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

NCT00577460 | Completed Phase 3 Results

• 2 other identifiers: 248.6342007-004235-37
• Study Type: interventional
• Target: 391
• Locations: 14 countries
• Sites: 70

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).

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events

  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.

  80 weeks

Secondary Outcomes (31)

• Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III

  One week

• UPDRS II+III Change From Open Label (OL) Baseline

  OL Baseline and week 80

• Number of Participants With UPDRS II+III Response

  Week 80

• Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time

  One week

• Percentage Off Time During Waking Hours Total Score: Change From Baseline

  Baseline and week 80

Study Arms (2)

Pramipexole

ACTIVE COMPARATOR

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

Drug: Pramipexole

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Pramipexole DRUG

Pramipexole ER 0.375 -4.5 mg

Pramipexole

Placebo DRUG

Placebo tablets identical to Pramipexole ER tablets

Placebo

Eligibility Criteria

• Age: 32 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completion of the double-blind trial 248.525
• 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.
• 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.
• 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).

You may not qualify if:

• Patients prematurely withdrawn from the double-blind trial 248.525
• Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases
• 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
• History of psychosis, except history of drug induced hallucinations
• History of deep brain stimulation
• Clinically significant ECG abnormalities at baseline
• Clinically significant hypotension and/or symptomatic orthostatic hypotension at baseline
• Malignant melanoma or history of previously treated malignant melanoma
• 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
• Pregnancy or breast-feeding
• Sexually active female of childbearing potential not using a medically approved method of birth control
• 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
• Patients with a creatinine clearance \< 50 mL/min at baseline
• Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
• Any of the following drugs within 4 weeks prior to baseline visit: methylphenidate, cinnarizine, amphetamines

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (70)

248.634.43005 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

248.634.42003 Boehringer Ingelheim Investigational Site

Pardubice, Czechia

Location

248.634.42001 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

248.634.42005 Boehringer Ingelheim Investigational Site

Rakovník, Czechia

Location

248.634.42002 Boehringer Ingelheim Investigational Site

Rychnov nad Kněžnou, Czechia

Location

248.634.42004 Boehringer Ingelheim Investigational Site

Valašské Meziříčí, Czechia

Location

248.634.36005 Boehringer Ingelheim Investigational Site

Győr, Hungary

Location

248.634.36003 Boehringer Ingelheim Investigational Site

Kecskemét, Hungary

Location

248.634.36006 Boehringer Ingelheim Investigational Site

Szeged, Hungary

Location

248.634.36004 Boehringer Ingelheim Investigational Site

Veszprém, Hungary

Location

248.634.91002 Boehringer Ingelheim Investigational Site

Chennai, India

Location

248.634.91001 Boehringer Ingelheim Investigational Site

Delhi, India

Location

248.634.91003 Boehringer Ingelheim Investigational Site

Hyderabad, India

Location

248.634.91007 Boehringer Ingelheim Investigational Site

Indore, India

Location

248.634.91005 Boehringer Ingelheim Investigational Site

Karnataka, India

Location

248.634.91006 Boehringer Ingelheim Investigational Site

Pune, India

Location

248.634.39001 Boehringer Ingelheim Investigational Site

Catania, Italy

Location

248.634.39010 Boehringer Ingelheim Investigational Site

Catanzaro, Italy

Location

248.634.39009 Boehringer Ingelheim Investigational Site

Chieti, Italy

Location

248.634.39007 Boehringer Ingelheim Investigational Site

Grosseto, Italy

Location

248.634.39002 Boehringer Ingelheim Investigational Site

Napolii, Italy

Location

248.634.39008 Boehringer Ingelheim Investigational Site

Pisa, Italy

Location

248.634.39005 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

248.634.39011 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

248.634.63202 Boehringer Ingelheim Investigational Site

Cruz, Manila, Philippines

Location

248.634.63207 Boehringer Ingelheim Investigational Site

Ermita, Manila, Philippines

Location

248.634.63210 Boehringer Ingelheim Investigational Site

Makati City, Philippines

Location

248.634.63205 Boehringer Ingelheim Investigational Site

Manila, Philippines

Location

248.634.63206 Boehringer Ingelheim Investigational Site

Manila, Philippines

Location

248.634.63201 Boehringer Ingelheim Investigational Site

Pasig, Philippines

Location

248.634.63208 Boehringer Ingelheim Investigational Site

Quezon, Philippines

Location

248.634.63204 Boehringer Ingelheim Investigational Site

Quezon City, Philippines

Location

248.634.48001 Boehringer Ingelheim Investigational Site

Gdansk, Poland

Location

248.634.48003 Boehringer Ingelheim Investigational Site

Krakow, Poland

Location

248.634.48002 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

248.634.07001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

248.634.07002 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

248.634.07003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

248.634.07004 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

248.634.07007 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

248.634.07006 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

248.634.42104 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

248.634.42105 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

248.634.42103 Boehringer Ingelheim Investigational Site

Dubnica nad Váhom, Slovakia

Location

248.634.42101 Boehringer Ingelheim Investigational Site

Trnava, Slovakia

Location

248.634.82001 Boehringer Ingelheim Investigational Site

Gyeonggi-do, South Korea

Location

248.634.82008 Boehringer Ingelheim Investigational Site

Kyeonggi-do, South Korea

Location

248.634.82007 Boehringer Ingelheim Investigational Site

Pusan, South Korea

Location

248.634.82002 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

248.634.82003 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

248.634.82004 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

248.634.82005 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

248.634.82006 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

248.634.34001 Boehringer Ingelheim Investigational Site

Alcorcon (Madrid), Spain

Location

248.634.34003 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

248.634.34004 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

248.634.34005 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

248.634.34002 Boehringer Ingelheim Investigational Site

San Cugat Del Valles (Barcelona), Spain

Location

248.634.34008 Boehringer Ingelheim Investigational Site

Tarrasa (Barcelona), Spain

Location

248.634.46005 Boehringer Ingelheim Investigational Site

Malmo, Sweden

Location

248.634.46002 Boehringer Ingelheim Investigational Site

Nyköping, Sweden

Location

248.634.46001 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

248.634.38003 Boehringer Ingelheim Investigational Site

Dnipropetrovsk, Ukraine

Location

248.634.38006 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

248.634.38002 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

248.634.38004 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

248.634.38001 Boehringer Ingelheim Investigational Site

Zaporizhzhya, Ukraine

Location

248.634.38005 Boehringer Ingelheim Investigational Site

Zaporizhzhya, Ukraine

Location

248.634.44007 Boehringer Ingelheim Investigational Site

Blackburn, United Kingdom

Location

248.634.44003 Boehringer Ingelheim Investigational Site

Salford, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 20, 2007
• Study Start: December 1, 2007
• Primary Completion: June 1, 2010
• Last Updated: May 16, 2014
• Results First Posted: July 14, 2011

Record last verified: 2014-04

Locations

HU (4); IN (6); IT (8); SE (3); AU (1); UA (6); CZ (5); RU (6); SL (4); KR (8); PL (3); GB (2); PH (8); ES (6)