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

Boehringer Ingelheim36 sites in 3 countries156 target enrollmentOctober 2007

ConditionsParkinson Disease

InterventionsPramipexole Immediate Release Pramipexole Extended Release

DrugsPramipexole Extended Release Pramipexole Immediate Release

Overview

Phase: Phase 3
Intervention: Pramipexole Immediate Release
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Enrollment: 156
Locations: 36
Primary Endpoint: 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)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

May 2008

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

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
•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 V
•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 V
•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.

Arms & Interventions

Pramipexole Immediate Release (IR)

Pramipexole Immediate Release (IR) once daily

Intervention: Pramipexole Immediate Release

Pramipexole Extended Release (ER)

Pramipexole Extended Release (ER) once daily

Intervention: Pramipexole Extended Release

Outcomes

Primary Outcomes

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)

Time Frame: 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 Outcomes

Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF)(from baseline to week 4)
Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF)(Baseline and week 9)
Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF)(Baseline and week 9)
Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF)(Baseline and week 9)
Clinical Global Impression - Improvement (CGI-I), FAS (LOCF)(Week 9)
Patient Global Impression - Improvement (PGI-I), FAS (LOCF)(Week 9)
Pramipexole Dose Adaptation, FAS (LOCF)(Week 9)
Final Pramipexole Dose (mg) After 9 Weeks, Treated Set(Week 9)