Trial Outcomes & Findings for Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole (NCT NCT03250117)
NCT ID: NCT03250117
Last Updated: 2023-05-06
Results Overview
Area under the plasma drug concentration-time curve of ropinirole
TERMINATED
PHASE1/PHASE2
6 participants
0-24 hours
2023-05-06
Participant Flow
Of 6 screened patients, 3 did not meet eligibility criteria for cohort assignment.
Participant milestones
| Measure |
Cohort 1
Requip; One Ropinirole Implant
|
Cohort 2
Requip; Two Ropinirole Implants
|
Cohort 3
Requip; Three Ropinirole Implants
|
Cohort 4
Requip; Four Ropinirole Implants
|
|---|---|---|---|---|
|
Requip IR [7-10 Days]
STARTED
|
3
|
0
|
0
|
0
|
|
Requip IR [7-10 Days]
COMPLETED
|
3
|
0
|
0
|
0
|
|
Requip IR [7-10 Days]
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Ropinirole Implant 12 Weeks
STARTED
|
3
|
0
|
0
|
0
|
|
Ropinirole Implant 12 Weeks
COMPLETED
|
2
|
0
|
0
|
0
|
|
Ropinirole Implant 12 Weeks
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
Requip; One Ropinirole Implant
|
Cohort 2
Requip; Two Ropinirole Implants
|
Cohort 3
Requip; Three Ropinirole Implants
|
Cohort 4
Requip; Four Ropinirole Implants
|
|---|---|---|---|---|
|
Ropinirole Implant 12 Weeks
At request of Sponsor, regulatory agencies, or the IRB
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole
Baseline characteristics by cohort
| Measure |
Cohort 1
n=3 Participants
Requip; One Ropinirole Implant
|
|---|---|
|
Age, Continuous
|
52.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 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
|
1 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
MDS-UPDRS Total Score
|
60.7 units on a scale
n=5 Participants
|
|
Awake Time "On"
|
11.54 hours
n=5 Participants
|
|
Awake Time "Off"
|
5.02 hours
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-24 hoursPopulation: Subjects who received at least 1 ropinirole implant and for whom at least 1 PK parameter of interest can be calculated were to be included in this analysis. Analysis not performed due to insufficient representative samples from each cohort.
Area under the plasma drug concentration-time curve of ropinirole
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 0-12 weeksPopulation: Subjects who received a least 1 ropinirole implant
Safety and tolerability of ropinirole implant(s) presented as the total number of adverse events experienced by the analysis population.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Requip; One Ropinirole Implant
|
|---|---|
|
Total Number of Adverse Events Across Participants
|
4 Events
|
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: Subjects who received at least 1 ropinirole implant and for whom at least 1 PK parameter of interest can be calculated were to be included in this analysis. Analysis not performed due to insufficient representative samples from each cohort.
Area under the plasma drug concentration-time curve of N-despropyl ropinirole
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0-24 hoursPopulation: Subjects who received at least 1 ropinirole implant and for whom at least 1 PK parameter of interest can be calculated were to be included in this analysis. Analysis not performed due to insufficient representative samples from each cohort.
Area under the plasma drug concentration-time curve of 7-hydroxy ropinirole
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8 and 12Population: Subjects who receive at least 1 ropinirole implant and complete at least 1 post-baseline efficacy assessment. Three subjects were in the analysis population at Week 4. Two subjects were in the analysis population at Weeks 8 and 12.
Efficacy of ropinirole implants presented as the mean change from baseline in MDS-UPDRS total score. Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Scale \[MDS-UPDRS\] is a questionnaire and examination rating motor and non-motor experiences, and motor complications. Score is summed to range from 0 to 272. Higher score indicates more severe symptoms/outcome.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Requip; One Ropinirole Implant
|
|---|---|
|
Mean Change From Baseline in MDS-UPDRS Total Score
Week 4
|
4.0 units on a scale
Standard Error 3.28
|
|
Mean Change From Baseline in MDS-UPDRS Total Score
Week 8
|
10.6 units on a scale
Standard Error 13.42
|
|
Mean Change From Baseline in MDS-UPDRS Total Score
Week 12
|
7.3 units on a scale
Standard Error 4.04
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12Population: Subjects who receive at least 1 ropinirole implant and complete at least 1 post-baseline efficacy assessment. Three subjects were in the analysis population for Weeks 1-6. Two subjects were in the analysis population for Weeks 8-12.
