Trial Outcomes & Findings for Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily (NCT NCT00986245)

NCT ID: NCT00986245

Last Updated: 2013-09-09

Results Overview

Patient preference between once-daily and twice-daily regimen

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 82 participants
• Primary outcome timeframe: After 16 weeks or at last visit for early completion
• Results posted on: 2013-09-09

Participant Flow

The first subject was enrolled in September 2009 and the last subject completed the study in December 2010.

A total of 82 patients with PD were enrolled in this study at two centers in Seoul, Korea.

Participant milestones

Measure	Ropinirole PR-Once Daily First, Then Twice Daily Ropinirole prolonged release(PR) once daily in first intervention period and twice daily in second intervention period (without washout period)	Ropinirole PR-Twice Daily First, Then Once Daily Ropinirole prolonged release(PR) twice daily in first intervention period and once daily in second intervention period (without washout period)
First Intervention STARTED	41	41
First Intervention COMPLETED	31	33
First Intervention NOT COMPLETED	10	8
Second Intervention STARTED	31	33
Second Intervention COMPLETED	29	32
Second Intervention NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Ropinirole PR-Once Daily First, Then Twice Daily Ropinirole prolonged release(PR) once daily in first intervention period and twice daily in second intervention period (without washout period)	Ropinirole PR-Twice Daily First, Then Once Daily Ropinirole prolonged release(PR) twice daily in first intervention period and once daily in second intervention period (without washout period)
First Intervention Poor compliance	8	4
First Intervention Lack of Efficacy	1	2
First Intervention Withdrawal by Subject	0	1
First Intervention Protocol Violation	0	1
First Intervention Out of indication	1	0
Second Intervention Poor compliance	1	0
Second Intervention Lost to Follow-up	1	0
Second Intervention Protocol Violation	0	1

Baseline Characteristics

Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily

Baseline characteristics by cohort

Measure	Entire Study Population n=82 Participants Includes groups randomized to receive once daily first and twice daily first.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants
Age, Categorical >=65 years	31 Participants n=5 Participants
Age Continuous	61.8 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Region of Enrollment Korea, Republic of	82 participants n=5 Participants

PRIMARY outcome

Timeframe: After 16 weeks or at last visit for early completion

Population: Primary outcome measure was the preference of the subjects between once-daily versus twice-daily of RPR at the completion or at early completion after crossover. 61 of participants completing period with study intervention.

Patient preference between once-daily and twice-daily regimen

Outcome measures

Measure	Once-daily n=61 Participants Once-daily preferred group	Twice-daily n=61 Participants Twice-daily preferred group	No Preference n=61 Participants No preference group
Patient Preference	17 participants	31 participants	13 participants

SECONDARY outcome

Timeframe: 8 weeks for each arm or at last visit

Population: Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. Once-daily or Twice-daily arm means clinical variables measured in once-daily or twice-daily regimen, respectively.

Unified Parkinson's disease rating scale (UPDRS) motor scale after 8 weeks in each arm or at last visit for early completion.

UPDRS part 3 is motor scale for parkinson's disease. Range: 0~108 Higher values represent more severe motor symptoms of parkinsonism.

Outcome measures

Measure	Once-daily n=61 Participants Once-daily preferred group	Twice-daily n=61 Participants Twice-daily preferred group	No Preference No preference group
Unified Parkinson's Disease Rating Scale, Part 3	17.5 units on a scale Standard Deviation 8.2	17.1 units on a scale Standard Deviation 8.9	—

SECONDARY outcome

Timeframe: 8 weeks for each arm or at last visit

Population: Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. Once-daily or twice-daily arm means clinical variables measured in once-daily or twice-daily regimen, respectively.

Hoehn and Yahr(HY) stage for parkinsonism after 8 weeks in each arm or at last visit for early completion Range: 0~5 Higher values represent more severe parkinsonism

Outcome measures

Measure	Once-daily n=61 Participants Once-daily preferred group	Twice-daily n=61 Participants Twice-daily preferred group	No Preference No preference group
Hoehn and Yahr Stage	2.1 Scores on a scale Standard Deviation 0.5	2.1 Scores on a scale Standard Deviation 0.6	—

SECONDARY outcome

Timeframe: 8 weeks for each arm or at last visit

Population: Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.

