Parkinson DiseasePhase 3NCT00466167

Pivotal Study in Advanced Parkinsons Disease Patients

A Phase 3 study testing Pramipexol Extended Release and Pramipexol Immediate Release in people with Parkinson Disease, run by Boehringer Ingelheim at 76 sites in 14 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

Who is it for?: Ages 32 years and older
Conditions the study is for: Parkinson Disease
What is being tested?: Pramipexol Extended Release and Pramipexol Immediate Release
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 517 participants
Where: 76 sitesin 14 countries
Study dates: Apr 2007to Nov 2008
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 32 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patient with advanced idiopathic Parkinsons disease confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
Parkinsons disease diagnosed for at least 2 years.
Patients 30 years of age or older at the time of diagnosis.
Modified Hoehn and Yahr stage of 2 to 4 at on-time.
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.
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).
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.
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).

Who cannot join

Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases
Dementia, as defined by a Mini-Mental State Exam score < 24 at screening visit
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
History of psychosis, except history of drug induced hallucinations
History of deep brain stimulation
Clinically significant Electrocardiogram abnormalities at screening visit

Show all 20Show fewer

Clinically significant hypotension and/or symptomatic orthostatic hypotension at screening or baseline visit
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 for at least one month prior to the screening visit and throughout the study period
Serum levels of Aspartate Aminotransferase (Serum Glutamic-Oxaloacetic Transaminase), Alanine Aminotransferase (Serum Glutamic Pyruvic Transaminase), alkaline phosphatases or bilirubin > 2 Upper Limit of Normal
Patients with a creatinine clearance < 50 millilitres/minute
Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit
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
Flunarizine within 3 months prior to baseline visit
Known hypersensitivity to pramipexole or its excipients
Drug abuse according to investigators judgement, within 2 years prior to screening
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

Trial locations and contacts

76 sites in 14 countries.

Country

City, postcode or hospital

76 sites in 14 countries

Italy8 sites

248.525.39001 Policlinico di Catania
Catania
248.525.39010 Campus Universitario Germaneto
Catanzaro
248.525.39009 Ce.S.I.
Chieti
248.525.39007 Ospedale della Misericordia
Grosseto
248.525.39002 Università Federico II
Naples
248.525.39008 Azienda Ospedaliera Pisana- Università degli Studi di Pisa
Pisa
248.525.39005 Università La Sapienza di Roma
Roma
248.525.39011 Policlinico Tor Vergata
Roma

Other trials in Italy

Philippines8 sites

248.525.63210 Makati Medical Center
Makati City
248.525.63202 Chinese General Hospital
Manila
248.525.63205 Jose Reyes Memorial Medical Center
Manila
248.525.63206 Metropolitan Medical Center
Manila
248.525.63207 Manila Doctors Hospital
Manila
248.525.63201 The Medical City
Pasig
248.525.63204 St Lukes Medical Center
Quezon
248.525.63208 University of the East Ramon Magsaysay Memorial Medical Ctr
Quezon

Other trials in Philippines

South Korea8 sites

248.525.82001 Boehringer Ingelheim Investigational Site
Gyeonggi-do
248.525.82008 Boehringer Ingelheim Investigational Site
Kyeonggi-do
248.525.82007 Boehringer Ingelheim Investigational Site
Pusan
248.525.82002 Boehringer Ingelheim Investigational Site
Seoul
248.525.82003 Boehringer Ingelheim Investigational Site
Seoul
248.525.82004 Boehringer Ingelheim Investigational Site
Seoul
248.525.82005 Boehringer Ingelheim Investigational Site
Seoul
248.525.82006 Boehringer Ingelheim Investigational Site
Seoul

Other trials in South Korea

India7 sites

248.525.91004 National Institute of Mental Health & Neuro Sciences
Bangalore
248.525.91002 Apollo Hospital
Chennai
248.525.91001 Institute of Human Behaviour & Allied Sciences
Delhi
248.525.91003 Nizam's Institute of Medical Sciences
Hyderabad
248.525.91007 Boehringer Ingelheim Investigational Site
Indore
248.525.91005 Mallikatta Neuro Research Center
Karnataka
248.525.91006 King Edward Memorial Hospital & Research Centre
Pune