Efficacy of ropinirole implants presented as mean change from baseline of awake time "on". Diaries were completed for 2 consecutive days prior to the visit, used to record motor state in half-hour intervals over a 24-hour period (during waking hours). "On" refers to when medication is providing benefit with regard to mobility, slowness and stiffness, regardless of dyskinesia. Daily totals for waking hours were normalized to a 16-hour waking day and averaged across the 2 days.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Requip; One Ropinirole Implant
|
|---|---|
|
Mean Change From Baseline of Awake Time "On"
Week 2
|
1.11 hours
Standard Error 0.457
|
|
Mean Change From Baseline of Awake Time "On"
Week 3
|
1.70 hours
Standard Error 0.908
|
|
Mean Change From Baseline of Awake Time "On"
Week 1
|
0.80 hours
Standard Error 1.078
|
|
Mean Change From Baseline of Awake Time "On"
Week 4
|
0.77 hours
Standard Error 0.608
|
|
Mean Change From Baseline of Awake Time "On"
Week 6
|
0.66 hours
Standard Error 1.175
|
|
Mean Change From Baseline of Awake Time "On"
Week 8
|
0.11 hours
Standard Error 1.344
|
|
Mean Change From Baseline of Awake Time "On"
Week 10
|
0.93 hours
Standard Error 0.756
|
|
Mean Change From Baseline of Awake Time "On"
Week 12
|
0.58 hours
Standard Error 1.101
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12Population: Subjects who receive at least 1 ropinirole implant and complete at least 1 post-baseline efficacy assessment. Three subjects were in the analysis population for Weeks 1-6. Two subjects were in the analysis population for Weeks 8-12.
Efficacy of ropinirole implants presented as mean change from baseline of awake time "Off". Diaries were completed for 2 consecutive days prior to the visit, used to record motor state in half-hour intervals over a 24-hour period (during waking hours). "Off" refers to when medication has worn off and is no longer providing benefit with regard to mobility, slowness and stiffness. Daily totals for waking hours were normalized to a 16-hour waking day and averaged across the 2 days
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Requip; One Ropinirole Implant
|
|---|---|
|
Mean Change From Baseline of Awake Time "Off"
Week 1
|
-1.36 hours
Standard Error 0.974
|
|
Mean Change From Baseline of Awake Time "Off"
Week 2
|
-1.67 hours
Standard Error 0.921
|
|
Mean Change From Baseline of Awake Time "Off"
Week 3
|
-2.26 hours
Standard Error 1.062
|
|
Mean Change From Baseline of Awake Time "Off"
Week 4
|
-1.33 hours
Standard Error 1.094
|
|
Mean Change From Baseline of Awake Time "Off"
Week 6
|
-1.22 hours
Standard Error 1.506
|
|
Mean Change From Baseline of Awake Time "Off"
Week 8
|
-0.83 hours
Standard Error 2.068
|
|
Mean Change From Baseline of Awake Time "Off"
Week 10
|
-1.77 hours
Standard Error 1.598
|
|
Mean Change From Baseline of Awake Time "Off"
Week 12
|
-1.43 hours
Standard Error 1.943
|
Adverse Events
Cohort 1
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=3 participants at risk
Requip; One Ropinirole Implant
|
|---|---|
|
General disorders
Implant site reaction
|
33.3%
1/3 • Number of events 1 • From signing of the ICF until 30 days following study drug treatment discontinuation, up to 22 weeks.
Subjects assessed for AEs at every visit, routine collection of safety labs, and spontaneous self-reporting.
|
|
Nervous system disorders
Freezing phenomenon
|
33.3%
1/3 • Number of events 1 • From signing of the ICF until 30 days following study drug treatment discontinuation, up to 22 weeks.
Subjects assessed for AEs at every visit, routine collection of safety labs, and spontaneous self-reporting.
|
|
Psychiatric disorders
Affect lability
|
33.3%
1/3 • Number of events 1 • From signing of the ICF until 30 days following study drug treatment discontinuation, up to 22 weeks.
Subjects assessed for AEs at every visit, routine collection of safety labs, and spontaneous self-reporting.
|
|
Psychiatric disorders
Hallucination, visual
|
33.3%
1/3 • Number of events 1 • From signing of the ICF until 30 days following study drug treatment discontinuation, up to 22 weeks.
Subjects assessed for AEs at every visit, routine collection of safety labs, and spontaneous self-reporting.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor has rights to first publication of results unless waived by Sponsor. PIs may publish following Sponsor first publication or 18 months after conclusion, abandonment or termination of study. Sponsor to review proposed publications prior to public release and can embargo results for up to 60 days from the time submitted to the Sponsor for review and may remove any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER