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

Boehringer Ingelheim119 sites in 5 countries511 target enrollmentJanuary 2008

ConditionsParkinson Disease

InterventionsPramipexole Placebo

DrugsPlacebo Pramipexole

Overview

Phase: Phase 3
Intervention: Pramipexole
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Enrollment: 511
Locations: 119
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 ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or 248.636(NCT00558025) trial).

Registry

clinicaltrials.gov

Start Date

January 2008

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

Patient to receive Pramipexole ER 0.375-4.5 mg tabl form daily

Intervention: Pramipexole

Placebo

Patient 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 (patients from 248.524) or 72 weeks (patients from 248.636)

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 early PD (248.524 (NCT00479401) or 248.636 (NCT00558025)). Therefore these items were considered as a safety evaluation

Secondary Outcomes

Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline(Open Label (OL) baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636))
Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636)(OL Baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636))
UPDRS I Total Score: Change From OL Baseline(OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636))
UPDRS II Total Score: Change From OL Baseline(OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636))
UPDRS III Total Score: Change From OL Baseline(OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636))
Response in Clinical Global Impression of Improvement (CGI-I)(OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636))
Response in Patient Global Impression of Improvement (PGI-I)(OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636))
Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline(OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636))
Number of Patients Introducing L-Dopa Medication in OL Trial(80 weeks (patients from 248.524) or 72 weeks (patients from 248.636))
L-Dopa Dose: Change From OL Baseline(OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636))
Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients(Week 8 and week 80 (patients from 248.524) or week 0 and week 72 (patients from 248.636))
Patient Preference Regarding Treatment Dosing(80 weeks (patients from 248.524) or 72 weeks (patients from 248.636))
Patient Rating of Convenience of Treatment Dosing(80 weeks (patients from 248.524) or 72 weeks (patients from 248.636))