Phase 3
Completed N=156
Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease
Source: ClinicalTrials.gov NCT00558025 ↗Enrolled (actual)
156
Serious AEs
0.0%
Results posted
Nov 2009
Primary outcomePrimary: Percentage of Patients Who Successfully Switched From Pramipexole Immediate Release (IR) to Pramipexole ER After a Possible Dose Adaptation, Full Analysis Set (FAS), Last Observation Carried Forward (LOCF) — 84.5; 94.2; 15.5; 5.8 Percentage of participants
Summary
The objectives of this trial conducted in early Parkinson's disease (PD) patients are:
* To assess if patients with early Parkinson's disease (PD) can be successfully switched (overnight switching) from Pramipexole (PPX) Immediate Release (IR) to Pramipexole Extended Release (ER). A successful switch at a specific visit is defined as no worsening of the Unified Parkinsons Disease Rating Scale (UPDRS) parts II+III score by more than 15% from baseline and no drug-related adverse events leading to withdrawal;
* To establish if this successful switch can be obtained with or without dose-adaptation;
* To provide information about the conversion ratio (mg:mg) from Pramipexole IR to Pramipexole ER.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Successfully Switched From Pramipexole Immediate Release (IR) to Pramipexole ER After a Possible Dose Adaptation, Full Analysis Set (FAS), Last Observation Carried Forward (LOCF) |
84.5; 94.2; 15.5; 5.8 | — |
| SECONDARY Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF) |
81.6; 92.3; 18.4; 7.7 | 0.0803 |
| SECONDARY Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF) |
-1.6; -0.5 | 0.2061 |
| SECONDARY Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF) |
-0.3; -0.1 | 0.4694 |
| SECONDARY Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF) |
-1.2; -0.3 | 0.1804 |
| SECONDARY Clinical Global Impression - Improvement (CGI-I), FAS (LOCF) |
90; 41; 13; 11 | 0.1623 |
| SECONDARY Patient Global Impression - Improvement (PGI-I), FAS (LOCF) |
84; 37; 19; 15 | 0.1299 |
| SECONDARY Pramipexole Dose Adaptation, FAS (LOCF) |
17; 7; 86; 45 | 0.6190 |
| SECONDARY Final Pramipexole Dose (mg) After 9 Weeks, Treated Set |
2.75; 2.83 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patient with idiopathic Parkinson's disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
- Parkinson's disease diagnosed within 5 years.
- Patients 30 years of age or older at the time of diagnosis.
- Modified Hoehn and Yahr stage of 1 to 3.
- Patients receiving pramipexole IR for at least three months prior to baseline visit (randomization visit, V2).
- Pramipexole dose should be optimized (according investigator¿s judgement), greater or equal to 1.5 mg/day, stable and equally divided 3 times per day, for a least 4 weeks prior to baseline visit (V2).
- Patients 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 Harmonization - Good Clinical Practice (ICH-GCP) guidelines and local legislation).
Exclusion Criteria
- Motor complications under levodopa therapy at V1.
- Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
- Dementia, as defined by a Mini-Mental State Exam score 2 Upper Limit of Normal (ULN) (on screening lab test).
- Patients with a creatinine clearance < 50 mL/min
- Any dopamine agonist (except pramipexole IR) within three months prior to baseline visit.
- History of discontinuation of treatment with pramipexole IR
- Previous treatment with pramipexole ER.
- Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit (i.e. typical neuroleptics, atypical antipsychotics, reserpine, methyldopa, centrally-active antiemetics, etc).
- Any of the following drugs within 4 weeks prior to the baseline visit: methylphenidate, cinnarizine, amphetamines.
- Flunarizine within 3 months prior to baseline visit.
- Known hypersensitivity to Pramipexole or its excipients.
- Drug abuse (including alcohol), according to Investigator¿s judgement, within 2 years prior to screening.
- Participation in other investigational drug studies or use of other investigational drugs within 4 weeks or five times the half-life of the investigational drug (whichever is longer) prior to baseline visit.
Data sourced from ClinicalTrials.gov (NCT00558025). 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.