Phase 3
Completed N=112
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
Source: ClinicalTrials.gov NCT00560508 ↗Enrolled (actual)
112
Serious AEs
19.6%
Results posted
Feb 2011
Primary outcomePrimary: Percentage of Participants Who Experienced Adverse Events — 83.93; 83.93 percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced Adverse Events |
83.93; 83.93 | — |
| SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score |
-13.6; -13.3 | — |
| SECONDARY Change From Baseline in Percentage Off-time |
-5.8; -7.8 | — |
| SECONDARY Change From Baseline in Percentage On-time Without Dyskinesia |
6.4; 7.0 | — |
| SECONDARY Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia |
-0.4; 0.1 | — |
| SECONDARY Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia |
6.0; 7.1 | — |
| SECONDARY Change From Baseline in Percentage On-time With Troublesome Dyskinesia |
-0.1; 0.5 | — |
| SECONDARY Responder Rate For Clinical Global Impression of Improvement (CGI-I) |
48.2; 50.0 | — |
| SECONDARY Responder Rate For Patient Global Impression of Improvement (PGI-I) |
33.9; 33.9 | — |
| SECONDARY Change From Baseline in UPDRS Part I Score |
0.1; -0.2 | — |
| SECONDARY Change From Baseline in UPDRS Part II Score |
-3.3; -3.4 | — |
| SECONDARY Change From Baseline in UPDRS Part III Score |
-10.2; -9.9 | — |
| SECONDARY Change From Baseline in UPDRS Part IV Score |
-0.2; -0.4 | — |
| SECONDARY UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) |
78.6; 82.1 | — |
| SECONDARY Change From Baseline in L-dopa Daily Dose |
-5.3; -1.8 | — |
| SECONDARY Trough Plasma Concentration at Steady State |
5.46; 5.09 | — |
| SECONDARY Dose Proportionality of Trough Plasma Concentration at Steady State After Pramipexole ER Treatment |
1.0375 | — |
| SECONDARY 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) |
-2.2; -0.2 | — |
| SECONDARY 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) |
78.4; 83.0 | — |
| SECONDARY 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) |
0.0; 1.9; 8.0; 5.7; 48.0; 35.8 | — |
| SECONDARY 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) |
2.0; 3.8; 14.0; 11.3; 36.0; 35.8 | — |
| SECONDARY Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Maintenance Phase) |
-15.2 | — |
| SECONDARY UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) (Open-label: Maintenance Phase) |
92.0 | — |
| SECONDARY Change From Baseline in Percentage Off-time (Open-label: Maintenance Phase) |
-11.6 | — |
| SECONDARY Change From Baseline in Percentage On-time Without Dyskinesia (Open-label: Maintenance Phase) |
11.9 | — |
| SECONDARY Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia (Open-label Maintenance Phase) |
-0.1 | — |
| SECONDARY Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia (Open-label Maintenance Phase) |
11.8 | — |
| SECONDARY Change From Baseline in Percentage On-time With Troublesome Dyskinesia (Open-label Maintenance Phase) |
-0.2 | — |
| SECONDARY Change From Baseline in L-dopa Daily Dose (Open-label Maintenance Phase) |
10.3 | — |
| SECONDARY Change From Baseline in UPDRS Part I Score (Open-label: Maintenance Phase) |
-0.3 | — |
| SECONDARY Change From Baseline in UPDRS Part II Score (Open-label: Maintenance Phase) |
-3.4 | — |
| SECONDARY Change From Baseline in UPDRS Part III Score (Open-label: Maintenance Phase) |
-11.9 | — |
| SECONDARY Change From Baseline in UPDRS Part IV Score (Open-label: Maintenance Phase) |
-0.6 | — |
Eligibility Criteria
Inclusion criteria
- Male or female patients with diagnosis of PD including juvenile Parkinsonism, in whom the onset began at the age of forty or younger.
- Patients with a modified Hoehn and Yahr scale of II to IV at "on" time.
- Patients who have received an individual dosage of L-DOPA (either standard L-DOPA or L-DOPA with dopa-decarboxylase inhibitor) at a stable dose for at least 4 weeks before the baseline visit (Visit 2).
- Patients who exhibit any therapeutically problematic issues or status based on L-DOPA therapy:
- wearing-off phenomena
- no on /delayed on
- dystonia at off time
- on-off phenomena
- freezing phenomena at off time
- the sub-optimal dose of L-DOPA had been administered due to side effects (such as dyskinesia), or therapeutical strategy
Exclusion criteria
- Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
- Dementia, as defined by a Mini-Mental State Examination (MMSE) score =20 mmHg in systolic blood pressure and a decline >=10 mmHg in diastolic blood pressure, at one minute after standing compared with the previous supine systolic and diastolic blood pressure obtained after 5 minutes of quiet rest) either at screening visit or at baseline visit.
- Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the trial.
- Pregnancy (to be excluded by serum pregnancy test at screening visit) or breast-feeding.
- Sexually active female of childbearing potential not using a medically approved method of birth control within one month before to the screening visit and throughout the trial period.
- Serum levels of AST, ALT, alkaline phosphatases or bilirubin >2 upper limits of normal .
- Patients with a creatinine clearance <50 mL/min
- Patients with a complication or signs of malignant tumours or those within 5 years after the treatment.
Data sourced from ClinicalTrials.gov (NCT00560508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.