Parkinson DiseasePhase 3NCT00601523

Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).

A Phase 3 study testing Pramipexole in people with Parkinson Disease, run by Boehringer Ingelheim at 119 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Parkinson Disease
What is being tested?: Pramipexole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 511 participants
Where: 119 sitesin 15 countries
Study dates: Jan 2008to Jun 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Completion of the double-blind trial 248.524 or 248.636
Male or female patient with early idiopathic Parkinson´s disease (PD), and with a Modified Hoehn and Yahr stage of I to III.
Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
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).

Who cannot join

Patients prematurely withdrawn from the double-blind trials 248.524 or 248.636.
Atypical parkinsonian syndromes due to drugs,metabolic disorders, encephalitis or degenerative diseases.
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.

Trial locations and contacts

119 sites in 15 countries.

Country

City, postcode or hospital

119 sites in 15 countries

France32 sites

248.633.3303A Boehringer Ingelheim Investigational Site
Aix-en-Provence
248.633.3303B Boehringer Ingelheim Investigational Site
Aix-en-Provence
248.633.3303C Boehringer Ingelheim Investigational Site
Aix-en-Provence
248.633.3309A Boehringer Ingelheim Investigational Site
Clermont-Ferrand
248.633.3309B Boehringer Ingelheim Investigational Site
Clermont-Ferrand
248.633.3305A Boehringer Ingelheim Investigational Site
Créteil
248.633.3305B Boehringer Ingelheim Investigational Site
Créteil
248.633.3313A Boehringer Ingelheim Investigational Site
Dijon
248.633.3304A Boehringer Ingelheim Investigational Site
Évreux
248.633.3308A Boehringer Ingelheim Investigational Site
Lille
248.633.3308B Boehringer Ingelheim Investigational Site
Lille
248.633.3308C Boehringer Ingelheim Investigational Site
Lille
248.633.3308D Boehringer Ingelheim Investigational Site
Lille
248.633.3308E Boehringer Ingelheim Investigational Site
Lille
248.633.3302A Boehringer Ingelheim Investigational Site
Marseille
248.633.3302B Boehringer Ingelheim Investigational Site
Marseille
248.633.3302C Boehringer Ingelheim Investigational Site
Marseille
248.633.3306B Boehringer Ingelheim Investigational Site
Montpellier
248.633.3306C Boehringer Ingelheim Investigational Site
Montpellier
248.633.3306D Boehringer Ingelheim Investigational Site
Montpellier
248.633.3306F Boehringer Ingelheim Investigational Site
Montpellier
248.633.3306A Boehringer Ingelheim Investigational Site
Montpellier Cédex 5
248.633.3312A Boehringer Ingelheim Investigational Site
Rouen
248.633.3312B Boehringer Ingelheim Investigational Site
Rouen
248.633.3311A Boehringer Ingelheim Investigational Site
Strasbourg
248.633.3311B Boehringer Ingelheim Investigational Site
Strasbourg
248.633.3301A Boehringer Ingelheim Investigational Site
Toulouse
248.633.3301B Boehringer Ingelheim Investigational Site
Toulouse
248.633.3301C Boehringer Ingelheim Investigational Site
Toulouse
248.633.3301D Boehringer Ingelheim Investigational Site
Toulouse
248.633.3301F Boehringer Ingelheim Investigational Site
Toulouse
248.633.3301G Boehringer Ingelheim Investigational Site
Toulouse

Other trials in France

Germany15 sites

248.633.49009 Boehringer Ingelheim Investigational Site
Achim Bei Bremen
248.633.49002 Boehringer Ingelheim Investigational Site
Berlin
248.633.49004 Boehringer Ingelheim Investigational Site
Berlin
248.633.49018 Boehringer Ingelheim Investigational Site
Berlin
248.633.49019 Boehringer Ingelheim Investigational Site
Berlin
248.633.49005 Boehringer Ingelheim Investigational Site
Bochum
248.633.49016 Boehringer Ingelheim Investigational Site
Bochum
248.633.49007 Boehringer Ingelheim Investigational Site
Dresden
248.633.49011 Boehringer Ingelheim Investigational Site
Gera
248.633.49017 Boehringer Ingelheim Investigational Site
Karlsruhe
248.633.49001 Boehringer Ingelheim Investigational Site
Kassel
248.633.49012 Boehringer Ingelheim Investigational Site
Leipzig
248.633.49013 Boehringer Ingelheim Investigational Site
Marburg
248.633.49003 Boehringer Ingelheim Investigational Site
Steglitz
248.633.49015 Boehringer Ingelheim Investigational Site
Unterhaching