Sleep questionnaire 1 for "Overall quality of sleep" Visual analogue scale: 0~10 Higher values represent worse overall sleep quality.

Outcome measures

Measure	Once-daily n=61 Participants Once-daily preferred group	Twice-daily n=61 Participants Twice-daily preferred group	No Preference No preference group
Overall Quality of Sleep	2.9 units on a scale Standard Deviation 2.6	3.2 units on a scale Standard Deviation 2.5	—

SECONDARY outcome

Timeframe: 8 weeks for each arm or at last visit

Population: Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.

Sleep questionnaire 2 for "Nocturnal off-symptoms" Visual analogue scale: 0~10 Higher values represent worse nocturnal off-symptoms.

Outcome measures

Measure	Once-daily n=61 Participants Once-daily preferred group	Twice-daily n=61 Participants Twice-daily preferred group	No Preference No preference group
Nocturnal Off-symptoms	2.9 units on a scale Standard Deviation 3.2	3.1 units on a scale Standard Deviation 3.2	—

SECONDARY outcome

Timeframe: 8 weeks for each arm or at last visit

Population: Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.

Sleep questionnaire 3 for "early morning off symptoms" Visual analogue scale: 0~10 Higher values represent worse early morning off symptoms.

Outcome measures

Measure	Once-daily n=61 Participants Once-daily preferred group	Twice-daily n=61 Participants Twice-daily preferred group	No Preference No preference group
Early Morning Off Symptoms	2.5 units on a scale Standard Deviation 3.3	2.9 units on a scale Standard Deviation 3.2	—

SECONDARY outcome

Timeframe: 8 weeks in each arm or at last visit for early completion

Population: Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.

Epworth sleep scale after 8 weeks in each arm or at last visit for early completion.

Range: 0~24 Higher values represent worse daytime-sleepiness.

Outcome measures

Measure	Once-daily n=61 Participants Once-daily preferred group	Twice-daily n=61 Participants Twice-daily preferred group	No Preference No preference group
Epworth Sleep Scale	6.3 units on a scale Standard Deviation 5.2	6.4 units on a scale Standard Deviation 4.8	—

SECONDARY outcome

Timeframe: 8 weeks for each arm or at last visit

Population: Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.

Compliances after 8 weeks in each arm or at last visit for early completion. Compliance was calcuated by the percentage of used medication.

Outcome measures

Measure	Once-daily n=61 Participants Once-daily preferred group	Twice-daily n=61 Participants Twice-daily preferred group	No Preference No preference group
Compliance	98.4 percentage of used medication Standard Deviation 3.9	97.6 percentage of used medication Standard Deviation 3.7	—

SECONDARY outcome

Timeframe: After 8 weeks in each arm or at last visit for early completion

Population: Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively.

Patients who have adverse events

Outcome measures

Measure	Once-daily n=61 Participants Once-daily preferred group	Twice-daily n=61 Participants Twice-daily preferred group	No Preference No preference group
Adverse Events	33 participants	28 participants	—

SECONDARY outcome

Timeframe: After 8 weeks in each arm or at last visit for early completion

Population: The number of patient who completed the study and answered the questionnaire for global impression.

Patients who have global impression for improvement for each dosing.

Outcome measures

Measure	Once-daily n=61 Participants Once-daily preferred group	Twice-daily n=61 Participants Twice-daily preferred group	No Preference No preference group
Patients Who Have Global Impression for Improvement	32 participants	42 participants	—

SECONDARY outcome

Timeframe: After 8 weeks in each arm or at last visit for early completion

Population: The number of patient who completed the study and answered the questionnaire for global impression to motor fluctuation duration.

