Early Parkinson Disease (Early PD)Phase 3NCT00479401

Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients

A Phase 3 study testing Pramipexol Extended Release and Pramipexol Immediate Release in people with Early Parkinson Disease (Early PD), run by Boehringer Ingelheim at 95 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 30 years and older
Conditions the study is for: Early Parkinson Disease (Early PD)
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: 539 participants
Where: 95 sitesin 14 countries
Study dates: May 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 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patient with idiopathic Parkinsons disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
Parkinsons disease diagnosed within 5 years.
Patients 30 years of age or older at the time of diagnosis.
Modified Hoehn and Yahr stage of 1 to 3.
Patients requiring additional therapy/ introduction of therapy (for de novo patients) to treat their parkinsonian symptoms at the time of enrollment (screening visit, V1) according to the investigators judgement.

Who cannot join

Atypical parkinsonian syndromes due to drugs (e.g., metoclopramide, flunarizine), metabolic disorders (e.g., Wilson's disease), encephalitis or degenerative diseases (e.g., progressive supranuclear palsy).
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 (DSM-IV)
History of psychosis
Clinically significant electrocardiogram (ECG) abnormalities at screening visit
Clinically significant hypotension

Show all 20Show fewer

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
Sexually active female of childbearing potential not using a medically approved method of birth control
Serum levels of Aspartate Aminotransferase (AST) , Alanine Aminotransferase (ALT), alkaline phosphatases or bilirubin > 2 Upper Limit of Normal (ULN)
Patients with a creatinine clearance < 50 mL/min
Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit, or L-Dopa within 8 weeks prior to baseline visit.
Total cumulative duration of prior exposure to Levodopa of more than 3 months.
Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
Any of the following drugs within 4 weeks prior to the baseline visit: methylphenidate, cinnarizine, amphetamines.
Flunarizine within 3 months prior to baseline visit
Known hypersensitivity to Pramipexole or its excipients
Drug abuse (including alcohol), 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

Trial locations and contacts

95 sites in 14 countries.

Country

City, postcode or hospital

95 sites in 14 countries

United States16 sites

248.524.01014 Boehringer Ingelheim Investigational Site
Augusta, Georgia
248.524.01010 Boehringer Ingelheim Investigational Site
Boca Raton, Florida
248.524.01009 Boehringer Ingelheim Investigational Site
Burlington, Vermont
248.524.01012 Boehringer Ingelheim Investigational Site
Chicago, Illinois
248.524.01005 Boehringer Ingelheim Investigational Site
Commack, New York
248.524.01002 Boehringer Ingelheim Investigational Site
Dallas, Texas
248.524.01008 Boehringer Ingelheim Investigational Site
Danbury, Connecticut
248.524.01007 Boehringer Ingelheim Investigational Site
Elkridge, Maryland
248.524.01018 Boehringer Ingelheim Investigational Site
Gilbert, Arizona
248.524.01017 Boehringer Ingelheim Investigational Site
Hattiesburg, Mississippi
248.524.01001 Boehringer Ingelheim Investigational Site
Kansas City, Kansas
248.524.01016 Boehringer Ingelheim Investigational Site
La Jolla, California
248.524.01003 Boehringer Ingelheim Investigational Site
Midvale, Utah
248.524.01013 Boehringer Ingelheim Investigational Site
Oxnard, California
248.524.01015 Boehringer Ingelheim Investigational Site
Southfield, Michigan
248.524.01004 Boehringer Ingelheim Investigational Site
Sun City, Arizona

Other trials in United States

Japan15 sites

248.524.81010 Boehringer Ingelheim Investigational Site
Aomori, Aomori
248.524.81001 Boehringer Ingelheim Investigational Site
Bunkyo-ku, Tokyo
248.524.81005 Boehringer Ingelheim Investigational Site
Fuchu, Tokyo
248.524.81011 Boehringer Ingelheim Investigational Site
Fujisawa, Kanagawa
248.524.81013 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka
248.524.81015 Boehringer Ingelheim Investigational Site
Iwamizawa,Hokkaido
248.524.81003 Boehringer Ingelheim Investigational Site
Kodaira, Tokyo
248.524.81014 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto
248.524.81009 Boehringer Ingelheim Investigational Site
Morioka, Iwate
248.524.81008 Boehringer Ingelheim Investigational Site
Okayama, Okayama
248.524.81006 Boehringer Ingelheim Investigational Site
Ota-ku, Tokyo
248.524.81004 Boehringer Ingelheim Investigational Site
Sagamihara, Kanagawa
248.524.81007 Boehringer Ingelheim Investigational Site
Shimogyo-ku, Kyoto, Kyoto
248.524.81012 Boehringer Ingelheim Investigational Site
Shiroishi, Miyagi
248.524.81002 Boehringer Ingelheim Investigational Site
Takamatsu, Kagawa

