Trial Outcomes & Findings for Impact of Switching to Continuous Release Dopamine Agonists (NCT NCT00465452)

NCT ID: NCT00465452

Last Updated: 2025-05-16

Results Overview

The Unified Parkinson's Disease Rating Scale (UPDRS), parts 3 (motor performance) and 4 (disability) are standardized and validated measures of various symptoms of Parkinson's disease - total scores range from 0 to 148 with lower scores representing better Parkinson symptom control and higher scores representing worse symptoms of Parkinson's.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

11 participants

Primary outcome timeframe

initial visit and at end of study 24 weeks

Results posted on

2025-05-16

Participant Flow

Patients from our outpatient clinic with Parkinson's disease receiving regular pramipexole as one of their treatments and experiencing one or more of the side effects measured in this study.

Participant milestones

Participant milestones
Measure	Continuous Release Dopamine Agonists Patients were switched from regular pramipexole to extended release ropinirole
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Continuous Release Dopamine Agonists Patients were switched from regular pramipexole to extended release ropinirole
Overall Study Adverse Event	1

Baseline Characteristics

Impact of Switching to Continuous Release Dopamine Agonists

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous Release Dopamine Agonist n=11 Participants Patients were switched from regular pramipexole to extended release ropinirole
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	58 years STANDARD_DEVIATION 8.55 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: initial visit and at end of study 24 weeks

Population: Patients with Parkinson's disease receiving regular pramipexole as one of their treatments and experiencing one or more of the side effects measured in this study.

The Unified Parkinson's Disease Rating Scale (UPDRS), parts 3 (motor performance) and 4 (disability) are standardized and validated measures of various symptoms of Parkinson's disease - total scores range from 0 to 148 with lower scores representing better Parkinson symptom control and higher scores representing worse symptoms of Parkinson's.

Outcome measures

Outcome measures
Measure	Continuous Release Dopamine Agonist n=10 Participants Patients were switched from regular pramipexole to extended release ropinirole
Unified Parkinson's Disease Rating Scale (UPDRS), Parts 3 (Motor Performance) and 4 (Disability). UPDRS Part 3 Baseline	19.2 score on a scale Interval 0.0 to 108.0
Unified Parkinson's Disease Rating Scale (UPDRS), Parts 3 (Motor Performance) and 4 (Disability). UPDRS Part 3 Week 24	17.6 score on a scale Interval 0.0 to 108.0
Unified Parkinson's Disease Rating Scale (UPDRS), Parts 3 (Motor Performance) and 4 (Disability). UPDRS Part 4 Baseline	5.1 score on a scale Interval 0.0 to 24.0
Unified Parkinson's Disease Rating Scale (UPDRS), Parts 3 (Motor Performance) and 4 (Disability). UPDRS Part 4 Week 24	2.9 score on a scale Interval 0.0 to 24.0

PRIMARY outcome

Timeframe: initial visit and at end of study 24 weeks

The Mini-Mental Status Exam (MMSE) and the Clock Drawing Test (CDT) are standardized and validated measures of cognitive function. The Patient Health Questionnaire (PHQ-9) is a standardized and validated measure of quality of life. The Mini-Mental Status Exam (MMSE) scale is 0-30 with higher numbers indicating improvement. The Clock Drawing Test (CDT) range is 0-10 with higher numbers indicating improvement. the PHQ scale is 0-27 with lower numbers indicating improved outcome.

Outcome measures

Outcome measures
Measure	Continuous Release Dopamine Agonist n=10 Participants Patients were switched from regular pramipexole to extended release ropinirole
Mini-Mental Status Exam (MMSE), the Clock Drawing Test (CDT), the Patient Health Questionnaire (PHQ-9). MMSE Baseline	28.9 score on a scale Interval 0.0 to 30.0
Mini-Mental Status Exam (MMSE), the Clock Drawing Test (CDT), the Patient Health Questionnaire (PHQ-9). MMSE 24 Weeks	29.1 score on a scale Interval 0.0 to 30.0
Mini-Mental Status Exam (MMSE), the Clock Drawing Test (CDT), the Patient Health Questionnaire (PHQ-9). Clock Drawing Test Baseline	9.8 score on a scale Interval 0.0 to 10.0
Mini-Mental Status Exam (MMSE), the Clock Drawing Test (CDT), the Patient Health Questionnaire (PHQ-9). Clock Drawing Test 24 Weeks	9.4 score on a scale Interval 0.0 to 10.0
Mini-Mental Status Exam (MMSE), the Clock Drawing Test (CDT), the Patient Health Questionnaire (PHQ-9). Patient Health Questionnaire Baseline	7.5 score on a scale Interval 0.0 to 27.0
Mini-Mental Status Exam (MMSE), the Clock Drawing Test (CDT), the Patient Health Questionnaire (PHQ-9). Patient Health Questionnaire Week 24	6.2 score on a scale Interval 0.0 to 27.0

PRIMARY outcome

Timeframe: initial visit and at end of study 24 weeks

Population: Patients with Parkinson's disease receiving regular pramipexole as one of their treatments and experiencing one or more of the side effects measured in this study.

