Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) Patients
- Conditions
- Parkinson Disease
- Interventions
- Registration Number
- NCT01191944
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of this trial is to evaluate non-inferiority of pramipexole Extended release to Immediate release at 18 weeks on the primary efficacy endpoint (Unified Parkinson's Disease Rating Scale II+III) in Chinese PD patients who can be concomitantly treated with Levodopa .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 475
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description pramipexole Extended release pramipexole extended release tablet subjects will receive 0.375mg once a day to 4.5mg once a day depending on investigator's judgement pramipexole Immediate release pramipexole immediate release tablet subjects will receive 0.125mg three times a day to 1.0mg three times a day depending on investigator's judgement
- Primary Outcome Measures
Name Time Method Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18 Baseline and week 18 UPDRS total score ranges from 0 (best) to 160 (worst) and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Percentage On-time Without or With Non-troublesome Dyskinesia at Week 18 Baseline and week 18 Percentage on-time without or with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.
Responder in Percentage Off-time During Waking Hours at Week 18 Baseline and week 18 Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Responders were defined as patients with at least a 20 percent improvement relative to baseline.
Change From Baseline in Percentage On-time Without Dyskinesia at Week 18 Baseline and week 18 Percentage on-time without Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.
Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18 Baseline and week 18 Percentage on-time with troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as troublesome if it interfered with function or caused meaningful discomfort. Decrease in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.
Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18 Baseline and week 18 Percentage on-time with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.
Change From Baseline in Percentage Off-time During Waking Hours at Week 18 Baseline and week 18 Percentage off-time during waking hours based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.
Change From Baseline in Duration of Off-time During Waking Hours at Week 18 Baseline and week 18 Duration of off-time during waking hours based on patient diary data. Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.
Change From Baseline in Duration of On-time Without Dyskinesia at Week 18 Baseline and week 18 Duration of on-time without Dyskinesia based on patient diary data. On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.
Change From Baseline in Duration of On-time With Non-troublesome Dyskinesia at Week 18 Baseline and week 18 Duration on-time with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.
Change From Baseline in Duration of On-time Without or With Non-troublesome Dyskinesia at Week 18 Baseline and week 18 Duration of on-time without Dyskinesia or with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.
Patient Global Impressions of Improvement (PGI-I) Responder at Week 18 18 weeks The PGI-I scale is a patient-rated instrument which was used to measure the improvement of a patients PD symptoms throughout the study. Ranging from 1 point=very much better to 7 points=very much worse. Responders were defined as patients having score 1 or 2 (at least much better) when comparing the past week to the assessment at baseline.
Responder in UPDRS Parts II+III Score at Week 18 Baseline and week 18 Responders were defined as patients with at least a 20 percent improvement of UPDRS II+III score relative to baseline. UPDRS II+III ranges 0-160 scores from best to worst and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108).
Levodopa (L-Dopa) Dose Change During the Study 18 weeks Although the number of patients who began the study with concomitant L-dopa supplementation and required a change in dosage was not analysed for this study, the change from baseline in L-dopa dose is presented.
Change From Baseline in Duration of On-time With Troublesome Dyskinesia at Week 18 Baseline and week 18 Duration of on-time with troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as troublesome if it interfered with function or caused meaningful discomfort. Decrease in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.
Clinical Global Impression of Improvement (CGI-I) Responder at Week 18 18 weeks CGI-I was used to assess the overall status of Parkinsons disease (PD) after interviewing the patient about the various aspects of the PD and after evaluating adverse events and concomitant treatments. Ranging from 1 point=very much improved to 7 points=very much worse. Responders were defined as patients having score 1 or 2 (at least much improved) when comparing the past week to the assessment at baseline.
Change From Baseline in UPDRS II Score Separately at Week 18 Baseline and week 18 UPDRS Part II (activities of daily living) ranges from 0 to 52. Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.
Change From Baseline in UPDRS III Score Separately at Week 18 Baseline and week 18 UPDRS Part III (motor examination) ranges from 0 to 108. Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.
Levodopa (L-Dopa) Introduction During the Study 18 weeks Number of patients without concomitant L-Dopa treatment at baseline which required L-Dopa supplementation during the study.
Trial Locations
- Locations (20)
248.671.86013 Boehringer Ingelheim Investigational Site
🇨🇳Chongqing, China
248.671.86012 Boehringer Ingelheim Investigational Site
🇨🇳Chengdu, China
248.671.86014 Boehringer Ingelheim Investigational Site
🇨🇳Chongqing, China
248.671.86005 Boehringer Ingelheim Investigational Site
🇨🇳Jinan, China
248.671.86008 Boehringer Ingelheim Investigational Site
🇨🇳Guangzhou, China
248.671.86009 Boehringer Ingelheim Investigational Site
🇨🇳Guangzhou, China
248.671.86018 Boehringer Ingelheim Investigational Site
🇨🇳Hangzhou, China
248.671.86001 Boehringer Ingelheim Investigational Site
🇨🇳Shanghai, China
248.671.86010 Boehringer Ingelheim Investigational Site
🇨🇳Shanghai, China
248.671.86003 Boehringer Ingelheim Investigational Site
🇨🇳Shanghai, China
248.671.86019 Boehringer Ingelheim Investigational Site
🇨🇳Suzhou, China
248.671.86015 Boehringer Ingelheim Investigational Site
🇨🇳Wuhan, China
248.671.86004 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
248.671.86017 Boehringer Ingelheim Investigational Site
🇨🇳Hangzhou, China
248.671.86011 Boehringer Ingelheim Investigational Site
🇨🇳Shenyang, China
248.671.86016 Boehringer Ingelheim Investigational Site
🇨🇳Wuhan, China
248.671.86006 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
248.671.86007 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
248.671.86020 Boehringer Ingelheim Investigational Site
🇨🇳Beijing, China
248.671.86002 Boehringer Ingelheim Investigational Site
🇨🇳Nanjing, China