Other trials in Japan

Germany9 sites

248.524.49002 Boehringer Ingelheim Investigational Site
Berlin
248.524.49003 Boehringer Ingelheim Investigational Site
Bochum
248.524.49011 Boehringer Ingelheim Investigational Site
Bochum
248.524.49008 Boehringer Ingelheim Investigational Site
Bremerhaven
248.524.49006 Boehringer Ingelheim Investigational Site
Dresden
248.524.49007 Boehringer Ingelheim Investigational Site
Göttingen
248.524.49001 Boehringer Ingelheim Investigational Site
Kassel
248.524.49004 Boehringer Ingelheim Investigational Site
Leipzig
248.524.49005 Boehringer Ingelheim Investigational Site
Marburg

Other trials in Germany

India9 sites

248.524.91002 Boehringer Ingelheim Investigational Site
Chennai
248.524.91009 Boehringer Ingelheim Investigational Site
Hyderabad
248.524.91010 Boehringer Ingelheim Investigational Site
Hyderabad
248.524.91001 Boehringer Ingelheim Investigational Site
Karnataka
248.524.91005 Boehringer Ingelheim Investigational Site
Maharashtra
248.524.91007 Boehringer Ingelheim Investigational Site
Maharashtra
248.524.91004 Boehringer Ingelheim Investigational Site
New Delhi
248.524.91006 Boehringer Ingelheim Investigational Site
New Delhi
248.524.91011 Boehringer Ingelheim Investigational Site
Pune

Other trials in India

Argentina8 sites

248.524.54001 Boehringer Ingelheim Investigational Site
Capital Federal
248.524.54002 Boehringer Ingelheim Investigational Site
Capital Federal
248.524.54003 Boehringer Ingelheim Investigational Site
Capital Federal
248.524.54007 Boehringer Ingelheim Investigational Site
Capital Federal
248.524.54008 Instituto de Neurociencias de Buenos Aires
Capital Federal
248.524.54009 Boehringer Ingelheim Investigational Site
Capital Federal
248.524.54006 Boehringer Ingelheim Investigational Site
Mar del Plata
248.524.54004 Boehringer Ingelheim Investigational Site
Santa Fe

Other trials in Argentina

Hungary8 sites

248.524.36007 Boehringer Ingelheim Investigational Site
Eger
248.524.36005 Boehringer Ingelheim Investigational Site
Győr
248.524.36008 Boehringer Ingelheim Investigational Site
Miskolc
248.524.36004 Boehringer Ingelheim Investigational Site
Sopron
248.524.36001 Boehringer Ingelheim Investigational Site
Szeged
248.524.36006 Boehringer Ingelheim Investigational Site
Szeged
248.524.36003 Boehringer Ingelheim Investigational Site
Szombathely
248.524.36002 Boehringer Ingelheim Investigational Site
Zalaegerszeg

Other trials in Hungary

Russia6 sites

248.524.07001 Boehringer Ingelheim Investigational Site
Moscow
248.524.07002 Boehringer Ingelheim Investigational Site
Moscow
248.524.07003 Boehringer Ingelheim Investigational Site
Moscow
248.524.07004 Boehringer Ingelheim Investigational Site
Moscow
248.524.07005 Boehringer Ingelheim Investigational Site
Saint Petersburg
248.524.07006 Boehringer Ingelheim Investigational Site
Saint Petersburg

Other trials in Russia

Ukraine6 sites

248.524.38005 Boehringer Ingelheim Investigational Site
Kiev
248.524.38001 Boehringer Ingelheim Investigational Site
Lviv
248.524.38002 Boehringer Ingelheim Investigational Site
Uzhhorod
248.524.38003 Boehringer Ingelheim Investigational Site
Vinnytzya
248.524.38004 Boehringer Ingelheim Investigational Site
Zaporizhzhya
248.524.38006 Boehringer Ingelheim Investigational Site
Zaporizhzhya

Other trials in Ukraine

Czechia4 sites

248.524.42004 Boehringer Ingelheim Investigational Site
Olomouc
248.524.42003 Boehringer Ingelheim Investigational Site
Pardubice
248.524.42001 Boehringer Ingelheim Investigational Site
Prague
248.524.42002 Boehringer Ingelheim Investigational Site
Rychnov nad Kněžnou

