Clinical trial NCT00601523: Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).
Official title: Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 511
Sex: ALL
Minimum age (years): 30
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 ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or 248.636(NCT00558025) trial).


Eligibility criteria: Inclusion criteria:

1. Completion of the double-blind trial 248.524 or 248.636
2. Male or female patient with early idiopathic Parkinson´s disease (PD), and with a Modified Hoehn and Yahr stage of I to III.
3. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
4. Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) guidelines and local legislation).

Exclusion criteria:

1. Patients prematurely withdrawn from the double-blind trials 248.524 or 248.636.
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, fourth edition (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. Clinically significant electrocardiogram (ECG) abnormalities at baseline. 6.Clinically significant hypotension 7.Malignant melanoma or history of previously treated malignant melanoma. 8.Any other clinically significant disease, that could put the patient at risk or could prevent compliance or completion of the study. 9. Pregnancy or breast-feeding.

10. Sexually active female of childbearing potential not using a medically approved method of birth control for at least one month prior to the baseline and throughout the study.11 Serum levels of aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), alkaline phosphatase or bilirubin \> 2 upper limit of normal (ULN) at baseline 12. Patients with a creatinine clearance \< 50 mL/min (estimated by the Cockcroft and Gault formula). 13. Motor complications under levodopa therapy (e.g. on-off phenomena, dyskinesia) at baseline.

14. Any medication (including intra-muscular formulations) 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: methylphenidate, cinnarizine, amphetamines. 16. Flunarizine within 3 months prior to baseline.

17. Known hypersensitivity to pramipexole or its excipients. 18. Drug abuse (including alcohol), according to investigator´s judgement, within 2 years prior to baseline.

19. Participation in investigational drug studies other than trials 248.524 and 248.636 or use of other investigational drug within one month or five times the half-life of the investigational drug prior to baseline.

