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Pivotal Study in Advanced Parkinsons Disease Patients

NCT ID: NCT00466167

Last Updated: 2014-07-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

517 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Brief Summary

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The general aim of this trial is to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for Unified Parkinsons Disease Rating Scale Parts II and III combined), safety, and tolerability of pramipexole ER, in daily doses from 0.375 milligram to 4.5 milligram once a day, in comparison to placebo, in Levodopa combined with a Dopa-Decarboxylase-inhibitor treated Parkinson patients with advanced Parkinsons Disease and motor fluctuations.

In addition, a numerical comparison of the efficacy of pramipexole extended release versus pramipexole immediate release will be done.

The efficacy of pramipexole immediate release will also be compared to placebo, for assay sensitivity.

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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Pramipexole ER

Group Type OTHER

Pramipexol Extended Release

Intervention Type DRUG

Pramipexole IR

Group Type OTHER

Pramipexol Immediate Release

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Pramipexol Extended Release

Intervention Type DRUG

Pramipexol Immediate Release

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female patient with advanced idiopathic Parkinsons disease confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
2. Parkinsons disease diagnosed for at least 2 years.
3. Patients 30 years of age or older at the time of diagnosis.
4. Modified Hoehn and Yahr stage of 2 to 4 at on-time.
5. Treatment with standard or controlled release Levodopa combined with a Dopa-Decarboxylase-inhibitor, or with Levodopa combined with a Dopa-Decarboxylase-inhibitor/entacapone, at an optimised dose according to investigators judgement, this dose being stable for at least 4 weeks prior to baseline visit.
6. Motor fluctuations, with at least 2 cumulative hours of off-time every day during waking hours (documented on a patient diary completed for 2 consecutive days before baseline visit).
7. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular, after training, it has to be documented at baseline visit that the patient is able to recognise the off-time and on-time periods during waking hours and that the patient (or a family member or a guardian) is able to record them accurately in the patient diary.
8. Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference on Harmonisation-Good Clinical Practice guidelines and local legislation).

Exclusion Criteria

1. Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases
2. Dementia, as defined by a Mini-Mental State Exam score \< 24 at screening visit
3. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders 4th edition 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 Electrocardiogram abnormalities at screening visit
7. Clinically significant hypotension and/or symptomatic orthostatic hypotension at screening or baseline visit
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 for at least one month prior to the screening visit and throughout the study period
12. Serum levels of Aspartate Aminotransferase (Serum Glutamic-Oxaloacetic Transaminase), Alanine Aminotransferase (Serum Glutamic Pyruvic Transaminase), alkaline phosphatases or bilirubin \> 2 Upper Limit of Normal
13. Patients with a creatinine clearance \< 50 millilitres/minute
14. Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit
15. Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
16. Any of the following drugs within 4 weeks prior to baseline visit: methylphenidate, cinnarizine, amphetamines
17. Flunarizine within 3 months prior to baseline visit
18. Known hypersensitivity to pramipexole or its excipients
19. Drug abuse according to investigators judgement, within 2 years prior to screening
20. Participation in other investigational drug studies, 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 visit
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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248.525.39005 Università La Sapienza di Roma