Other trials in Czechia

Taiwan4 sites

248.524.88603 Boehringer Ingelheim Investigational Site
Kaohsiung City
248.524.88605 Boehringer Ingelheim Investigational Site
Taichung
248.524.88601 Boehringer Ingelheim Investigational Site
Taipei
248.524.88602 Boehringer Ingelheim Investigational Site
Taoyuan

Other trials in Taiwan

Finland3 sites

248.524.35803 Boehringer Ingelheim Investigational Site
Hyvinkää
248.524.35801 Boehringer Ingelheim Investigational Site
Oulu
248.524.35802 Boehringer Ingelheim Investigational Site
Tampere

Other trials in Finland

Malaysia3 sites

248.524.60001 Boehringer Ingelheim Investigational Site
Kuala Lumpur
248.524.60004 Boehringer Ingelheim Investigational Site
Kuala Terengganu
248.524.60002 Boehringer Ingelheim Investigational Site
Pulau Pinang

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Austria2 sites

248.524.43001 Boehringer Ingelheim Investigational Site
Innsbruck
248.524.43004 Boehringer Ingelheim Investigational Site
Vienna

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Slovakia2 sites

248.524.42103 Boehringer Ingelheim Investigational Site
Dubnica nad Váhom
248.524.42101 Boehringer Ingelheim Investigational Site
Trnava

Other trials in Slovakia

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 ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-week Maintenance Phase in Patients With Early Parkinsons Disease (PD).

The objectives of this trial conducted in early Parkinson's Disease (PD) patients are to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III combined), safety, and tolerability of Pramipexole Extended Release (ER) (in daily doses from 0.375mg to 4.5mg q.d.) in comparison to placebo, and to test for non-inferiority between the two formulations (ER and IR) of pramipexole.

In addition, the efficacy of Pramipexole Immediate Release (IR) will be compared to placebo, for assay sensitivity

Conditions: Early Parkinson Disease (Early PD)
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 NCT00479401
Study group	Role	What they receive
Pramipexole Extended Release (PPX ER)	Experimental	Not described Receives: Drug: Pramipexol Extended Release
Pramipexole Immediate Release (PPX IR)	Experimental	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 Total Score
Activities of daily living are scored from 0-52 in UPDRS II, result of motor examination scored 0-108 in UPDRS III. A decrease in the score means improvement.
Measured: baseline and after 33 weeks treatment

Secondary outcomes (15)