Other trials in India

Russia7 sites

248.525.07001 Boehringer Ingelheim Investigational Site
Moscow
248.525.07002 Boehringer Ingelheim Investigational Site
Moscow
248.525.07003 Boehringer Ingelheim Investigational Site
Moscow
248.525.07004 Boehringer Ingelheim Investigational Site
Moscow
248.525.07007 Boehringer Ingelheim Investigational Site
Moscow
248.525.07005 Boehringer Ingelheim Investigational Site
Saint Petersburg
248.525.07006 Boehringer Ingelheim Investigational Site
Saint Petersburg

Other trials in Russia

Spain6 sites

248.525.34001 Boehringer Ingelheim Investigational Site
Alcorcon (Madrid)
248.525.34003 Boehringer Ingelheim Investigational Site
Barcelona
248.525.34004 Boehringer Ingelheim Investigational Site
Barcelona
248.525.34005 Boehringer Ingelheim Investigational Site
Madrid
248.525.34002 Boehringer Ingelheim Investigational Site
San Cugat Del Valles (Barcelona)
248.525.34008 Boehringer Ingelheim Investigational Site
Tarrasa (Barcelona)

Other trials in Spain

Ukraine6 sites

248.525.38003 Boehringer Ingelheim Investigational Site
Dnipropetrovsk
248.525.38006 Boehringer Ingelheim Investigational Site
Kharkiv
248.525.38002 Boehringer Ingelheim Investigational Site
Kiev
248.525.38004 Boehringer Ingelheim Investigational Site
Kiev
248.525.38001 Boehringer Ingelheim Investigational Site
Zaporizhzhya
248.525.38005 Boehringer Ingelheim Investigational Site
Zaporizhzhya

Other trials in Ukraine

Czechia5 sites

248.525.42003 Boehringer Ingelheim Investigational Site
Pardubice
248.525.42001 Boehringer Ingelheim Investigational Site
Prague
248.525.42005 Boehringer Ingelheim Investigational Site
Rakovník
248.525.42002 Boehringer Ingelheim Investigational Site
Rychnov nad Kněžnou
248.525.42004 Boehringer Ingelheim Investigational Site
Valašské Meziříčí

Other trials in Czechia

United Kingdom5 sites

248.525.44005 Boehringer Ingelheim Investigational Site
Barnsley
248.525.44007 Boehringer Ingelheim Investigational Site
Blackburn
248.525.44002 Boehringer Ingelheim Investigational Site
London
248.525.44004 Boehringer Ingelheim Investigational Site
Norwich
248.525.44003 Boehringer Ingelheim Investigational Site
Salford

Other trials in United Kingdom

Hungary4 sites

248.525.36005 Boehringer Ingelheim Investigational Site
Győr
248.525.36003 Boehringer Ingelheim Investigational Site
Kecskemét
248.525.36006 Boehringer Ingelheim Investigational Site
Szeged
248.525.36004 Boehringer Ingelheim Investigational Site
Veszprém

Other trials in Hungary

Slovakia4 sites

248.525.42104 Boehringer Ingelheim Investigational Site
Bratislava
248.525.42105 Boehringer Ingelheim Investigational Site
Bratislava
248.525.42103 Boehringer Ingelheim Investigational Site
Dubnica nad Váhom
248.525.42101 Boehringer Ingelheim Investigational Site
Trnava

Other trials in Slovakia

Sweden4 sites

248.525.46005 Boehringer Ingelheim Investigational Site
Malmö
248.525.46002 Boehringer Ingelheim Investigational Site
Nyköping
248.525.46001 Boehringer Ingelheim Investigational Site
Stockholm
248.525.46004 Boehringer Ingelheim Investigational Site
Stockholm

Other trials in Sweden

Poland3 sites

248.525.48001 Boehringer Ingelheim Investigational Site
Gdansk
248.525.48003 Boehringer Ingelheim Investigational Site
Krakow
248.525.48002 Wolski Hospital Dr. Anna Gostynska
Warsaw

Other trials in Poland

Austria1 site

248.525.43005 Boehringer Ingelheim Investigational Site
Linz

Other trials in Austria

About this study

Official title: A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD).

