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

NCT ID: NCT00577460

Last Updated: 2014-05-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

391 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pramipexole

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

Group Type ACTIVE_COMPARATOR

Pramipexole

Intervention Type DRUG

Pramipexole ER 0.375 -4.5 mg

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets identical to Pramipexole ER tablets

Interventions

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Pramipexole

Pramipexole ER 0.375 -4.5 mg

Intervention Type DRUG

Placebo

Placebo tablets identical to Pramipexole ER tablets

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

32 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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248.634.43005 Boehringer Ingelheim Investigational Site

Linz, , Austria

Site Status

248.634.42003 Boehringer Ingelheim Investigational Site

Pardubice, , Czechia

Site Status

248.634.42001 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

248.634.42005 Boehringer Ingelheim Investigational Site

Rakovník, , Czechia

Site Status

248.634.42002 Boehringer Ingelheim Investigational Site

Rychnov nad Kněžnou, , Czechia

Site Status

248.634.42004 Boehringer Ingelheim Investigational Site

Valašské Meziříčí, , Czechia

Site Status

248.634.36005 Boehringer Ingelheim Investigational Site

Győr, , Hungary

Site Status

248.634.36003 Boehringer Ingelheim Investigational Site

Kecskemét, , Hungary

Site Status

248.634.36006 Boehringer Ingelheim Investigational Site

Szeged, , Hungary

Site Status

248.634.36004 Boehringer Ingelheim Investigational Site

Veszprém, , Hungary

Site Status

248.634.91002 Boehringer Ingelheim Investigational Site

Chennai, , India

Site Status

248.634.91001 Boehringer Ingelheim Investigational Site

Delhi, , India

Site Status

248.634.91003 Boehringer Ingelheim Investigational Site

Hyderabad, , India

Site Status

248.634.91007 Boehringer Ingelheim Investigational Site

Indore, , India

Site Status

248.634.91005 Boehringer Ingelheim Investigational Site

Karnataka, , India

Site Status

248.634.91006 Boehringer Ingelheim Investigational Site

Pune, , India

Site Status

248.634.39001 Boehringer Ingelheim Investigational Site

Catania, , Italy

Site Status

248.634.39010 Boehringer Ingelheim Investigational Site

Catanzaro, , Italy

Site Status

248.634.39009 Boehringer Ingelheim Investigational Site

Chieti, , Italy

Site Status

248.634.39007 Boehringer Ingelheim Investigational Site

Grosseto, , Italy

Site Status

248.634.39002 Boehringer Ingelheim Investigational Site

Napolii, , Italy

Site Status

248.634.39008 Boehringer Ingelheim Investigational Site

Pisa, , Italy

Site Status

248.634.39005 Boehringer Ingelheim Investigational Site

Roma, , Italy

Site Status

248.634.39011 Boehringer Ingelheim Investigational Site

Roma, , Italy

Site Status

248.634.63202 Boehringer Ingelheim Investigational Site

Cruz, Manila, , Philippines

Site Status

248.634.63207 Boehringer Ingelheim Investigational Site

Ermita, Manila, , Philippines

Site Status

248.634.63210 Boehringer Ingelheim Investigational Site

Makati City, , Philippines

Site Status

248.634.63205 Boehringer Ingelheim Investigational Site

Manila, , Philippines

Site Status

248.634.63206 Boehringer Ingelheim Investigational Site

Manila, , Philippines

Site Status

248.634.63201 Boehringer Ingelheim Investigational Site

Pasig, , Philippines

Site Status

248.634.63208 Boehringer Ingelheim Investigational Site

Quezon, , Philippines

Site Status

248.634.63204 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

Site Status

248.634.48001 Boehringer Ingelheim Investigational Site

Gdansk, , Poland

Site Status

248.634.48003 Boehringer Ingelheim Investigational Site

Krakow, , Poland

Site Status

248.634.48002 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

Site Status

248.634.07001 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

248.634.07002 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

248.634.07003 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

248.634.07004 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

248.634.07007 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

248.634.07006 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

248.634.42104 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

Site Status

248.634.42105 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

Site Status

248.634.42103 Boehringer Ingelheim Investigational Site

Dubnica nad Váhom, , Slovakia

Site Status

248.634.42101 Boehringer Ingelheim Investigational Site

Trnava, , Slovakia

Site Status

248.634.82001 Boehringer Ingelheim Investigational Site

Gyeonggi-do, , South Korea

Site Status

248.634.82008 Boehringer Ingelheim Investigational Site

Kyeonggi-do, , South Korea

Site Status

248.634.82007 Boehringer Ingelheim Investigational Site

Pusan, , South Korea

Site Status

248.634.82002 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

248.634.82003 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

248.634.82004 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

248.634.82005 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

248.634.82006 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

248.634.34001 Boehringer Ingelheim Investigational Site

Alcorcon (Madrid), , Spain

Site Status

248.634.34003 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

248.634.34004 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

248.634.34005 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

248.634.34002 Boehringer Ingelheim Investigational Site

San Cugat Del Valles (Barcelona), , Spain

Site Status

248.634.34008 Boehringer Ingelheim Investigational Site

Tarrasa (Barcelona), , Spain

Site Status

248.634.46005 Boehringer Ingelheim Investigational Site

Malmo, , Sweden

Site Status

248.634.46002 Boehringer Ingelheim Investigational Site

Nyköping, , Sweden

Site Status

248.634.46001 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

248.634.38003 Boehringer Ingelheim Investigational Site

Dnipropetrovsk, , Ukraine

Site Status

248.634.38006 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

248.634.38002 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

248.634.38004 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

248.634.38001 Boehringer Ingelheim Investigational Site

Zaporizhzhya, , Ukraine

Site Status

248.634.38005 Boehringer Ingelheim Investigational Site

Zaporizhzhya, , Ukraine

Site Status

248.634.44007 Boehringer Ingelheim Investigational Site

Blackburn, , United Kingdom

Site Status

248.634.44003 Boehringer Ingelheim Investigational Site

Salford, , United Kingdom

Site Status

Countries

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Austria Czechia Hungary India Italy Philippines Poland Russia Slovakia South Korea Spain Sweden Ukraine United Kingdom

Other Identifiers

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2007-004235-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

248.634

Identifier Type: -

Identifier Source: org_study_id

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