Percentage of Responders on the Clinical Global Impressions of Improvement (CGI-I) Scale
Clinicians evaluation in a rating scale of 7 steps, 1 meaning very much improved to 7 meaning very much worse. Responders are the patients with 'much improved' and 'very much improved' on the scale
Measured: after 18 weeks of treatment compared to baseline
Percentage of Responders on the Patients Global Impressions of Improvement (PGI-I) Scale
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. Responders are the patients with 'much better' and 'very much better' on the score.
Measured: after 18 weeks of treatment compared to baseline
UPDRS II+III Responder Rate (at Least 20% Improvement)
Responders are defined as at least 20% decrease in the UPDRS II+III score. UPDRS II+III ranges 0-160 scores from best to worse.
Measured: after 33 weeks treatment
UPDRS Part I Change From Baseline
UPDRS I evaluates mentation behaviour and mood with a total score of 0-16. Decrease in the scores means improvement
Measured: baseline and after 33 weeks treatment
UPDRS Part II Total Score
UPDRS II evaluates activities of daily living in a score 0-52. Decrease of the score means improvement
Measured: after 33 weeks treatment
UPDRS Part III Total Score
UPDRS III is the result of a motor examination with the scores 0-108. A decrease in the scores means improvement
Measured: after 33 weeks treatment
Beck's Depression Inventory Version I A
The Beck's Depression Inventory (BDI) is a 21-item self-rating scale that was originally designed as an instrument to assess the intensity of depressive symptoms (sadness, pessimism, sense of failure, dissatisfaction, guilt, expectation of punishment, dislike of self, self-accusation, suicidal ideation, episodes of crying, irritability, social withdrawal, indecisiveness, changes in body image, retardation, insomnia, fatigability, loss of appetite and weight, somatic preoccupation, low level of energy). Each item is scored from 0 (absent) to 3 (severe). The patients select the score which best describes their status in the last 7 days. Since its introduction in 1961, its use has been extended (also to PD patients) and today it is used also as a screening instrument as well as an outcome measure in depression treatment trials. The total score sums the 21 individual items yielding a score that can range from zero (minimal depression) to 63 (severe depression).
Measured: after 33 weeks treatment
Likert Scale for Pain Related to PD
Patient assessed 11 units on a scale from 'no pain' to 'unbearable pain'. Decrease of the score means improvement
Measured: after 33 weeks treatment
Parkinson's Disease Sleep Scale (PDSS)
PDSS is a self-rated instrument addressing 15 commonly reported symptoms associated with sleep disturbance on 15 visual analogue scales (VAS: 0 to 10 cm) each ranging from worst score ('awful or always' at the left extremity to the best score ('excellent or never' at the right extremity) An increase in the score means improvement. Worst possible score 0, best score 150)
Measured: after 33 weeks treatment
Change From Baseline in Parkinson's Disease Quality of Life Questionnaire Total Score
The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health which patients consider to be adversely affected by the disease. Higher scores are consistently associated with more severe symptoms of the disease such as tremor and stiffness, while lower scores indicate a better perceived health status. The 8 domains include:
- mobility (e.g. fear of falling when walking): 10 items
- activities of daily living (e.g. difficulty cutting food): 6 items
- emotional well-being (e.g. feelings of isolation): 6 items
- stigma (e.g. social embarrassment): 4 items
- social support: 3 items
- cognition: 4 items
- communication: 3 items
- bodily discomfort: 3 items.
A total score is calculated by summing the responses to the 39 individual items and the total ranges from 0 (no problem at all) to 156 (maximum level of problem). A negative change in the total score indicates improvement.
Measured: after 33 weeks treatment
Change From Baseline in European Quality of Life Visual Analog Scale
European Quality of Life Visual Analog Scale (EQ-5D VAS) is a 20 centimeter vertical analog scale assessing the patient's general health status with scores ranging from 0 (worst imaginable health) to 100 (perfect health). A positive change in the scale indicates improvement in health status.
Measured: after 33 weeks treatment
Patients Who Started to Use L-Dopa Rescue Medication
L-dopa could be introduced as rescue medication based upon the clinical judgement of the investigator. descriptive on the Full Analysis Set (FAS) population
Measured: from trial start on to any time before final assessment of the patient, up to 33 weeks
Number of Patients With Treatment Emergent Abnormal Behaviour as Indicated by the Modified Minnesota Impulsive Disorders Interview (mMIDI Questionnaire)
mMIDI is a semi-structured clinical interview to assess pathological gambling (12 questions, positive screen if patient answers 'yes' to question 1 and to at least 5 of the rest of the questions), compulsive buying (9 questions from 1a to 4c, positive screen if the patient answers 'yes' to 1a, 2a, 3a, and 4a) and compulsive sexual behaviour (4 questions, positive screen if patient answers 'yes' to question 1,2,3, or 4).
Measured: from trial start on to any time before final assessment of the patient, up to 33 weeks
Possible Clinically Significant Abnormal Laboratory Parameters
The significant abnormality of values was based on standard criteria defined in appendix 16.1.10, LISTING 4 Criteria for clinically significant abnormalities based on normalized laboratory values.
Measured: baseline and after 33 weeks of treatment
Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events
Measured: baseline and after 33 weeks of treatment

Timeline

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

May 2007Nov 2008

First posted28 May 2007 (estimated)
Study startMay 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 Early Parkinson Disease (Early PD)Studies 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 539 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00479401
Sponsor's protocol ID: 248.524
Other IDs: Eudract No 2007-000073-39
Status last verified: Jun 2014
First submitted: 25 May 2007
Last updated: 17 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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All Early Parkinson Disease (Early PD) trials

Study at a glance

From the registry record, last updated by the sponsor on 17 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 ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-week Maintenance Phase in Patients With Early Parkinsons Disease (PD).
ClinicalTrials.gov ID: NCT00479401
Acronym / sponsor ID: 248.524
Conditions: Early Parkinson Disease (Early PD)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 539 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Nov 2008 (actual)
First posted: 28 May 2007 (estimated)
Results: Posted 15 Apr 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, the efficacy of Pramipexole Immediate Release (IR) will be compared to placebo, for assay sensitivity

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Pramipexole Extended Release (PPX ER)	Experimental	Drug: Pramipexol Extended Release
Pramipexole Immediate Release (PPX IR)	Experimental	Drug: Pramipexol Immediate Release
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (5 listed)

Male or female patient with idiopathic Parkinsons disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
Parkinsons disease diagnosed within 5 years.
Patients 30 years of age or older at the time of diagnosis.
Modified Hoehn and Yahr stage of 1 to 3.
Patients requiring additional therapy/ introduction of therapy (for de novo patients) to treat their parkinsonian symptoms at the time of enrollment (screening visit, V1) according to the investigators judgement.