Patients who have global impression for improvement to duration of motor fluctuation

Outcome measures

Measure	Once-daily n=61 Participants Once-daily preferred group	Twice-daily n=61 Participants Twice-daily preferred group	No Preference No preference group
Patients Who Have Global Impression for Improvement to Duration of Motor Fluctuation	27 participants	38 participants	—

SECONDARY outcome

Timeframe: After 8 weeks in each arm or at last visit for early completion

Population: The number of patient who completed the study and answered the questionnaire for global impression to motor fluctuation severity.

Patients who have global impression for improvement to severity of motor fluctuation compared

Outcome measures

Measure	Once-daily n=61 Participants Once-daily preferred group	Twice-daily n=61 Participants Twice-daily preferred group	No Preference No preference group
Patients Who Have Global Impression for Improvement to Severity of Motor Fluctuation	28 participants	34 participants	—

SECONDARY outcome

Timeframe: After 8 weeks in each arm or at last visit for early completion

Population: The number of patient who completed the study and answered the questionnaire for global impression to dyskinesia duration.

Patients who have global impression for improvement to duration of dyskinesia compared

Outcome measures

Measure	Once-daily n=61 Participants Once-daily preferred group	Twice-daily n=61 Participants Twice-daily preferred group	No Preference No preference group
Patients Who Have Global Impression for Improvement to Duration of Dyskinesia	13 participants	16 participants	—

SECONDARY outcome

Timeframe: After 8 weeks in each arm or at last visit for early completion

Population: The number of patient who completed the study and answered the questionnaire for global impression to dyskinesia severity.

Patients who have Global Impression for Improvement to Severity of Dyskinesia compared

Outcome measures

Measure	Once-daily n=61 Participants Once-daily preferred group	Twice-daily n=61 Participants Twice-daily preferred group	No Preference No preference group
Patients Who Have Global Impression for Improvement to Severity of Dyskinesia	16 participants	15 participants	—

Adverse Events

Once-daily of Ropinirole PR

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Twice-daily of Ropinirole PR

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Once-daily of Ropinirole PR n=61 participants at risk Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.	Twice-daily of Ropinirole PR n=61 participants at risk Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
Gastrointestinal disorders Nausea	14.8% 9/61 • Number of events 9 • 8 weeks for each arm or at last visit	11.5% 7/61 • Number of events 7 • 8 weeks for each arm or at last visit
General disorders Dizziness	4.9% 3/61 • Number of events 3 • 8 weeks for each arm or at last visit	6.6% 4/61 • Number of events 4 • 8 weeks for each arm or at last visit
Nervous system disorders Somnolence	1.6% 1/61 • Number of events 1 • 8 weeks for each arm or at last visit	3.3% 2/61 • Number of events 2 • 8 weeks for each arm or at last visit
Nervous system disorders Headache	4.9% 3/61 • Number of events 3 • 8 weeks for each arm or at last visit	1.6% 1/61 • Number of events 1 • 8 weeks for each arm or at last visit
Gastrointestinal disorders Constipation	32.8% 20/61 • Number of events 20 • 8 weeks for each arm or at last visit	31.1% 19/61 • Number of events 19 • 8 weeks for each arm or at last visit
Gastrointestinal disorders Dyspepsia	11.5% 7/61 • Number of events 7 • 8 weeks for each arm or at last visit	9.8% 6/61 • Number of events 6 • 8 weeks for each arm or at last visit
Gastrointestinal disorders Dry mouth	4.9% 3/61 • Number of events 3 • 8 weeks for each arm or at last visit	4.9% 3/61 • Number of events 3 • 8 weeks for each arm or at last visit
Nervous system disorders Aggravation of vivid dream or REM sleep behavior disorder	4.9% 3/61 • Number of events 3 • 8 weeks for each arm or at last visit	3.3% 2/61 • Number of events 2 • 8 weeks for each arm or at last visit
Psychiatric disorders Anxiety	1.6% 1/61 • Number of events 1 • 8 weeks for each arm or at last visit	1.6% 1/61 • Number of events 1 • 8 weeks for each arm or at last visit

Additional Information

BS Jeon

Seoul National University Hospital

Phone: 82-2-2072-2876

Email: brain@snu.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place