Other trials in Germany

Japan15 sites

248.633.81010 Boehringer Ingelheim Investigational Site
Aomori, Aomori
248.633.81001 Boehringer Ingelheim Investigational Site
Bunkyo-ku, Tokyo
248.633.81005 Boehringer Ingelheim Investigational Site
Fuchu, Tokyo
248.633.81011 Boehringer Ingelheim Investigational Site
Fujisawa, Kanagawa
248.633.81013 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka
248.633.81015 Boehringer Ingelheim Investigational Site
Iwamizawa,Hokkaido
248.633.81003 Boehringer Ingelheim Investigational Site
Kodaira, Tokyo
248.633.81014 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto
248.633.81009 Boehringer Ingelheim Investigational Site
Morioka, Iwate
248.633.81008 Boehringer Ingelheim Investigational Site
Okayama, Okayama
248.633.81006 Boehringer Ingelheim Investigational Site
Ota-ku, Tokyo
248.633.81004 Boehringer Ingelheim Investigational Site
Sagamihara, Kanagawa
248.633.81007 Boehringer Ingelheim Investigational Site
Shimogyo-ku, Kyoto, Kyoto
248.633.81012 Boehringer Ingelheim Investigational Site
Shiroishi, Miyagi
248.633.81002 Boehringer Ingelheim Investigational Site
Takamatsu, Kagawa

Other trials in Japan

United States10 sites

248.633.01010 Boehringer Ingelheim Investigational Site
Boca Raton, Florida
248.633.01009 Boehringer Ingelheim Investigational Site
Burlington, Vermont
248.633.01012 Boehringer Ingelheim Investigational Site
Chicago, Illinois
248.633.01005 Boehringer Ingelheim Investigational Site
Commack, New York
248.633.01008 Boehringer Ingelheim Investigational Site
Danbury, Connecticut
248.633.01001 Boehringer Ingelheim Investigational Site
Kansas City, Kansas
248.633.01016 Boehringer Ingelheim Investigational Site
La Jolla, California
248.633.01013 Boehringer Ingelheim Investigational Site
Oxnard, California
248.633.01004 Boehringer Ingelheim Investigational Site
Sun City, Arizona
248.633.01018 Boehringer Ingelheim Investigational Site
Tempe, Arizona

Other trials in United States

Hungary8 sites

248.633.36007 Boehringer Ingelheim Investigational Site
Eger
248.633.36005 Boehringer Ingelheim Investigational Site
Győr
248.633.36008 Boehringer Ingelheim Investigational Site
Miskolc
248.633.36004 Boehringer Ingelheim Investigational Site
Sopron
248.633.36001 Boehringer Ingelheim Investigational Site
Szeged
248.633.36006 Boehringer Ingelheim Investigational Site
Szeged
248.633.36003 Boehringer Ingelheim Investigational Site
Szombathely
248.633.36002 Boehringer Ingelheim Investigational Site
Zalaegerszeg

Other trials in Hungary

India7 sites

248.633.91002 Boehringer Ingelheim Investigational Site
Chennai
248.633.91009 Boehringer Ingelheim Investigational Site
Hyderabad
248.633.91001 Boehringer Ingelheim Investigational Site
Karnataka
248.633.91005 Boehringer Ingelheim Investigational Site
Maharashtra
248.633.91007 Boehringer Ingelheim Investigational Site
Maharashtra
248.633.91004 Boehringer Ingelheim Investigational Site
New Delhi
248.633.91011 Boehringer Ingelheim Investigational Site
Pune

Other trials in India

Ukraine6 sites

248.633.38005 Boehringer Ingelheim Investigational Site
Kiev
248.633.38001 Boehringer Ingelheim Investigational Site
Lviv
248.633.38002 Boehringer Ingelheim Investigational Site
Uzhhorod
248.633.38003 Boehringer Ingelheim Investigational Site
Vinnytzya
248.633.38004 Boehringer Ingelheim Investigational Site
Zaporizhzhya
248.633.38006 Boehringer Ingelheim Investigational Site
Zaporizhzhya

Other trials in Ukraine

Netherlands5 sites

248.633.31002 Boehringer Ingelheim Investigational Site
Geldrop
248.633.31003 Boehringer Ingelheim Investigational Site
Helmond
248.633.31006 Boehringer Ingelheim Investigational Site
Maastricht
248.633.31004 Boehringer Ingelheim Investigational Site
Nijmegen
248.633.31001 Boehringer Ingelheim Investigational Site
Sittard-geleen