Roma, , Italy

Site Status

248.525.39011 Policlinico Tor Vergata

Roma, , Italy

Site Status

248.525.63210 Makati Medical Center

Makati City, , Philippines

Site Status

248.525.63202 Chinese General Hospital

Manila, , Philippines

Site Status

248.525.63205 Jose Reyes Memorial Medical Center

Manila, , Philippines

Site Status

248.525.63206 Metropolitan Medical Center

Manila, , Philippines

Site Status

248.525.63207 Manila Doctors Hospital

Manila, , Philippines

Site Status

248.525.63201 The Medical City

Pasig, , Philippines

Site Status

248.525.63204 St Lukes Medical Center

Quezon, , Philippines

Site Status

248.525.63208 University of the East Ramon Magsaysay Memorial Medical Ctr

Quezon, , Philippines

Site Status

248.525.48001 Boehringer Ingelheim Investigational Site

Gdansk, , Poland

Site Status

248.525.48003 Boehringer Ingelheim Investigational Site

Krakow, , Poland

Site Status

248.525.48002 Wolski Hospital Dr. Anna Gostynska

Warsaw, , Poland

Site Status

248.525.07001 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

248.525.07002 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

248.525.07003 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

248.525.07004 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

248.525.07007 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

248.525.07005 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

248.525.07006 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

248.525.42104 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

Site Status

248.525.42105 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

Site Status

248.525.42103 Boehringer Ingelheim Investigational Site

Dubnica nad Váhom, , Slovakia

Site Status

248.525.42101 Boehringer Ingelheim Investigational Site

Trnava, , Slovakia

Site Status

248.525.82001 Boehringer Ingelheim Investigational Site

Gyeonggi-do, , South Korea

Site Status

248.525.82008 Boehringer Ingelheim Investigational Site

Kyeonggi-do, , South Korea

Site Status

248.525.82007 Boehringer Ingelheim Investigational Site

Pusan, , South Korea

Site Status

248.525.82002 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

248.525.82003 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

248.525.82004 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

248.525.82005 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

248.525.82006 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

248.525.34001 Boehringer Ingelheim Investigational Site

Alcorcon (Madrid), , Spain

Site Status

248.525.34003 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

248.525.34004 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

248.525.34005 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

248.525.34002 Boehringer Ingelheim Investigational Site

San Cugat Del Valles (Barcelona), , Spain

Site Status

248.525.34008 Boehringer Ingelheim Investigational Site

Tarrasa (Barcelona), , Spain

Site Status

248.525.46005 Boehringer Ingelheim Investigational Site

Malmo, , Sweden

Site Status

248.525.46002 Boehringer Ingelheim Investigational Site

Nyköping, , Sweden

Site Status

248.525.46001 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

248.525.46004 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

248.525.38003 Boehringer Ingelheim Investigational Site

Dnipropetrovsk, , Ukraine

Site Status

248.525.38006 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

248.525.38002 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

248.525.38004 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

248.525.38001 Boehringer Ingelheim Investigational Site

Zaporizhzhya, , Ukraine

Site Status

248.525.38005 Boehringer Ingelheim Investigational Site

Zaporizhzhya, , Ukraine

Site Status

248.525.44005 Boehringer Ingelheim Investigational Site

Barnsley, , United Kingdom

Site Status

248.525.43005 Boehringer Ingelheim Investigational Site

Linz, , Austria

Site Status

248.525.42003 Boehringer Ingelheim Investigational Site

Pardubice, , Czechia

Site Status

248.525.42001 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

248.525.42005 Boehringer Ingelheim Investigational Site

Rakovník, , Czechia

Site Status

248.525.42002 Boehringer Ingelheim Investigational Site

Rychnov nad Kněžnou, , Czechia

Site Status

248.525.42004 Boehringer Ingelheim Investigational Site

Valašské Meziříčí, , Czechia

Site Status

248.525.36005 Boehringer Ingelheim Investigational Site

Győr, , Hungary

Site Status

248.525.36003 Boehringer Ingelheim Investigational Site

Kecskemét, , Hungary

Site Status

248.525.36006 Boehringer Ingelheim Investigational Site

Szeged, , Hungary

Site Status

248.525.36004 Boehringer Ingelheim Investigational Site

Veszprém, , Hungary

Site Status

248.525.91004 National Institute of Mental Health & Neuro Sciences

Bangalore, , India

Site Status

248.525.91002 Apollo Hospital

Chennai, , India

Site Status

248.525.91001 Institute of Human Behaviour & Allied Sciences

Delhi, , India

Site Status

248.525.91003 Nizam's Institute of Medical Sciences

Hyderabad, , India

Site Status

248.525.91007 Boehringer Ingelheim Investigational Site

Indore, , India

Site Status

248.525.91005 Mallikatta Neuro Research Center

Karnataka, , India

Site Status

248.525.91006 King Edward Memorial Hospital & Research Centre

Pune, , India

Site Status

248.525.39001 Policlinico di Catania

Catania, , Italy

Site Status

248.525.39010 Campus Universitario Germaneto

Catanzaro, , Italy

Site Status

248.525.39009 Ce.S.I.

Chieti, , Italy

Site Status

248.525.39007 Ospedale della Misericordia

Grosseto, , Italy

Site Status

248.525.39002 Università Federico II

Napoli, , Italy

Site Status

248.525.39008 Azienda Ospedaliera Pisana- Università degli Studi di Pisa

Pisa, , Italy

Site Status

248.525.44007 Boehringer Ingelheim Investigational Site

Blackburn, , United Kingdom

Site Status

248.525.44002 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

248.525.44004 Boehringer Ingelheim Investigational Site

Norwich, , United Kingdom

Site Status

248.525.44003 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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248.525

Identifier Type: -

Identifier Source: org_study_id

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