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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
156
248.636.3303A Boehringer Ingelheim Investigational Site
Aix-en-Provence, France
248.636.3303B Boehringer Ingelheim Investigational Site
Aix-en-Provence, France
248.636.3303C Boehringer Ingelheim Investigational Site
Aix-en-Provence, France
248.636.3307C Boehringer Ingelheim Investigational Site
Bron, France
248.636.3309B Boehringer Ingelheim Investigational Site
Clermont-Ferrand, France
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)
A successful switch was defined by no change of the Unified Parkinson's Disease Rating Scale (UPDRS) II+III by more than 15% from baseline to week 9, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)
Time frame: from baseline to week 9
Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF)
A successful switch was defined by no change of the UPDRS II+III by more than 15% from baseline to week 4, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment).
Time frame: from baseline to week 4
Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF)
Unified Parkinson's Disease Rating Scale part II+III total score on FAS, Week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)
Time frame: Baseline and week 9
Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF)
Unified Parkinson's Disease Rating Scale part II total score on FAS, Week 9 - baseline, UPDRS II score ranging from 0 (no impairment) to 52 (worst impairment)
Time frame: Baseline and week 9
Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF)
Unified Parkinson's Disease Rating Scale part III total score on FAS, week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 108 (worst impairment)
Time frame: Baseline and week 9
Clinical Global Impression - Improvement (CGI-I), FAS (LOCF)
Clinical Global Impression - Improvement on FAS, CGI-I was rated from 1: very much improved, to 7: very much worse, CGI-I responder are defined as being rated as 'unchanged', 'minimally improved', 'much improved', or 'very much improved', CGI-I non-responder are defined as being rated 'minimally worse', 'much worse' or 'very much worse'
Time frame: Week 9
Patient Global Impression - Improvement (PGI-I), FAS (LOCF)
Patient Global Impression - Improvement on FAS, PGI-I was rated from 1: very much better, to 7: very much worse, PGI-I responder are defined as being rated as 'unchanged', 'minimally better', 'much better', or 'very much better', PGI-I non-responder are defined as being rated as 'minimally worse', 'much worse', or 'very much worse'
Time frame: Week 9
Pramipexole Dose Adaptation, FAS (LOCF)
Patients with increase in daily Pramipexole dose on FAS
Time frame: Week 9
Final Pramipexole Dose (mg) After 9 Weeks, Treated Set
The mean final daily Pramipexole dose is displayed
Time frame: Week 9
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
248.636.3305A Boehringer Ingelheim Investigational Site
Créteil, France
248.636.3305B Boehringer Ingelheim Investigational Site
Créteil, France
248.636.3313A Boehringer Ingelheim Investigational Site
Dijon, France
248.636.3304A Boehringer Ingelheim Investigational Site
Évreux, France
248.636.3308B Boehringer Ingelheim Investigational Site
Lille, France
...and 26 more locations