Other trials in Netherlands

Russia5 sites

248.633.07001 Boehringer Ingelheim Investigational Site
Moscow
248.633.07002 Boehringer Ingelheim Investigational Site
Moscow
248.633.07003 Boehringer Ingelheim Investigational Site
Moscow
248.633.07004 Boehringer Ingelheim Investigational Site
Moscow
248.633.07006 Boehringer Ingelheim Investigational Site
Saint Petersburg

Other trials in Russia

Czechia4 sites

248.633.42004 Boehringer Ingelheim Investigational Site
Olomouc
248.633.42003 Boehringer Ingelheim Investigational Site
Pardubice
248.633.42001 Boehringer Ingelheim Investigational Site
Prague
248.633.42002 Boehringer Ingelheim Investigational Site
Rychnov nad Kněžnou

Other trials in Czechia

Taiwan4 sites

248.633.88603 Boehringer Ingelheim Investigational Site
Kaohsiung City
248.633.88605 Boehringer Ingelheim Investigational Site
Taichung
248.633.88601 Boehringer Ingelheim Investigational Site
Taipei
248.633.88602 Boehringer Ingelheim Investigational Site
Taoyuan

Other trials in Taiwan

Finland3 sites

248.633.35803 Boehringer Ingelheim Investigational Site
Hyvinkää
248.633.35801 Boehringer Ingelheim Investigational Site
Oulu
248.633.35802 Boehringer Ingelheim Investigational Site
Tampere

Other trials in Finland

Austria2 sites

248.633.43001 Boehringer Ingelheim Investigational Site
Innsbruck
248.633.43004 Boehringer Ingelheim Investigational Site
Vienna

Other trials in Austria

Slovakia2 sites

248.633.42103 Boehringer Ingelheim Investigational Site
Dubnica nad Váhom
248.633.42101 Boehringer Ingelheim Investigational Site
Trnava

Other trials in Slovakia

Malaysia1 site

248.633.60004 Boehringer Ingelheim Investigational Site
Kuala Terengganu

Other trials in Malaysia

About this study

Conditions: Parkinson Disease
Being tested: Placebo, Pramipexole
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase.
PramipexoleDrug
ER 0.375-4,5 mg

Study groups in NCT00601523
Study group	Role	What they receive
Pramipexole	Active comparator	Patient to receive Pramipexole ER 0.375-4.5 mg tabl form daily Receives: Drug: Pramipexole
Placebo	Placebo comparator	Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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 early PD (248.524 (NCT00479401) or 248.636 (NCT00558025)). Therefore these items were considered as a safety evaluation
Measured: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)

Secondary outcomes (13)

Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline
UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Measured: Open Label (OL) baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
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)
A response means an improvement of >=20% from OL baseline. UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Measured: OL Baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
UPDRS I Total Score: Change From OL Baseline
UPDRS I ranging from 0 (normal) to 16 (severe), measures Mentation, Behavior and Mood
Measured: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
UPDRS II Total Score: Change From OL Baseline
UPDRS II ranging from 0 (normal) to 52 (severe), measures activity of daily living.
Measured: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
UPDRS III Total Score: Change From OL Baseline
UPDRS III ranging from 0 (normal) to 108 (severe) measures motor symptoms
Measured: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
Response in Clinical Global Impression of Improvement (CGI-I)
Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least "much improved" were considered as responders. For patients previously treated with Pramipexole ER or Immediate Release (IR), all patients with no change to very much improved were considered as responders
Measured: OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)
Response in Patient Global Impression of Improvement (PGI-I)
Patient rated evaluation of the PD symptoms on a rating scale of 7 steps, 1 meaning very much better to 7 meaning very much worse. For patients previously treated with Placebo, all patients with at least "much better" were considered as responders. For patients previously treated with pramipexole (PPX) ER or IR, all patients with no change to very much better were considered as responders
Measured: OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)
Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline
PFS-16 ranging from 16 (better perceived health status) to 80 (severe symptoms of the disease) measuring aspects of fatigue that are relevant to patients with PD.
Measured: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
Number of Patients Introducing L-Dopa Medication in OL Trial
Number of patients requiring Levodopa supplementation during the study
Measured: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)
L-Dopa Dose: Change From OL Baseline
Change from open-label baseline in Levodopa dose
Measured: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
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
Change from open-label baseline in Levodopa dose over the final 72 weeks of open-label assessment
Measured: Week 8 and week 80 (patients from 248.524) or week 0 and week 72 (patients from 248.636)
Patient Preference Regarding Treatment Dosing
Patients were surveyed on their preference for Once Daily dosing versus Three Times Daily dosing
Measured: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)
Patient Rating of Convenience of Treatment Dosing
Patients were surveyed on the convenience of Once Daily dosing versus Three Times Daily dosing
Measured: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Jun 2010

