Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD

Phase 3

Completed

Conditions: Parkinson Disease

Interventions: Drug: Placebo
Drug: Pramipexole

Registration Number: NCT00577460

Lead Sponsor: Boehringer Ingelheim

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 391

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients to receive placebo tablets identical to Pramipexole ER tablets only during transfer phase
Pramipexole	Pramipexole	Patients to receive Pramipexole ER 0.375 - 4.5 mg in tablet form daily

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events	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 Outcome Measures

Name	Time	Method
Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III	One week	Unified Parkinson's Disease Rating Scale (UPDRS) Successfully switched means: UPDRS II+III baseline score \>20 without a relative worsening of UPDRS II+III score \> 15% from baseline or UPDRS II+III baseline score \<=20 without an absolute worsening of UPDRS II+III score \> 3 from baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
UPDRS II+III Change From Open Label (OL) Baseline	OL Baseline and week 80	UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Number of Participants With UPDRS II+III Response	Week 80	A response means an improvement of \>=20% in UPDRS II+III from OL baseline UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time	One week	A patient was considered as successfully switched if he/she has converted to ER without a worsening of off time by more than 12.5% from baseline. Off-time is based on patient diary data and describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).
Percentage Off Time During Waking Hours Total Score: Change From Baseline	Baseline and week 80	Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). A negative change implies improvement
Number of Participants With Response in Percentage Off Time During Waking Hours	80 weeks	Response means \>=20% improvement relative to OL baseline in the % off-time during waking hours
Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks	Baseline and week 80	Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement.
Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks	Baseline and week 80	Percentage on-time with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement
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 without dyskinesia or with non troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement
Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks	Baseline and week 80	Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep. A positive change implies improvement
Number of Participants With Response in CGI-I	32 weeks	Clinical Global Impression of Improvement (CGI-I), CGI-I scores ranging from '1' (very much improved) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much improved" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much improved were considered as responders
Number of Participants With Response in PGI-I	32 weeks	Patient Global Impression of Improvement (PGI-I), PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders
Number of Participants With Response in PGI-I for Early Morning Off Symptoms	32 weeks	Patient Global Impression of Improvement (PGI-I) for early morning off symptoms, PGI-I scores ranging from '1' (very much better) to '7' (very much worse). For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with PPX ER or IR, all patients with no change to very much better were considered as responders
UPDRS I Total Score and Change From OL Baseline at Week 80	OL baseline and week 80	UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood
UPDRS II Total Score and Change From OL Baseline at Week 80	OL baseline and week 80	UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities
UPDRS III Total Score and Change From OL Baseline at Week 80	OL baseline and week 80	UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms
UPDRS IV Total Score and Change From OL Baseline at Week 80	OL baseline and week 80	UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy
Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80	OL baseline and week 80	PFS-16 (Parkinson fatigue scale) ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD
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	ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)
Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set	Baseline, 80 weeks	The mMIDI is a semi-structured interview designed to assess impulsive control disorders. The scale was modified to focus behaviors of: pathological gambling, compulsive buying and compulsive sexual behavioral.

Trial Locations

Locations (70): 248.634.43005 Boehringer Ingelheim Investigational Site
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Linz, Austria
248.634.42003 Boehringer Ingelheim Investigational Site
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Pardubice, Czech Republic
248.634.42001 Boehringer Ingelheim Investigational Site
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Praha, Czech Republic
248.634.42005 Boehringer Ingelheim Investigational Site
🇨🇿
Rakovnik, Czech Republic
248.634.42002 Boehringer Ingelheim Investigational Site
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Rychnov nad Kneznou, Czech Republic
248.634.42004 Boehringer Ingelheim Investigational Site
🇨🇿
Valasske Mezirici, Czech Republic
248.634.36005 Boehringer Ingelheim Investigational Site
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Györ, Hungary
248.634.36003 Boehringer Ingelheim Investigational Site
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Kecskemét, Hungary
248.634.36006 Boehringer Ingelheim Investigational Site
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Szeged, Hungary
248.634.36004 Boehringer Ingelheim Investigational Site
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Veszprem, Hungary
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248.634.43005 Boehringer Ingelheim Investigational Site
🇦🇹Linz, Austria