The assessment of ankle edema was considered to be a marker of improvement possibly seen in patients who switched from regular pramipexole to extended release ropinirole. .

Outcome measures

Outcome measures
Measure	Continuous Release Dopamine Agonist n=10 Participants Patients were switched from regular pramipexole to extended release ropinirole
Peripheral Edema, as Measured by Quantitative Assessment of Ankle Edema Ankle Edema Baseline	225.11 mm Interval 207.7 to 265.2
Peripheral Edema, as Measured by Quantitative Assessment of Ankle Edema Ankle Edema Week 24	224.38 mm Interval 203.6 to 262.7

PRIMARY outcome

Timeframe: initial visit and at end of study 24 weeks

Population: Patients with Parkinson's disease receiving regular pramipexole as one of their treatments and experiencing one or more of the side effects measured in this study.

The patient satisfaction/preference (Patient Satisfaction Questionnaire - PS) scores vary from 0-10 with higher scores indicating greater satisfaction with the med change.

Outcome measures

Outcome measures
Measure	Continuous Release Dopamine Agonist n=10 Participants Patients were switched from regular pramipexole to extended release ropinirole
Patient Satisfaction Questionnaire Patient Satisfaction Questionnaire Baseline	0.7 score on a scale Interval 0.0 to 10.0
Patient Satisfaction Questionnaire Patient Satisfaction Questionnaire Week 24	5.2 score on a scale Interval 0.0 to 10.0

PRIMARY outcome

Timeframe: initial visit and at end of study 24 weeks

Population: Patients with Parkinson's disease receiving regular pramipexole as one of their treatments and experiencing one or more of the side effects measured in this study.

The Improvement in quality of life (Parkinson's Disease Questionnaire - PDQ-39 - is a standardized and validated measure of patient quality of life ranging in score from 0-100 with lower scores indicating improvement versus higher scores indicating worsening of QOL.

Outcome measures

Outcome measures
Measure	Continuous Release Dopamine Agonist n=10 Participants Patients were switched from regular pramipexole to extended release ropinirole
Parkinson's Disease Questionnaire (PDQ-39) PDQ-39 Baseline	32.3 score on a scale Interval 0.0 to 100.0
Parkinson's Disease Questionnaire (PDQ-39) PDQ-39 Week 24	31.1 score on a scale Interval 0.0 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: initial visit and at end of study 24 weeks

Population: Patients with Parkinson's disease receiving regular pramipexole as one of their treatments and experiencing one or more of the side effects measured in this study.

Epworth sleepiness scale is a standardized and validated measure of patient's daytime sleepiness. The range of scores is from 0-24 with lower scores representing minimal to no sleepiness and higher scores indicating excessive daytime somnolence.

Outcome measures

Outcome measures
Measure	Continuous Release Dopamine Agonist n=10 Participants Patients were switched from regular pramipexole to extended release ropinirole
Epworth Sleepiness Scale (ESS). Epworth sleepiness scale Baseline	18.2 score on a scale Interval 0.0 to 24.0
Epworth Sleepiness Scale (ESS). Epworth sleepiness scale Week 24	11.9 score on a scale Interval 0.0 to 24.0

Adverse Events

Continuous Release Dopamine Agonist

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Continuous Release Dopamine Agonist n=11 participants at risk Patients were switched from regular pramipexole to extended release ropinirole
General disorders General pains	100.0% 11/11 • Number of events 68 • 2 years
Cardiac disorders Hypertension	9.1% 1/11 • Number of events 1 • 2 years
Cardiac disorders Congestive Heart Failure	9.1% 1/11 • Number of events 1 • 2 years
Gastrointestinal disorders Gastrointestinal	63.6% 7/11 • Number of events 10 • 2 years
Injury, poisoning and procedural complications Injury	27.3% 3/11 • Number of events 6 • 2 years
Nervous system disorders Nervous System	90.9% 10/11 • Number of events 23 • 2 years
Psychiatric disorders Increased Compulsion	9.1% 1/11 • Number of events 2 • 2 years
Respiratory, thoracic and mediastinal disorders Upper Respiratory	45.5% 5/11 • Number of events 7 • 2 years
Skin and subcutaneous tissue disorders Skin	9.1% 1/11 • Number of events 4 • 2 years

Additional Information

Julia Spears

The University of Toledo

Phone: 419-383-6728

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place