Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Advanced Parkinson's Disease (PD)

Boehringer Ingelheim70 sites in 10 countries391 target enrollmentDecember 2007

ConditionsParkinson Disease

InterventionsPramipexole Placebo

DrugsPramipexole Placebo

Overview

Phase: Phase 3
Intervention: Pramipexole
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Enrollment: 391
Locations: 70
Primary Endpoint: Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The general aim of this study is to obtain long-term safety and tolerability data on pramipexole extended release (ER), in daily doses from 0.375mg to 4.5mg once daily (qd), in patients who have previously completed a pramipexole double-blind study in advanced Parkinson's disease (PD) (248.525 trial).

Registry

clinicaltrials.gov

Start Date

December 2007

End Date

June 2010

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Pramipexole

Patients to receive Pramipexole ER 0.375 - 4.5 mg in tablet form daily

Intervention: Pramipexole

Placebo

Patients to receive placebo tablets identical to Pramipexole ER tablets only during transfer phase

Intervention: Placebo

Outcomes

Primary Outcomes

Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events

Time Frame: 80 weeks

The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation.

Secondary Outcomes

Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III(One week)
UPDRS II+III Change From Open Label (OL) Baseline(OL Baseline and week 80)
Number of Participants With UPDRS II+III Response(Week 80)
Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time(One week)
Percentage Off Time During Waking Hours Total Score: Change From Baseline(Baseline and week 80)
Number of Participants With Response in Percentage Off Time During Waking Hours(80 weeks)
Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks(Baseline and week 80)
Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks(Baseline and week 80)
Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks(Baseline and week 80)
Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks(Baseline and week 80)
Number of Participants With Response in CGI-I(32 weeks)
Number of Participants With Response in PGI-I(32 weeks)
Number of Participants With Response in PGI-I for Early Morning Off Symptoms(32 weeks)
UPDRS I Total Score and Change From OL Baseline at Week 80(OL baseline and week 80)
UPDRS II Total Score and Change From OL Baseline at Week 80(OL baseline and week 80)
UPDRS III Total Score and Change From OL Baseline at Week 80(OL baseline and week 80)
UPDRS IV Total Score and Change From OL Baseline at Week 80(OL baseline and week 80)
Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80(OL baseline and week 80)
Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80(OL baseline and week 80)
Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline(OL baseline and week 80)
Number of Participants With Serious Adverse Events(80 weeks)
Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set(OL Baseline and Week 80)
Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set(OL Baseline and Week 80)
Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set(OL Baseline and Week 80)
Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set(OL Baseline and Week 80)
Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set(OL Baseline and Week 80)
Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set(OL Baseline and Week 80)
Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set(OL Baseline and Week 80)
Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set(OL Baseline and Week 80)
Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set(OL Baseline and Week 80)
Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set(Baseline, 80 weeks)