Primary outcomes:
measure: Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
timeFrame: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline
timeFrame: Open Label (OL) baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
measure: Number of Patients With UPDRS II+III Response From OL Baseline at Week 80 (Patients From 248.524) or Week 72 (Patients From 248.636)
timeFrame: OL Baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
measure: UPDRS I Total Score: Change From OL Baseline
timeFrame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
measure: UPDRS II Total Score: Change From OL Baseline
timeFrame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
measure: UPDRS III Total Score: Change From OL Baseline
timeFrame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
measure: Response in Clinical Global Impression of Improvement (CGI-I)
timeFrame: OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)
measure: Response in Patient Global Impression of Improvement (PGI-I)
timeFrame: OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)
measure: Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline
timeFrame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
measure: Number of Patients Introducing L-Dopa Medication in OL Trial
timeFrame: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)
measure: L-Dopa Dose: Change From OL Baseline
timeFrame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
measure: Pramipexole Doses Respectively After 80 Weeks Compared to Pramipexole Doses at Week 8 for Previously 248.524 Patients and After 72 Weeks Compared to Pramipexole Doses at Week 0 for Previously 248.636 Patients
timeFrame: Week 8 and week 80 (patients from 248.524) or week 0 and week 72 (patients from 248.636)
measure: Patient Preference Regarding Treatment Dosing
timeFrame: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)
measure: Patient Rating of Convenience of Treatment Dosing
timeFrame: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)
Other outcomes:
Locations:
city: Sun City
country: United States
facility: 248.633.01004 Boehringer Ingelheim Investigational Site
state: Arizona
city: Tempe
country: United States
facility: 248.633.01018 Boehringer Ingelheim Investigational Site
state: Arizona
city: La Jolla
country: United States
facility: 248.633.01016 Boehringer Ingelheim Investigational Site
state: California
city: Oxnard
country: United States
facility: 248.633.01013 Boehringer Ingelheim Investigational Site
state: California
city: Danbury
country: United States
facility: 248.633.01008 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Boca Raton
country: United States
facility: 248.633.01010 Boehringer Ingelheim Investigational Site
state: Florida
city: Chicago
country: United States
facility: 248.633.01012 Boehringer Ingelheim Investigational Site
state: Illinois
city: Kansas City
country: United States
facility: 248.633.01001 Boehringer Ingelheim Investigational Site
state: Kansas
city: Commack
country: United States
facility: 248.633.01005 Boehringer Ingelheim Investigational Site
state: New York
city: Burlington
country: United States
facility: 248.633.01009 Boehringer Ingelheim Investigational Site
state: Vermont
city: Innsbruck
country: Austria
facility: 248.633.43001 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 248.633.43004 Boehringer Ingelheim Investigational Site
city: Olomouc
country: Czech Republic
facility: 248.633.42004 Boehringer Ingelheim Investigational Site
city: Pardubice
country: Czech Republic
facility: 248.633.42003 Boehringer Ingelheim Investigational Site
city: Praha
country: Czech Republic
facility: 248.633.42001 Boehringer Ingelheim Investigational Site
city: Rychnov nad Kneznou
country: Czech Republic
facility: 248.633.42002 Boehringer Ingelheim Investigational Site
city: Hyvinkää
country: Finland
facility: 248.633.35803 Boehringer Ingelheim Investigational Site
city: Oulu
country: Finland
facility: 248.633.35801 Boehringer Ingelheim Investigational Site
city: Tampere
country: Finland
facility: 248.633.35802 Boehringer Ingelheim Investigational Site
city: Aix en Provence
country: France
facility: 248.633.3303A Boehringer Ingelheim Investigational Site
city: Aix en Provence
country: France
facility: 248.633.3303B Boehringer Ingelheim Investigational Site
city: Aix en Provence
country: France
facility: 248.633.3303C Boehringer Ingelheim Investigational Site
city: Clermont Ferrand
country: France
facility: 248.633.3309A Boehringer Ingelheim Investigational Site
city: Clermont Ferrand
country: France
facility: 248.633.3309B Boehringer Ingelheim Investigational Site
city: Créteil
country: France
facility: 248.633.3305A Boehringer Ingelheim Investigational Site
city: Créteil
country: France
facility: 248.633.3305B Boehringer Ingelheim Investigational Site
city: Dijon cedex
country: France
facility: 248.633.3313A Boehringer Ingelheim Investigational Site
city: Evreux
country: France
facility: 248.633.3304A Boehringer Ingelheim Investigational Site
city: Lille cedex
country: France
facility: 248.633.3308A Boehringer Ingelheim Investigational Site
city: Lille cedex
country: France
facility: 248.633.3308B Boehringer Ingelheim Investigational Site
city: Lille cedex
country: France
facility: 248.633.3308C Boehringer Ingelheim Investigational Site
city: Lille cedex
country: France
facility: 248.633.3308D Boehringer Ingelheim Investigational Site
city: Lille cedex
country: France
facility: 248.633.3308E Boehringer Ingelheim Investigational Site
city: Marseille cedex 5
country: France
facility: 248.633.3302A Boehringer Ingelheim Investigational Site
city: Marseille cedex 5
country: France
facility: 248.633.3302B Boehringer Ingelheim Investigational Site
city: Marseille cedex 5
country: France
facility: 248.633.3302C Boehringer Ingelheim Investigational Site
city: Montpellier cédex 5
country: France
facility: 248.633.3306A Boehringer Ingelheim Investigational Site
city: Montpellier
country: France
facility: 248.633.3306B Boehringer Ingelheim Investigational Site
city: Montpellier
country: France
facility: 248.633.3306C Boehringer Ingelheim Investigational Site
city: Montpellier
country: France
facility: 248.633.3306D Boehringer Ingelheim Investigational Site
city: Montpellier
country: France
facility: 248.633.3306F Boehringer Ingelheim Investigational Site
city: Rouen
country: France
facility: 248.633.3312A Boehringer Ingelheim Investigational Site
city: Rouen
country: France
facility: 248.633.3312B Boehringer Ingelheim Investigational Site
city: Strasbourg
country: France
facility: 248.633.3311A Boehringer Ingelheim Investigational Site
city: Strasbourg
country: France
facility: 248.633.3311B Boehringer Ingelheim Investigational Site
city: Toulouse Cedex 7
country: France
facility: 248.633.3301C Boehringer Ingelheim Investigational Site
city: Toulouse cedex
