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Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson Disease

Intervention: Pramipexole Extended Release (Drug); Pramipexole Immediate Release (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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.

Clinical Details

Official title: A Double-blind, Double-dummy, Randomized, Parallel Groups Study to Assess the Efficacy, Safety and Tolerability of Switching Patients With Early Parkinson's Disease (PD) From Pramipexole IR to Pramipexole ER or Pramipexole IR

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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)

Secondary outcome:

Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF)

Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF)

Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF)

Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF)

Clinical Global Impression - Improvement (CGI-I), FAS (LOCF)

Patient Global Impression - Improvement (PGI-I), FAS (LOCF)

Pramipexole Dose Adaptation, FAS (LOCF)

Final Pramipexole Dose (mg) After 9 Weeks, Treated Set

Eligibility

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Male or female patient with idiopathic Parkinson's disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity. 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: 1. Motor complications under levodopa therapy at V1. 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.

Locations and Contacts

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 cedex, 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 cedex, France

248.636.3304A Boehringer Ingelheim Investigational Site, Evreux, France

248.636.3308B Boehringer Ingelheim Investigational Site, Lille cedex, France

248.636.3308C Boehringer Ingelheim Investigational Site, Lille cedex, France

248.636.3308D Boehringer Ingelheim Investigational Site, Lille cedex, France

248.636.3308E Boehringer Ingelheim Investigational Site, Lille cedex, France

248.636.3302A Boehringer Ingelheim Investigational Site, Marseille cedex 5, France

248.636.3302B Boehringer Ingelheim Investigational Site, Marseille cedex 5, 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 cedex, France

248.636.3301B Boehringer Ingelheim Investigational Site, Toulouse cedex, France

248.636.3301D Boehringer Ingelheim Investigational Site, Toulouse cedex, France

248.636.49006 Boehringer Ingelheim Investigational Site, Achim bei Bremen, Germany

248.636.49003 Boehringer Ingelheim Investigational Site, Berlin-Steglitz, 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

248.636.49005 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

Additional Information

Starting date: October 2007
Last updated: May 7, 2014

Page last updated: August 23, 2015

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