Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease
NCT ID: NCT00558025
Last Updated: 2014-05-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
156 participants
INTERVENTIONAL
2007-10-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pramipexole Extended Release (ER)
Pramipexole Extended Release (ER) once daily
Pramipexole Extended Release
Pramipexole Immediate Release (IR)
Pramipexole Immediate Release (IR) once daily
Pramipexole Immediate Release
Interventions
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Pramipexole Extended Release
Pramipexole Immediate Release
Eligibility Criteria
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Inclusion Criteria
2. Parkinson's disease diagnosed within 5 years.
3. Patients 30 years of age or older at the time of diagnosis.
4. Modified Hoehn and Yahr stage of 1 to 3.
5. Patients receiving pramipexole IR for at least three months prior to baseline visit (randomization visit, V2).
6. 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).
7. Patients willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
8. 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
2. Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
3. Dementia, as defined by a Mini-Mental State Exam score \< 24 at V1
4. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
5. History of psychosis, except history of drug induced hallucinations
6. Clinically significant electrocardiogram (ECG) abnormalities at V1.
7. Clinically significant hypotension either at screening visit or at baseline visit.
8. Malignant melanoma or history of previously treated malignant melanoma.
9. Any other clinically significant disease
10. Pregnancy or breast-feeding.
11. Sexually active female of childbearing potential
12. 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).
13. Patients with a creatinine clearance \< 50 mL/min
14. Any dopamine agonist (except pramipexole IR) within three months prior to baseline visit.
15. History of discontinuation of treatment with pramipexole IR
16. Previous treatment with pramipexole ER.
17. 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).
18. Any of the following drugs within 4 weeks prior to the baseline visit: methylphenidate, cinnarizine, amphetamines.
19. Flunarizine within 3 months prior to baseline visit.
20. Known hypersensitivity to Pramipexole or its excipients.
21. Drug abuse (including alcohol), according to Investigator¿s judgement, within 2 years prior to screening.
22. 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.
30 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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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
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
248.636.3308C Boehringer Ingelheim Investigational Site
Lille, , France
248.636.3308D Boehringer Ingelheim Investigational Site
Lille, , France
248.636.3308E Boehringer Ingelheim Investigational Site
Lille, , France
248.636.3302A Boehringer Ingelheim Investigational Site
Marseille, , France
248.636.3302B Boehringer Ingelheim Investigational Site
Marseille, , France
248.636.3306B Boehringer Ingelheim Investigational Site
Montpellier, , France
248.636.3312A Boehringer Ingelheim Investigational Site
Rouen, , France
248.636.3312B Boehringer Ingelheim Investigational Site
Rouen, , France
248.636.3311A Boehringer Ingelheim Investigational Site
Strasbourg, , France
248.636.3301A Boehringer Ingelheim Investigational Site
Toulouse, , France
248.636.3301B Boehringer Ingelheim Investigational Site
Toulouse, , France
248.636.3301D Boehringer Ingelheim Investigational Site
Toulouse, , France
248.636.49006 Boehringer Ingelheim Investigational Site
Achim Bei Bremen, , Germany
248.636.49004 Boehringer Ingelheim Investigational Site
Berlin, , Germany
248.636.49007 Boehringer Ingelheim Investigational Site
Berlin, , Germany
248.636.49008 Boehringer Ingelheim Investigational Site
Berlin, , Germany
248.636.49002 Boehringer Ingelheim Investigational Site
Gera, , Germany
248.636.49001 Boehringer Ingelheim Investigational Site
Karlsruhe, , Germany
248.636.49003 Boehringer Ingelheim Investigational Site
Steglitz, , Germany
248.636.49005 Boehringer Ingelheim Investigational Site
Unterhaching, , Germany
248.636.31005 Boehringer Ingelheim Investigational Site
's-Hertogenbosch, , Netherlands
248.636.31002 Boehringer Ingelheim Investigational Site
Geldrop, , Netherlands
248.636.31003 Boehringer Ingelheim Investigational Site
Helmond, , Netherlands
248.636.31006 Boehringer Ingelheim Investigational Site
Maastricht, , Netherlands
248.636.31004 Boehringer Ingelheim Investigational Site
Nijmegen, , Netherlands
248.636.31001 Boehringer Ingelheim Investigational Site
Sittard, , Netherlands
Countries
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Other Identifiers
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Eudract 2007-003353-90
Identifier Type: -
Identifier Source: secondary_id
248.636
Identifier Type: -
Identifier Source: org_study_id
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