Clinical trial NCT00577460: Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD
Official title: Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Advanced Parkinson's Disease (PD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2007-12-20
Enrollment: 391
Sex: ALL
Minimum age (years): 32
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion criteria:

1. Completion of the double-blind trial 248.525
2. Male or female patient with advanced idiopathic Parkinson's disease (PD), with a Modified Hoehn and Yahr stage of 2 to 4 at on-time, and a concomitant treatment with standard or controlled release L-Dopa+, or a combination of L-Dopa+ and entacapone.
3. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular the patient should be able to recognise the off-time and on-time periods during waking hours and the patient (or a family member or a guardian) should be able to record them accurately in the patient diary.
4. Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference of Harmonization - Good Clinical Practice (ICH-GCP) guidelines and local legislation).

Exclusion criteria:

1. Patients prematurely withdrawn from the double-blind trial 248.525
2. Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases
3. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study
4. History of psychosis, except history of drug induced hallucinations
5. History of deep brain stimulation
6. Clinically significant ECG abnormalities at baseline
7. Clinically significant hypotension and/or symptomatic orthostatic hypotension at baseline
8. Malignant melanoma or history of previously treated malignant melanoma
9. Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study
10. Pregnancy or breast-feeding
11. Sexually active female of childbearing potential not using a medically approved method of birth control
12. Serum levels of aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase (SGOT)), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase) (SGPT)), alkaline phosphatase (AP) or bilirubin \> 2 upper limit normal (ULN) at baseline
13. Patients with a creatinine clearance \< 50 mL/min at baseline
14. Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
15. Any of the following drugs within 4 weeks prior to baseline visit: methylphenidate, cinnarizine, amphetamines
16. Flunarizine within 3 months prior to baseline
17. Known hypersensitivity to pramipexole or its excipients
18. Drug abuse, according to investigators judgement, within 2 years prior to baseline
19. Participation in investigational drug studies other than the trial 248.525, or use of other investigational drugs within one month or five times the half-life of the investigational drug (whichever is longer) prior to baseline

