A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period
- Conditions
- Parkinson Disease
- Interventions
- Registration Number
- NCT00560508
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of this trial is to investigate the safety, tolerability, trough plasma concentration, and efficacy of pramipexole ER in comparison with those of pramipexole IR administrated orally for 12 weeks in patients with PD on levodopa (L-DOPA) therapy (the double-blind period). The double-blind period will be followed by the open-label 52 week administration of pramipexole ER to evaluate the long term safety and efficacy (the open-label period).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pramipexole Extended Release Pramipexole Extended Release patient to receive a tablet containing 0.375 mg Pramipexole ER once a day plus containing 0.125 mg Pramipexole IR placebo twice a day -\> a tablet containing 1.5 mg Pramipexole ER three times daily (TID) plus 0.5 mg Pramipexole IR placebo TID Pramipexole Immediate Release Pramipexole Immediate Release patient to receive a tablet containing 0.125 mg Pramipexole IR twice a day plus containing 0.375 mg Pramipexole ER placebo once a day -\> a tablet containing 0.5 mg Pramipexole IR three times daily (TID) plus 1.5 mg Pramipexole ER placebo TID
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Experienced Adverse Events 12 weeks An adverse event is defined as any untoward medical occurrence
- Secondary Outcome Measures
Name Time Method Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score baseline and after 12 weeks treatment UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Change From Baseline in Percentage Off-time baseline and after 12 weeks treatment Percentage off-time during waking hours in the last two days 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).
Change From Baseline in Percentage On-time Without Dyskinesia baseline and after 12 weeks treatment Percentage on-time without dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia baseline and after 12 weeks treatment Percentage on-time with non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0(worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia baseline and after 12 weeks treatment Percentage on-time without dyskinesia or non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Change From Baseline in UPDRS Part II Score baseline and after 12 weeks treatment UPDRS Part II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS Part II at on and UPDRS Part II at off-period for each of the 13 activities.
Change From Baseline in UPDRS Part III Score baseline and after 12 weeks treatment UPDRS Part III ranging from 0 (normal) to 108 (severe). UPDRS Part III measures motor symptoms
Change From Baseline in UPDRS Part IV Score baseline and after 12 weeks treatment UPDRS Part IV ranging from 0 (normal) to 23 (severe). UPDRS Part IV measures complications of therapy
UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) baseline and after 12 weeks treatment Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse
Change From Baseline in L-dopa Daily Dose baseline and after 12 weeks treatment The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit.
Trough Plasma Concentration at Steady State at Visit 8 after pramipexole ER 4.5mg and IR 4.5mg treatment Geometric mean (gMean) was calculated for trough plasma concentrations of pramipexole at steady state after administration of pramipexole IR 4.5mg and pramipexole ER 4.5mg.
Change From Baseline in Percentage On-time With Troublesome Dyskinesia baseline and after 12 weeks treatment Percentage on-time with troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Responder Rate For Clinical Global Impression of Improvement (CGI-I) baseline and after 12 weeks treatment CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved)
Responder Rate For Patient Global Impression of Improvement (PGI-I) baseline and after 12 weeks treatment PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring of 1 or 2 (at least much better)
Change From Baseline in UPDRS Part I Score baseline and after 12 weeks treatment UPDRS Part I ranging from 0 (normal) to 16 (severe). UPDRS Part I measures Mentation, Behavior and Mood
Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase) Week 12 to Week 16 Clinical Global Impression of Improvement (CGI-I) at week 16 compared to patient's CGI-I status at week 12. CGI-I scores ranging from '1' (very much improved) to '7' (very much worse)
Dose Proportionality of Trough Plasma Concentration at Steady State After Pramipexole ER Treatment from Visit 1 to Visit 8 after pramipexole ER Dose proportionality of trough plasma concentrations at steady state is explored by using the power model that described the functional relationship between the dose and plasma concentration
Change From End of Double-Blind Period in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Dose Adjustment Phase) Week 12 to Week 16 UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms. Least square means and standard errors presented are from ANCOVA with factors treatment and covariate baseline.
Percentage of Patients With no Worsening of UPDRS Parts II+III Total Score by More Than 15% From Week 12 to Week 16 (Open-label: Dose Adjustment Phase) Week 12 to Week 16 Percentage of patients with no worsening of UPDRS Parts II+III Total Score by more than 15% from week 12 to week 16 (Open-label: Dose Adjustment Phase)
UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) (Open-label: Maintenance Phase) baseline and after 64 weeks treatment Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse
Change From Baseline in Percentage Off-time (Open-label: Maintenance Phase) baseline and after 64 weeks treatment Percentage off-time during waking hours in the last two days 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).
Change From Baseline in Percentage On-time Without Dyskinesia (Open-label: Maintenance Phase) baseline and after 64 weeks treatment Percentage on-time without dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia (Open-label Maintenance Phase) baseline and after 64 weeks treatment Percentage on-time with non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0(worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase) Week 12 to Week 16 Patient Global Impression of Improvement (PGI-I) at week 16 compared to patient's PGI-I status at week 12. PGI-I scores ranging from '1' (very much better) to '7' (very much worse).
Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Maintenance Phase) Baseline and after 64 weeks treatment UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia (Open-label Maintenance Phase) baseline and after 64 weeks treatment Percentage on-time without dyskinesia or non-troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Change From Baseline in Percentage On-time With Troublesome Dyskinesia (Open-label Maintenance Phase) baseline and after 64 weeks treatment Percentage on-time with troublesome dyskinesia during waking hours in the last two days based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Change From Baseline in L-dopa Daily Dose (Open-label Maintenance Phase) baseline and after 64 weeks treatment The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit.
Change From Baseline in UPDRS Part I Score (Open-label: Maintenance Phase) baseline and after 64 weeks treatment UPDRS Part I ranging from 0 (normal) to 16 (severe). UPDRS Part I measures Mentation, Behavior and Mood
Change From Baseline in UPDRS Part II Score (Open-label: Maintenance Phase) baseline and after 64 weeks treatment UPDRS Part II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS Part II at on and UPDRS Part II at off-period for each of the 13 activities.
Change From Baseline in UPDRS Part III Score (Open-label: Maintenance Phase) baseline and after 64 weeks treatment UPDRS Part III ranging from 0 (normal) to 108 (severe). UPDRS Part III measures motor symptoms
Change From Baseline in UPDRS Part IV Score (Open-label: Maintenance Phase) baseline and after 64 weeks treatment UPDRS Part IV ranging from 0 (normal) to 23 (severe). UPDRS Part IV measures complications of therapy
Trial Locations
- Locations (19)
248.610.020 Boehringer Ingelheim Investigational Site
🇯🇵Akita, Akita, Japan
248.610.019 Boehringer Ingelheim Investigational Site
🇯🇵Akashi, Hyogo, Japan
248.610.014 Boehringer Ingelheim Investigational Site
🇯🇵Fuchu, Tokyo, Japan
248.610.011 Boehringer Ingelheim Investigational Site
🇯🇵Fukuoka, Fukuoka, Japan
248.610.015 Boehringer Ingelheim Investigational Site
🇯🇵Iwamizawa,Hokkaido, Japan
248.610.012 Boehringer Ingelheim Investigational Site
🇯🇵Osaka, Osaka, Japan
248.610.002 Boehringer Ingelheim Investigational Site
🇯🇵Takamatsu, Kagawa, Japan
248.610.021 Boehringer Ingelheim Investigational Site
🇯🇵Kyoto, Kyoto, Japan
248.610.017 Boehringer Ingelheim Investigational Site
🇯🇵Asahikawa, Hokkaido, Japan
248.610.008 Boehringer Ingelheim Investigational Site
🇯🇵Kyoto, Kyoto, Japan
248.610.006 Boehringer Ingelheim Investigational Site
🇯🇵Aomori, Aomori, Japan
248.610.018 Boehringer Ingelheim Investigational Site
🇯🇵Asahikawa, Hokkaido, Japan
248.610.010 Boehringer Ingelheim Investigational Site
🇯🇵Morioka, Iwate, Japan
248.610.005 Boehringer Ingelheim Investigational Site
🇯🇵Okayama, Okayama, Japan
248.610.001 Boehringer Ingelheim Investigational Site
🇯🇵Bunkyo-ku, Tokyo, Japan
248.610.004 Boehringer Ingelheim Investigational Site
🇯🇵Sagamihara, Kanagawa, Japan
248.610.009 Boehringer Ingelheim Investigational Site
🇯🇵Shimogyo-ku, Kyoto, Kyoto, Japan
248.610.007 Boehringer Ingelheim Investigational Site
🇯🇵Shiroishi, Miyagi, Japan
248.610.003 Boehringer Ingelheim Investigational Site
🇯🇵Kodaira, Tokyo, Japan