Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease
- Conditions
- Parkinson Disease
- Interventions
- Registration Number
- NCT00558025
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
- 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).
- 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 < 24 at V1
- Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
- History of psychosis, except history of drug induced hallucinations
- Clinically significant electrocardiogram (ECG) abnormalities at V1.
- Clinically significant hypotension either at screening visit or at baseline visit.
- Malignant melanoma or history of previously treated malignant melanoma.
- Any other clinically significant disease
- Pregnancy or breast-feeding.
- Sexually active female of childbearing potential
- Serum levels of Aspartate Aminotransferase (Serum Glutamic Oxaloacetic Transaminase) (AST (SGOT)), Alanine Aminotransferase (Serum Glutamate Pyruvate Transaminase) (ALT (SGPT)), alkaline phosphatases or bilirubin > 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pramipexole Extended Release (ER) Pramipexole Extended Release Pramipexole Extended Release (ER) once daily Pramipexole Immediate Release (IR) Pramipexole Immediate Release Pramipexole Immediate Release (IR) once daily
- Primary Outcome Measures
Name Time Method 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) from baseline to week 9 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)
- Secondary Outcome Measures
Name Time Method Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF) from baseline to week 4 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).
Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF) Baseline and week 9 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)
Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF) Baseline and week 9 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)
Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF) Baseline and week 9 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)
Clinical Global Impression - Improvement (CGI-I), FAS (LOCF) Week 9 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'
Patient Global Impression - Improvement (PGI-I), FAS (LOCF) Week 9 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'
Pramipexole Dose Adaptation, FAS (LOCF) Week 9 Patients with increase in daily Pramipexole dose on FAS
Final Pramipexole Dose (mg) After 9 Weeks, Treated Set Week 9 The mean final daily Pramipexole dose is displayed
Trial Locations
- Locations (36)
248.636.3307C Boehringer Ingelheim Investigational Site
🇫🇷Bron cedex, France
248.636.31005 Boehringer Ingelheim Investigational Site
🇳🇱's-hertogenbosch, Netherlands
248.636.3303B Boehringer Ingelheim Investigational Site
🇫🇷Aix en Provence, France
248.636.3308C Boehringer Ingelheim Investigational Site
🇫🇷Lille cedex, France
248.636.3302A Boehringer Ingelheim Investigational Site
🇫🇷Marseille cedex 5, France
248.636.31002 Boehringer Ingelheim Investigational Site
🇳🇱Geldrop, Netherlands
248.636.31006 Boehringer Ingelheim Investigational Site
🇳🇱Maastricht, Netherlands
248.636.3312A Boehringer Ingelheim Investigational Site
🇫🇷Rouen, France
248.636.3303A Boehringer Ingelheim Investigational Site
🇫🇷Aix en Provence, France
248.636.49003 Boehringer Ingelheim Investigational Site
🇩🇪Berlin-Steglitz, Germany
248.636.31003 Boehringer Ingelheim Investigational Site
🇳🇱Helmond, Netherlands
248.636.31004 Boehringer Ingelheim Investigational Site
🇳🇱Nijmegen, Netherlands
248.636.31001 Boehringer Ingelheim Investigational Site
🇳🇱Sittard, Netherlands
248.636.3303C Boehringer Ingelheim Investigational Site
🇫🇷Aix en Provence, France
248.636.3313A Boehringer Ingelheim Investigational Site
🇫🇷Dijon cedex, France
248.636.3309B Boehringer Ingelheim Investigational Site
🇫🇷Clermont Ferrand, France
248.636.3308B Boehringer Ingelheim Investigational Site
🇫🇷Lille cedex, France
248.636.3304A Boehringer Ingelheim Investigational Site
🇫🇷Evreux, France
248.636.3305B Boehringer Ingelheim Investigational Site
🇫🇷Créteil, France
248.636.3305A Boehringer Ingelheim Investigational Site
🇫🇷Créteil, France
248.636.3308D Boehringer Ingelheim Investigational Site
🇫🇷Lille cedex, France
248.636.3308E Boehringer Ingelheim Investigational Site
🇫🇷Lille cedex, France
248.636.3306B Boehringer Ingelheim Investigational Site
🇫🇷Montpellier, France
248.636.3311A Boehringer Ingelheim Investigational Site
🇫🇷Strasbourg, France
248.636.3312B Boehringer Ingelheim Investigational Site
🇫🇷Rouen, France
248.636.49006 Boehringer Ingelheim Investigational Site
🇩🇪Achim bei Bremen, Germany
248.636.3301A Boehringer Ingelheim Investigational Site
🇫🇷Toulouse cedex, France
248.636.3301D Boehringer Ingelheim Investigational Site
🇫🇷Toulouse cedex, France
248.636.3301B Boehringer Ingelheim Investigational Site
🇫🇷Toulouse cedex, France
248.636.49004 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
248.636.49002 Boehringer Ingelheim Investigational Site
🇩🇪Gera, Germany
248.636.49008 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
248.636.49001 Boehringer Ingelheim Investigational Site
🇩🇪Karlsruhe, Germany
248.636.49007 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
248.636.49005 Boehringer Ingelheim Investigational Site
🇩🇪Unterhaching, Germany
248.636.3302B Boehringer Ingelheim Investigational Site
🇫🇷Marseille cedex 5, France