country: France
facility: 248.633.3301B Boehringer Ingelheim Investigational Site
city: Toulouse
country: France
facility: 248.633.3301A Boehringer Ingelheim Investigational Site
city: Toulouse
country: France
facility: 248.633.3301D Boehringer Ingelheim Investigational Site
city: Toulouse
country: France
facility: 248.633.3301F Boehringer Ingelheim Investigational Site
city: Toulouse
country: France
facility: 248.633.3301G Boehringer Ingelheim Investigational Site
city: Achim bei Bremen
country: Germany
facility: 248.633.49009 Boehringer Ingelheim Investigational Site
city: Berlin-Steglitz
country: Germany
facility: 248.633.49003 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 248.633.49002 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 248.633.49004 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 248.633.49018 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 248.633.49019 Boehringer Ingelheim Investigational Site
city: Bochum
country: Germany
facility: 248.633.49005 Boehringer Ingelheim Investigational Site
city: Bochum
country: Germany
facility: 248.633.49016 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 248.633.49007 Boehringer Ingelheim Investigational Site
city: Gera
country: Germany
facility: 248.633.49011 Boehringer Ingelheim Investigational Site
city: Karlsruhe
country: Germany
facility: 248.633.49017 Boehringer Ingelheim Investigational Site
city: Kassel
country: Germany
facility: 248.633.49001 Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: 248.633.49012 Boehringer Ingelheim Investigational Site
city: Marburg
country: Germany
facility: 248.633.49013 Boehringer Ingelheim Investigational Site
city: Unterhaching
country: Germany
facility: 248.633.49015 Boehringer Ingelheim Investigational Site
city: Eger
country: Hungary
facility: 248.633.36007 Boehringer Ingelheim Investigational Site
city: Györ
country: Hungary
facility: 248.633.36005 Boehringer Ingelheim Investigational Site
city: Miskolc
country: Hungary
facility: 248.633.36008 Boehringer Ingelheim Investigational Site
city: Sopron
country: Hungary
facility: 248.633.36004 Boehringer Ingelheim Investigational Site
city: Szeged
country: Hungary
facility: 248.633.36001 Boehringer Ingelheim Investigational Site
city: Szeged
country: Hungary
facility: 248.633.36006 Boehringer Ingelheim Investigational Site
city: Szombathely
country: Hungary
facility: 248.633.36003 Boehringer Ingelheim Investigational Site
city: Zalaegerszeg
country: Hungary
facility: 248.633.36002 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 248.633.91002 Boehringer Ingelheim Investigational Site
city: Hyderabad
country: India
facility: 248.633.91009 Boehringer Ingelheim Investigational Site
city: Karnataka
country: India
facility: 248.633.91001 Boehringer Ingelheim Investigational Site
city: Maharashtra
country: India
facility: 248.633.91005 Boehringer Ingelheim Investigational Site
city: Maharashtra
country: India
facility: 248.633.91007 Boehringer Ingelheim Investigational Site
city: New Delhi
country: India
facility: 248.633.91004 Boehringer Ingelheim Investigational Site
city: Pune
country: India
facility: 248.633.91011 Boehringer Ingelheim Investigational Site
city: Aomori, Aomori
country: Japan
facility: 248.633.81010 Boehringer Ingelheim Investigational Site
city: Bunkyo-ku, Tokyo
country: Japan
facility: 248.633.81001 Boehringer Ingelheim Investigational Site
city: Fuchu, Tokyo
country: Japan
facility: 248.633.81005 Boehringer Ingelheim Investigational Site
city: Fujisawa, Kanagawa
country: Japan
facility: 248.633.81011 Boehringer Ingelheim Investigational Site
city: Fukuoka, Fukuoka
country: Japan
facility: 248.633.81013 Boehringer Ingelheim Investigational Site
city: Iwamizawa,Hokkaido
country: Japan
facility: 248.633.81015 Boehringer Ingelheim Investigational Site
city: Kodaira, Tokyo
country: Japan
facility: 248.633.81003 Boehringer Ingelheim Investigational Site
city: Kyoto, Kyoto
country: Japan
facility: 248.633.81014 Boehringer Ingelheim Investigational Site
city: Morioka, Iwate
country: Japan
facility: 248.633.81009 Boehringer Ingelheim Investigational Site
city: Okayama, Okayama
country: Japan
facility: 248.633.81008 Boehringer Ingelheim Investigational Site
city: Ota-ku, Tokyo
country: Japan
facility: 248.633.81006 Boehringer Ingelheim Investigational Site
city: Sagamihara, Kanagawa
country: Japan
facility: 248.633.81004 Boehringer Ingelheim Investigational Site
city: Shimogyo-ku, Kyoto, Kyoto
country: Japan
facility: 248.633.81007 Boehringer Ingelheim Investigational Site
city: Shiroishi, Miyagi
country: Japan
facility: 248.633.81012 Boehringer Ingelheim Investigational Site
city: Takamatsu, Kagawa
country: Japan
facility: 248.633.81002 Boehringer Ingelheim Investigational Site
city: Kuala Terengganu
country: Malaysia
facility: 248.633.60004 Boehringer Ingelheim Investigational Site
city: Geldrop
country: Netherlands
facility: 248.633.31002 Boehringer Ingelheim Investigational Site
city: Helmond
country: Netherlands
facility: 248.633.31003 Boehringer Ingelheim Investigational Site
city: Maastricht
country: Netherlands
facility: 248.633.31006 Boehringer Ingelheim Investigational Site
city: Nijmegen
country: Netherlands
facility: 248.633.31004 Boehringer Ingelheim Investigational Site
city: Sittard-geleen
country: Netherlands
facility: 248.633.31001 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 248.633.07001 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 248.633.07002 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 248.633.07003 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 248.633.07004 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 248.633.07006 Boehringer Ingelheim Investigational Site
city: Dubnica nad Vahom
country: Slovakia
facility: 248.633.42103 Boehringer Ingelheim Investigational Site
city: Trnava
country: Slovakia
facility: 248.633.42101 Boehringer Ingelheim Investigational Site
city: Kaohsiung
country: Taiwan
facility: 248.633.88603 Boehringer Ingelheim Investigational Site
city: Taichung
country: Taiwan
facility: 248.633.88605 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 248.633.88601 Boehringer Ingelheim Investigational Site
city: Taoyuan
country: Taiwan
facility: 248.633.88602 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 248.633.38005 Boehringer Ingelheim Investigational Site
city: Lvov
country: Ukraine
facility: 248.633.38001 Boehringer Ingelheim Investigational Site
city: Uzhgorod
country: Ukraine
facility: 248.633.38002 Boehringer Ingelheim Investigational Site
city: Vinnytzya
country: Ukraine
facility: 248.633.38003 Boehringer Ingelheim Investigational Site
city: Zaporizhzhya
country: Ukraine
facility: 248.633.38004 Boehringer Ingelheim Investigational Site
city: Zaporozhye
country: Ukraine
facility: 248.633.38006 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: