events 2 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Nervous system disorders
Dyskinesia
|
17.9%
5/28 • Number of events 5 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Nervous system disorders
Dystonia
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Nervous system disorders
Occipital Neuralgia
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Nervous system disorders
Somnolence
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Nervous system disorders
Tremor
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Psychiatric disorders
Confusional State
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Psychiatric disorders
Insomnia
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Vascular disorders
Hypotension
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Vascular disorders
Orthostatic Hypertension
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
|
Vascular disorders
Orthostatic Hypotension
|
3.6%
1/28 • Number of events 1 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/27 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
0.00%
0/28 • 15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
|
Additional Information
Pamela Fitzpatrick, Director, Specialty Regulatory Affairs
Impax Laboratories, LLC
Phone: 631-633-2104
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place