Primary outcomes:
measure: Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
timeFrame: 80 weeks
Secondary outcomes:
measure: Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III
timeFrame: One week
measure: UPDRS II+III Change From Open Label (OL) Baseline
timeFrame: OL Baseline and week 80
measure: Number of Participants With UPDRS II+III Response
timeFrame: Week 80
measure: Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time
timeFrame: One week
measure: Percentage Off Time During Waking Hours Total Score: Change From Baseline
timeFrame: Baseline and week 80
measure: Number of Participants With Response in Percentage Off Time During Waking Hours
timeFrame: 80 weeks
measure: Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
timeFrame: Baseline and week 80
measure: Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
timeFrame: Baseline and week 80
measure: Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
timeFrame: Baseline and week 80
measure: Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
timeFrame: Baseline and week 80
measure: Number of Participants With Response in CGI-I
timeFrame: 32 weeks
measure: Number of Participants With Response in PGI-I
timeFrame: 32 weeks
measure: Number of Participants With Response in PGI-I for Early Morning Off Symptoms
timeFrame: 32 weeks
measure: UPDRS I Total Score and Change From OL Baseline at Week 80
timeFrame: OL baseline and week 80
measure: UPDRS II Total Score and Change From OL Baseline at Week 80
timeFrame: OL baseline and week 80
measure: UPDRS III Total Score and Change From OL Baseline at Week 80
timeFrame: OL baseline and week 80
measure: UPDRS IV Total Score and Change From OL Baseline at Week 80
timeFrame: OL baseline and week 80
measure: Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80
timeFrame: OL baseline and week 80
measure: Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80
timeFrame: OL baseline and week 80
measure: Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline
timeFrame: OL baseline and week 80
measure: Number of Participants With Serious Adverse Events
timeFrame: 80 weeks
measure: Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
timeFrame: OL Baseline and Week 80
measure: Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
timeFrame: OL Baseline and Week 80
measure: Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
timeFrame: OL Baseline and Week 80
measure: Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
timeFrame: OL Baseline and Week 80
measure: Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set
timeFrame: OL Baseline and Week 80
measure: Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set
timeFrame: OL Baseline and Week 80
measure: Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set
timeFrame: OL Baseline and Week 80
measure: Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set
timeFrame: OL Baseline and Week 80
measure: Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set
timeFrame: OL Baseline and Week 80
measure: Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set
timeFrame: Baseline, 80 weeks
Other outcomes:
Locations:
city: Linz
country: Austria
facility: 248.634.43005 Boehringer Ingelheim Investigational Site
city: Pardubice
country: Czech Republic
facility: 248.634.42003 Boehringer Ingelheim Investigational Site
city: Praha
country: Czech Republic
facility: 248.634.42001 Boehringer Ingelheim Investigational Site
city: Rakovnik
country: Czech Republic
facility: 248.634.42005 Boehringer Ingelheim Investigational Site
city: Rychnov nad Kneznou
country: Czech Republic
facility: 248.634.42002 Boehringer Ingelheim Investigational Site
city: Valasske Mezirici
country: Czech Republic
facility: 248.634.42004 Boehringer Ingelheim Investigational Site
city: Györ
country: Hungary
facility: 248.634.36005 Boehringer Ingelheim Investigational Site
city: Kecskemét
country: Hungary
facility: 248.634.36003 Boehringer Ingelheim Investigational Site
city: Szeged
country: Hungary
facility: 248.634.36006 Boehringer Ingelheim Investigational Site
city: Veszprem
country: Hungary
facility: 248.634.36004 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 248.634.91002 Boehringer Ingelheim Investigational Site
city: Delhi
country: India
facility: 248.634.91001 Boehringer Ingelheim Investigational Site
city: Hyderabad
country: India
facility: 248.634.91003 Boehringer Ingelheim Investigational Site
city: Indore
country: India
facility: 248.634.91007 Boehringer Ingelheim Investigational Site
city: Karnataka
country: India
facility: 248.634.91005 Boehringer Ingelheim Investigational Site
city: Pune
country: India
facility: 248.634.91006 Boehringer Ingelheim Investigational Site
city: Catania
country: Italy
facility: 248.634.39001 Boehringer Ingelheim Investigational Site
city: Catanzaro
country: Italy
facility: 248.634.39010 Boehringer Ingelheim Investigational Site
city: Chieti
country: Italy
facility: 248.634.39009 Boehringer Ingelheim Investigational Site
city: Grosseto
country: Italy
facility: 248.634.39007 Boehringer Ingelheim Investigational Site
city: Napolii
country: Italy
facility: 248.634.39002 Boehringer Ingelheim Investigational Site
city: Pisa
country: Italy
facility: 248.634.39008 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 248.634.39005 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 248.634.39011 Boehringer Ingelheim Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: 248.634.82001 Boehringer Ingelheim Investigational Site
city: Kyeonggi-do
country: Korea, Republic of
facility: 248.634.82008 Boehringer Ingelheim Investigational Site
city: Pusan
country: Korea, Republic of
facility: 248.634.82007 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 248.634.82002 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 248.634.82003 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 248.634.82004 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 248.634.82005 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 248.634.82006 Boehringer Ingelheim Investigational Site
city: Cruz, Manila
country: Philippines
facility: 248.634.63202 Boehringer Ingelheim Investigational Site
city: Ermita, Manila
country: Philippines
facility: 248.634.63207 Boehringer Ingelheim Investigational Site
city: Makati City
country: Philippines
facility: 248.634.63210 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 248.634.63205 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 248.634.63206 Boehringer Ingelheim Investigational Site
city: Pasig City
country: Philippines
facility: 248.634.63201 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 248.634.63204 Boehringer Ingelheim Investigational Site
city: Quezon
country: Philippines
facility: 248.634.63208 Boehringer Ingelheim Investigational Site
city: Gdansk
country: Poland
facility: 248.634.48001 Boehringer Ingelheim Investigational Site
city: Krakow
country: Poland
facility: 248.634.48003 Boehringer Ingelheim Investigational Site
city: Warsaw
country: Poland
facility: 248.634.48002 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 248.634.07001 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 248.634.07002 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 248.634.07003 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 248.634.07004 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 248.634.07007 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 248.634.07006 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 248.634.42104 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 248.634.42105 Boehringer Ingelheim Investigational Site
city: Dubnica nad Vahom
country: Slovakia
facility: 248.634.42103 Boehringer Ingelheim Investigational Site
city: Trnava
country: Slovakia
facility: 248.634.42101 Boehringer Ingelheim Investigational Site
city: Alcorcon (Madrid)
country: Spain
facility: 248.634.34001 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 248.634.34003 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 248.634.34004 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 248.634.34005 Boehringer Ingelheim Investigational Site
city: San Cugat del Valles (Barcelona)
country: Spain
facility: 248.634.34002 Boehringer Ingelheim Investigational Site
city: Tarrasa (Barcelona)
country: Spain
facility: 248.634.34008 Boehringer Ingelheim Investigational Site
city: Malmö
country: Sweden
facility: 248.634.46005 Boehringer Ingelheim Investigational Site
city: Nyköping
country: Sweden
facility: 248.634.46002 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 248.634.46001 Boehringer Ingelheim Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: 248.634.38003 Boehringer Ingelheim Investigational Site
city: Kharkiv
country: Ukraine
facility: 248.634.38006 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 248.634.38002 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 248.634.38004 Boehringer Ingelheim Investigational Site
city: Zaporizhzhya
country: Ukraine
facility: 248.634.38005 Boehringer Ingelheim Investigational Site
city: Zaporozhye
country: Ukraine
facility: 248.634.38001 Boehringer Ingelheim Investigational Site
city: Blackburn
country: United Kingdom
facility: 248.634.44007 Boehringer Ingelheim Investigational Site
city: Salford
country: United Kingdom
facility: 248.634.44003 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: