A Double-blind, Double-dummy, Randomised, Parallel-group Study to Investigate the Safety, Tolerability, Trough Plasma Concentration, and Efficacy of Pramipexole ER Versus Pramipexole Immediate Release (IR) Administered Orally for 12 Weeks in Patients With Parkinson's Disease (PD) on L-dopa Therapy, Followed by a 52-week Open-label Long-term Treatment Period to Evaluate the Long-term Safety and Efficacy of Pramipexole ER

Boehringer Ingelheim19 sites in 1 country112 target enrollmentNovember 2007

ConditionsParkinson Disease

InterventionsPramipexole Extended Release Pramipexole Immediate Release

Overview

Phase: Phase 2
Intervention: Pramipexole Extended Release
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Enrollment: 112
Locations: 19
Primary Endpoint: Percentage of Participants Who Experienced Adverse Events
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this trial is to investigate the safety, tolerability, trough plasma concentration, and efficacy of pramipexole ER in comparison with those of pramipexole IR administrated orally for 12 weeks in patients with PD on levodopa (L-DOPA) therapy (the double-blind period). The double-blind period will be followed by the open-label 52 week administration of pramipexole ER to evaluate the long term safety and efficacy (the open-label period).

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

November 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Pramipexole Extended Release

patient to receive a tablet containing 0.375 mg Pramipexole ER once a day plus containing 0.125 mg Pramipexole IR placebo twice a day -\> a tablet containing 1.5 mg Pramipexole ER three times daily (TID) plus 0.5 mg Pramipexole IR placebo TID

Intervention: Pramipexole Extended Release

Pramipexole Immediate Release

patient to receive a tablet containing 0.125 mg Pramipexole IR twice a day plus containing 0.375 mg Pramipexole ER placebo once a day -\> a tablet containing 0.5 mg Pramipexole IR three times daily (TID) plus 1.5 mg Pramipexole ER placebo TID

Intervention: Pramipexole Immediate Release

Outcomes

Primary Outcomes

Percentage of Participants Who Experienced Adverse Events

Time Frame: 12 weeks

An adverse event is defined as any untoward medical occurrence

Secondary Outcomes

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score(baseline and after 12 weeks treatment)
Change From Baseline in Percentage Off-time(baseline and after 12 weeks treatment)
Change From Baseline in Percentage On-time Without Dyskinesia(baseline and after 12 weeks treatment)
Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia(baseline and after 12 weeks treatment)
Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia(baseline and after 12 weeks treatment)
Change From Baseline in UPDRS Part II Score(baseline and after 12 weeks treatment)
Change From Baseline in UPDRS Part III Score(baseline and after 12 weeks treatment)
Change From Baseline in UPDRS Part IV Score(baseline and after 12 weeks treatment)
UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement)(baseline and after 12 weeks treatment)
Change From Baseline in L-dopa Daily Dose(baseline and after 12 weeks treatment)
Trough Plasma Concentration at Steady State(at Visit 8 after pramipexole ER 4.5mg and IR 4.5mg treatment)
Change From Baseline in Percentage On-time With Troublesome Dyskinesia(baseline and after 12 weeks treatment)
Responder Rate For Clinical Global Impression of Improvement (CGI-I)(baseline and after 12 weeks treatment)
Responder Rate For Patient Global Impression of Improvement (PGI-I)(baseline and after 12 weeks treatment)
Change From Baseline in UPDRS Part I Score(baseline and after 12 weeks treatment)
Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)(Week 12 to Week 16)
Dose Proportionality of Trough Plasma Concentration at Steady State After Pramipexole ER Treatment(from Visit 1 to Visit 8 after pramipexole ER)
Change From End of Double-Blind Period in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Dose Adjustment Phase)(Week 12 to Week 16)
Percentage of Patients With no Worsening of UPDRS Parts II+III Total Score by More Than 15% From Week 12 to Week 16 (Open-label: Dose Adjustment Phase)(Week 12 to Week 16)
UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) (Open-label: Maintenance Phase)(baseline and after 64 weeks treatment)
Change From Baseline in Percentage Off-time (Open-label: Maintenance Phase)(baseline and after 64 weeks treatment)
Change From Baseline in Percentage On-time Without Dyskinesia (Open-label: Maintenance Phase)(baseline and after 64 weeks treatment)
Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia (Open-label Maintenance Phase)(baseline and after 64 weeks treatment)
Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)(Week 12 to Week 16)
Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Maintenance Phase)(Baseline and after 64 weeks treatment)
Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia (Open-label Maintenance Phase)(baseline and after 64 weeks treatment)
Change From Baseline in Percentage On-time With Troublesome Dyskinesia (Open-label Maintenance Phase)(baseline and after 64 weeks treatment)
Change From Baseline in L-dopa Daily Dose (Open-label Maintenance Phase)(baseline and after 64 weeks treatment)
Change From Baseline in UPDRS Part I Score (Open-label: Maintenance Phase)(baseline and after 64 weeks treatment)
Change From Baseline in UPDRS Part II Score (Open-label: Maintenance Phase)(baseline and after 64 weeks treatment)
Change From Baseline in UPDRS Part III Score (Open-label: Maintenance Phase)(baseline and after 64 weeks treatment)
Change From Baseline in UPDRS Part IV Score (Open-label: Maintenance Phase)(baseline and after 64 weeks treatment)