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.

Conditions: Parkinson Disease
Being tested: Pramipexol Extended Release, Pramipexol Immediate Release, Placebo
Medical subject headings: Parkinson Disease

What participants receive

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

Pramipexol Extended ReleaseDrug
Pramipexol Immediate ReleaseDrug
PlaceboDrug

Study groups in NCT00466167
Study group	Role	What they receive
Pramipexole ER	Other	Not described Receives: Drug: Pramipexol Extended Release
Pramipexole IR	Other	Not described Receives: Drug: Pramipexol Immediate Release
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Score at Week 18
UPDRS II+III total score on Full Analysis Set (FAS)with LOCF (Last observation carried forward), week 18 - 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: baseline and week 18

Secondary outcomes (16)

Change From Baseline in Percentage Off-time at Week 18
Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).
Measured: baseline and week 18
Change From Baseline in Percentage On-time Without Dyskinesia at Week 18
Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Measured: baseline and week 18
Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18
Percentage on-time with non-troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Measured: baseline and week 18
Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18
Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.
Measured: baseline and week 18
Clinical Global Impression - Global Improvement (CGI-I) Responder
CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved)
Measured: after 18 weeks of treatment
Response in Patient Global Impression (PGI-I)
PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring 1 or 2 (at least much better)
Measured: after 18 weeks of treatment
Change From Baseline in UPDRS I Score After 18 Weeks
UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood
Measured: baseline and 18 weeks
Change From Baseline in UPDRS II Score After 18 Weeks, Average at on and Off-period
UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities.
Measured: baseline and 18 weeks
Change From Baseline in UPDRS III Score After 18 Weeks
UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms
Measured: baseline and 18 weeks
Change From Baseline in UPDRS IV Score After 18 Weeks
UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy
Measured: baseline and 18 weeks
Change From Baseline in Beck's Depression Inventory (BDI) After 18 Weeks
ranging from 0 (best case) to 63 (worst case)
Measured: baseline and 18 weeks
Change From Baseline in Parkinson's Disease Sleep Scale (PDSS) After 18 Weeks
ranging from 0 (worst case) to 150 (best case)
Measured: baseline and 18 weeks
Change From Baseline in Parkinson's Disease Quality of Life Questionnaire 39 After 18 Weeks
Ranging from 0 (best case) to 156 (worst case)
Measured: baseline and 18 weeks
Change From Baseline in European Quality of Life (EuroQol) Scale After 18 Weeks
ranging from 0 (worst case) to 100 (best case)
Measured: baseline and 18 weeks
Change From Baseline in 11-point Likert Scale for Pain Related to PD at Week 18
Likert scale is a method used for the measurement of pain. The patients were asked to rate their pain related to PD by ticking the number that best described their pain on the average in the previous week, from zero for "no pain" to ten for "unbearable pain".
Measured: baseline and week 18
Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)
Measured: baseline and week 18

Timeline

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

Apr 2007Nov 2008

First posted27 Apr 2007 (estimated)
Study startApr 2007
Primary completionNov 2008

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
Intervention model: Parallel groups
Enrolment: 517 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00466167
Sponsor's protocol ID: 248.525
Status last verified: May 2014
First submitted: 25 Apr 2007
Last updated: 8 Jul 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD).
ClinicalTrials.gov ID: NCT00466167
Acronym / sponsor ID: 248.525
Conditions: Parkinson Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 517 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Nov 2008 (actual)
First posted: 27 Apr 2007 (estimated)
Results: Posted 8 Feb 2010

Clinical summary

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

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.

Study design

Primary purpose: Treatment
Intervention model: Parallel groups
Number of arms: 3

Arm	Type	Receives
Pramipexole ER	Other	Drug: Pramipexol Extended Release
Pramipexole IR	Other	Drug: Pramipexol Immediate Release
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 32 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male or female patient with advanced idiopathic Parkinsons disease confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
Parkinsons disease diagnosed for at least 2 years.
Patients 30 years of age or older at the time of diagnosis.
Modified Hoehn and Yahr stage of 2 to 4 at on-time.
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.