First posted28 Jan 2008 (estimated)
Study startJan 2008
Primary completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 511 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00601523
Sponsor's protocol ID: 248.633
Other IDs: 2007-004234-16
Status last verified: Mar 2014
First submitted: 15 Jan 2008
Last updated: 9 Jun 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).
ClinicalTrials.gov ID: NCT00601523
Acronym / sponsor ID: 248.633
Conditions: Parkinson Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 511 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Jun 2010 (actual)
First posted: 28 Jan 2008 (estimated)
Results: Posted 25 Aug 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Pramipexole	Active comparator	Drug: PramipexolePatient to receive Pramipexole ER 0.375-4.5 mg tabl form daily
Placebo	Placebo comparator	Drug: PlaceboPatient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase.

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Completion of the double-blind trial 248.524 or 248.636
Male or female patient with early idiopathic Parkinson´s disease (PD), and with a Modified Hoehn and Yahr stage of I to III.
Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
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).

Key exclusion criteria (8 listed)

Patients prematurely withdrawn from the double-blind trials 248.524 or 248.636.
Atypical parkinsonian syndromes due to drugs,metabolic disorders, encephalitis or degenerative diseases.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboPatient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase.	Drug	Placebo
PramipexoleER 0.375-4,5 mg	Drug	Pramipexole

Primary outcome

Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Time frame: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)
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 early PD (248.524 (NCT00479401) or 248.636 (NCT00558025)). Therefore these items were considered as a safety evaluation

13 secondary outcomes

Unified Parkinson's Disease Rating Scale (UPDRS) II+III Total Score: Change From Baseline
Time frame: Open Label (OL) baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
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)
Time frame: OL Baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
UPDRS I Total Score: Change From OL Baseline
Time frame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
UPDRS II Total Score: Change From OL Baseline
Time frame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
UPDRS III Total Score: Change From OL Baseline
Time frame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
Response in Clinical Global Impression of Improvement (CGI-I)
Time frame: OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)
Response in Patient Global Impression of Improvement (PGI-I)
Time frame: OL Baseline and week 32 (patients from 248.524) or week 24 (patients from 248.636)
Parkinson Fatigue Scale (PFS-16) : Change From OL Baseline
Time frame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
Number of Patients Introducing L-Dopa Medication in OL Trial
Time frame: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)
L-Dopa Dose: Change From OL Baseline
Time frame: OL baseline and week 80 (patients from 248.524) or week 72 (patients from 248.636)
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
Time frame: Week 8 and week 80 (patients from 248.524) or week 0 and week 72 (patients from 248.636)
Patient Preference Regarding Treatment Dosing
Time frame: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)
Patient Rating of Convenience of Treatment Dosing
Time frame: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)

Results and safety

Results posted to the registry on 25 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients From 248.524	368	291
Patients From 248.636	143	117

Primary outcome: Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events

Time frame: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636). Number. Unit: Percentage of participants

Measure	Patients From 248.524 n = 368	Patients From 248.636 n = 143
Percentage of Patients with Adverse Events	84.5	76.2
Percentage of Patients with Adverse Drug Reactions	45.7	23.1
Percentage of Patients with Serious Adverse Events	14.4	14.7

Population analysed: Patients from Treated Set (defined as all patients who were dispensed study drug and were documented to have at least one dose of investigational treatment)

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 80 weeks for patients from 248.524, Up to 72 weeks for patients from 248.636. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients From 248.524	53 of 368 (14.4%)	214 of 368 (58.2%)	Not reported
Patients From 248.636	21 of 143 (14.7%)	62 of 143 (43.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Enrolling by invitationObservational study
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PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

119 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pramipexole in people with Parkinson Disease, run by Boehringer Ingelheim at 119 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in France, Germany, Japan, United States, Hungary and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events (time frame: 80 weeks (patients from 248.524) or 72 weeks (patients from 248.636)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00601523.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2014.