Phase 3
Completed N=511
Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).
Source: ClinicalTrials.gov NCT00601523 ↗Enrolled (actual)
511
Serious AEs
14.5%
Results posted
Aug 2011
Primary outcomePrimary: Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events — 84.5; 76.2; 45.7; 23.1 Percentage of participants
Summary
The general aim of this study is to obtain long-term safety and tolerability data on pramipexole ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or 248.636(NCT00558025) trial).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events |
84.5; 76.2; 45.7; 23.1; 14.4; 14.7 | — |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline |
2.2; 1.5 | — |
| SECONDARY Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636) |
73; 27 | — |
| SECONDARY UPDRS I Total Score: Change From OL Baseline |
0.3; 0.1 | — |
| SECONDARY UPDRS II Total Score: Change From OL Baseline |
1.0; 0.6 | — |
| SECONDARY UPDRS III Total Score: Change From OL Baseline |
1.1; 0.9 | — |
| SECONDARY Response in Clinical Global Impression of Improvement (CGI-I) |
284; 108 | — |
| SECONDARY Response in Patient Global Impression of Improvement (PGI-I) |
265; 111 | — |
| SECONDARY Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline |
2.0; 2.2 | — |
| SECONDARY Number of Patients Introducing L-Dopa Medication in OL Trial |
320; 117; 47; 21 | — |
| SECONDARY L-Dopa Dose: Change From OL Baseline |
4; 0; 9; 23; 19; 41 | — |
| SECONDARY Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients |
101; 9; 82; 44; 156; 73 | — |
| SECONDARY Patient Preference Regarding Treatment Dosing |
275; 78; 9; 1; 7; 4 | — |
| SECONDARY Patient Rating of Convenience of Treatment Dosing |
196; 59; 79; 19; 2; 0 | — |
Eligibility Criteria
Inclusion criteria
- Completion of the double-blind trial 248.524 or 248.636
- Male or female patient with early idiopathic Parkinson´s disease (PD), and with a Modified Hoehn and Yahr stage of I to III.
- Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) guidelines and local legislation).
Exclusion criteria
- Patients prematurely withdrawn from the double-blind trials 248.524 or 248.636.
- Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
- Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study.4.History of psychosis, except history of drug induced hallucinations.
- Clinically significant electrocardiogram (ECG) abnormalities at baseline. 6.Clinically significant hypotension 7.Malignant melanoma or history of previously treated malignant melanoma. 8.Any other clinically significant disease, that could put the patient at risk or could prevent compliance or completion of the study. 9. Pregnancy or breast-feeding.
- Sexually active female of childbearing potential not using a medically approved method of birth control for at least one month prior to the baseline and throughout the study.11 Serum levels of aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), alkaline phosphatase or bilirubin > 2 upper limit of normal (ULN) at baseline 12. Patients with a creatinine clearance < 50 mL/min (estimated by the Cockcroft and Gault formula). 13. Motor complications under levodopa therapy (e.g. on-off phenomena, dyskinesia) at baseline.
- Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit. 15.Any of the following drugs within 4 weeks prior to baseline: methylphenidate, cinnarizine, amphetamines. 16. Flunarizine within 3 months prior to baseline.
- Known hypersensitivity to pramipexole or its excipients. 18. Drug abuse (including alcohol), according to investigator´s judgement, within 2 years prior to baseline.
- Participation in investigational drug studies other than trials 248.524 and 248.636 or use of other investigational drug within one month or five times the half-life of the investigational drug prior to baseline.
Data sourced from ClinicalTrials.gov (NCT00601523). 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.