Key exclusion criteria (20 listed)

Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases
Dementia, as defined by a Mini-Mental State Exam score < 24 at screening visit
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
History of psychosis, except history of drug induced hallucinations
History of deep brain stimulation

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
Pramipexol Extended Release	Drug	Pramipexole ER
Pramipexol Immediate Release	Drug	Pramipexole IR
Placebo	Drug	Placebo

Primary outcome

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Score at Week 18
Time frame: baseline and week 18
UPDRS II+III total score on Full Analysis Set (FAS)with LOCF (Last observation carried forward), week 18 - baseline, UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms

16 secondary outcomes

Change From Baseline in Percentage Off-time at Week 18
Time frame: baseline and week 18
Change From Baseline in Percentage On-time Without Dyskinesia at Week 18
Time frame: baseline and week 18
Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18
Time frame: baseline and week 18
Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18
Time frame: baseline and week 18
Clinical Global Impression - Global Improvement (CGI-I) Responder
Time frame: after 18 weeks of treatment
Response in Patient Global Impression (PGI-I)
Time frame: after 18 weeks of treatment
Change From Baseline in UPDRS I Score After 18 Weeks
Time frame: baseline and 18 weeks
Change From Baseline in UPDRS II Score After 18 Weeks, Average at on and Off-period
Time frame: baseline and 18 weeks
Change From Baseline in UPDRS III Score After 18 Weeks
Time frame: baseline and 18 weeks
Change From Baseline in UPDRS IV Score After 18 Weeks
Time frame: baseline and 18 weeks
Change From Baseline in Beck's Depression Inventory (BDI) After 18 Weeks
Time frame: baseline and 18 weeks
Change From Baseline in Parkinson's Disease Sleep Scale (PDSS) After 18 Weeks
Time frame: baseline and 18 weeks
Change From Baseline in Parkinson's Disease Quality of Life Questionnaire 39 After 18 Weeks
Time frame: baseline and 18 weeks
Change From Baseline in European Quality of Life (EuroQol) Scale After 18 Weeks
Time frame: baseline and 18 weeks
Change From Baseline in 11-point Likert Scale for Pain Related to PD at Week 18
Time frame: baseline and week 18
Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)
Time frame: baseline and week 18

Results and safety

Results posted to the registry on 8 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pramipexole ER	165	145
Pramipexole IR	175	163
Placebo	178	157

Primary outcome: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Score at Week 18

Time frame: baseline and week 18. Least squares mean (Standard Error). Unit: Percentage of change from baseline

Measure	Pramipexole ER n = 161	Pramipexole IR n = 172	Placebo n = 174
Value	-11.0 (1.0)	-12.8 (0.9)	-6.1 (0.9)

Pramipexole ER vs Placebo: Adjusted mean difference from placebo: 4.9 (95% CI 2.4 to 7.4), p = 0.0001, ANCOVA
Pramipexole IR vs Placebo: Adjusted mean difference from placebo: 6.6 (95% CI 4.2 to 9.1), p <.0001, ANCOVA

Population analysed: Full analysis set (FAS 1) population = 507 patients FAS 1 defined as all patients who were dispensed study medication, were documented to have at least one dose of study medication, were treated for 18 weeks (or had prematurely discontinued treatment prior to week 18) and provided baseline and any on-drug post-baseline efficacy assessment

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	15 of 178 (8.4%)	74 of 178 (41.6%)	Not reported
Pramipexole ER	8 of 164 (4.9%)	73 of 164 (44.5%)	Not reported
Pramipexole IR	11 of 175 (6.3%)	90 of 175 (51.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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

76 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pramipexol Extended Release and Pramipexol Immediate Release in people with Parkinson Disease, run by Boehringer Ingelheim at 76 sites in 14 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 8 inclusion and 20 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in Italy, Philippines, South Korea, India, Russia and 9 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 8 Feb 2010). 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?

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Score at Week 18 (time frame: baseline and week 18). 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 NCT00466167.

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 8 Jul 2014; AzTrials last refreshed its copy on 6 Nov 2026.