Trial Outcomes & Findings for Parcopa Versus Carbidopa-levodopa in a Single Dose Cross-over Comparison Study (NCT NCT00590122)
NCT ID: NCT00590122
Last Updated: 2023-03-14
Results Overview
Time to "on" state (benefit with regard to mobility, stiffness and slowness) with parcopa versus carbidopa/levodopa immediate release compound. This measurement is compared between Parcopa and carbidopa/levodopa wit the first morning dose of each intervention. Study duration was 2 days.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
first dose of day for each arm
Results posted on
2023-03-14
Participant Flow
Crossover study design
Participant milestones
| Measure |
B-Parcopa Arm First Then Crossover to Carbidopa/Levodopa Arm
Parcopa: at subjects current stable dose of comparator first (Day 1) then crossover to the carbidopa/levodopa arm (Day 2)
|
A-Carbidopa/Levodopa Arm Then Crossover to Parcopa Arm
carbidopa-levodopa at subjects current stable dose (Day 1) then crossover to the parcopa comparator arm of the study (Day 2)
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
B-Parcopa Arm First Then Crossover to Carbidopa/Levodopa Arm
Parcopa: at subjects current stable dose of comparator first (Day 1) then crossover to the carbidopa/levodopa arm (Day 2)
|
A-Carbidopa/Levodopa Arm Then Crossover to Parcopa Arm
carbidopa-levodopa at subjects current stable dose (Day 1) then crossover to the parcopa comparator arm of the study (Day 2)
|
|---|---|---|
|
Overall Study
swallowed oral dissolving dose
|
1
|
0
|
Baseline Characteristics
Parcopa Versus Carbidopa-levodopa in a Single Dose Cross-over Comparison Study
Baseline characteristics by cohort
| Measure |
B-Parcopa Arm First Then Crossover to Carbidopa/Levodopa Arm
n=10 Participants
Parcopa: at subjects current stable dose of comparator
|
A-Carbidopa/Levodopa Arm Then Crossover to Parcopa Arm
n=10 Participants
carbidopa-levodopa at subjects current stable dose
|
Total
n=20 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
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: first dose of day for each armTime to "on" state (benefit with regard to mobility, stiffness and slowness) with parcopa versus carbidopa/levodopa immediate release compound. This measurement is compared between Parcopa and carbidopa/levodopa wit the first morning dose of each intervention. Study duration was 2 days.
Outcome measures
| Measure |
B-Parcopa Arm
n=20 Participants
Parcopa: at subjects current stable dose of comparator
|
A-Carbidopa/Levodopa Arm
n=20 Participants
carbidopa-levodopa at subjects current stable dose
|
|---|---|---|
|
Measurement of Time in Minutes From When a Patient Was in a Clinical "Off" State, Took Their Medication and Went Into a Clinical "on" State
|
23.9 minutes
Standard Deviation 9.9
|
28.5 minutes
Standard Deviation 19.4
|
Adverse Events
B-Parcopa Arm
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
A-Carbidopa/Levodopa Arm
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
B-Parcopa Arm
n=20 participants at risk
Parcopa: at subjects current stable dose of comparator
|
A-Carbidopa/Levodopa Arm
n=20 participants at risk
carbidopa-levodopa at subjects current stable dose
|
|---|---|---|
|
General disorders
dyskinesia
|
5.0%
1/20 • Number of events 1 • 2 day, double blind crossover study
|
0.00%
0/20 • 2 day, double blind crossover study
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/20 • 2 day, double blind crossover study
|
10.0%
2/20 • Number of events 2 • 2 day, double blind crossover study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place