Key exclusion criteria (20 listed)

Atypical parkinsonian syndromes due to drugs (e.g., metoclopramide, flunarizine), metabolic disorders (e.g., Wilson's disease), encephalitis or degenerative diseases (e.g., progressive supranuclear palsy).
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 (DSM-IV)
History of psychosis
Clinically significant electrocardiogram (ECG) abnormalities at screening visit

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 Extended Release (PPX ER)
Pramipexol Immediate Release	Drug	Pramipexole Immediate Release (PPX IR)
Placebo	Drug	Placebo

Primary outcome

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score
Time frame: baseline and after 33 weeks treatment
Activities of daily living are scored from 0-52 in UPDRS II, result of motor examination scored 0-108 in UPDRS III. A decrease in the score means improvement.

15 secondary outcomes

Percentage of Responders on the Clinical Global Impressions of Improvement (CGI-I) Scale
Time frame: after 18 weeks of treatment compared to baseline
Percentage of Responders on the Patients Global Impressions of Improvement (PGI-I) Scale
Time frame: after 18 weeks of treatment compared to baseline
UPDRS II+III Responder Rate (at Least 20% Improvement)
Time frame: after 33 weeks treatment
UPDRS Part I Change From Baseline
Time frame: baseline and after 33 weeks treatment
UPDRS Part II Total Score
Time frame: after 33 weeks treatment
UPDRS Part III Total Score
Time frame: after 33 weeks treatment
Beck's Depression Inventory Version I A
Time frame: after 33 weeks treatment
Likert Scale for Pain Related to PD
Time frame: after 33 weeks treatment
Parkinson's Disease Sleep Scale (PDSS)
Time frame: after 33 weeks treatment
Change From Baseline in Parkinson's Disease Quality of Life Questionnaire Total Score
Time frame: after 33 weeks treatment
Change From Baseline in European Quality of Life Visual Analog Scale
Time frame: after 33 weeks treatment
Patients Who Started to Use L-Dopa Rescue Medication
Time frame: from trial start on to any time before final assessment of the patient, up to 33 weeks
Number of Patients With Treatment Emergent Abnormal Behaviour as Indicated by the Modified Minnesota Impulsive Disorders Interview (mMIDI Questionnaire)
Time frame: from trial start on to any time before final assessment of the patient, up to 33 weeks
Possible Clinically Significant Abnormal Laboratory Parameters
Time frame: baseline and after 33 weeks of treatment
Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events
Time frame: baseline and after 33 weeks of treatment

Results and safety

Results posted to the registry on 15 Apr 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 Extended Release (PPX ER)	223	174
Pramipexole Immediate Release (PPX IR)	213	176
Placebo	103	91

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

Time frame: baseline and after 33 weeks treatment. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	Pramipexole Extended Release (PPX ER) n = 213	Pramipexole Immediate Release (PPX IR) n = 207	Placebo n = 103
Value	-8.6 (-9.9 to -7.2)	-8.8 (-10.2 to -7.4)	-3.8 (-5.9 to -1.8)

Pramipexole Extended Release (PPX ER) vs Pramipexole Immediate Release (PPX IR): Mean Difference (Final Values): -0.2 (95% CI -2.2 to 1.7), ANCOVA

Population analysed: Full Analysis Set, all randomized patients, received at least one dose of study drug and provided any post baseline efficacy assessment

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: from trial start on to any time before final assessment of the patient, up to 33 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pramipexole Extended Release (PPX ER)	16 of 223 (7.2%)	142 of 223 (63.7%)	Not reported
Pramipexole Immediate Release (PPX IR)	11 of 213 (5.2%)	133 of 213 (62.4%)	Not reported
Placebo	4 of 103 (3.9%)	44 of 103 (42.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Early Parkinson Disease (Early PD)

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AAV2-hAADC for Parkinson's Disease (PDCS-01)
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Active, not recruitingPhase 2
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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

95 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 Early Parkinson Disease (Early PD), run by Boehringer Ingelheim at 95 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 5 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 17 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 95 sites in United States, Japan, Germany, India, Argentina 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 15 Apr 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 Total Score (time frame: baseline and after 33 weeks treatment). 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 NCT00479401.

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 17 Jul 2014.