Parkinson DiseasePhase 3NCT00577460
Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD
A Phase 3 study testing Pramipexole in people with Parkinson Disease, run by Boehringer Ingelheim at 70 sites in 14 countries.
Trial summary
The general aim of this study is to obtain long-term safety and tolerability data on pramipexole extended release (ER), in daily doses from 0.375mg to 4.5mg once daily (qd), in patients who have previously completed a pramipexole double-blind study in advanced Parkinson's disease (PD) (248.525 trial). Read more about this study
- Who is it for?
- Ages 32 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
- 391 participants
- Where
- 70 sitesin 14 countries
- Study dates
- Dec 2007to 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 32 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of the double-blind trial 248.525
- Male or female patient with advanced idiopathic Parkinson's disease (PD), with a Modified Hoehn and Yahr stage of 2 to 4 at on-time, and a concomitant treatment with standard or controlled release L-Dopa+, or a combination of L-Dopa+ and entacapone.
- Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular the patient should be able to recognise the off-time and on-time periods during waking hours and the patient (or a family member or a guardian) should be able to record them accurately in the patient diary.
- Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference of Harmonization - Good Clinical Practice (ICH-GCP) guidelines and local legislation).
Who cannot join
- Patients prematurely withdrawn from the double-blind trial 248.525
- Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases
- Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study
- History of psychosis, except history of drug induced hallucinations
- History of deep brain stimulation
- Clinically significant ECG abnormalities at baseline
Show all 19Show fewer
- Clinically significant hypotension and/or symptomatic orthostatic hypotension at baseline
- Malignant melanoma or history of previously treated malignant melanoma
- Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study
- Pregnancy or breast-feeding
- Sexually active female of childbearing potential not using a medically approved method of birth control
- Serum levels of aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase (SGOT)), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase) (SGPT)), alkaline phosphatase (AP) or bilirubin > 2 upper limit normal (ULN) at baseline
- Patients with a creatinine clearance < 50 mL/min at baseline
- Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit
- Any of the following drugs within 4 weeks prior to baseline visit: methylphenidate, cinnarizine, amphetamines
- Flunarizine within 3 months prior to baseline
- Known hypersensitivity to pramipexole or its excipients
- Drug abuse, according to investigators judgement, within 2 years prior to baseline
- Participation in investigational drug studies other than the trial 248.525, 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
Trial locations and contacts
70 sites in 14 countries.
70 sites in 14 countries
Italy8 sites
248.634.39001 Boehringer Ingelheim Investigational Site
Catania
248.634.39010 Boehringer Ingelheim Investigational Site
Catanzaro
248.634.39009 Boehringer Ingelheim Investigational Site
Chieti
248.634.39007 Boehringer Ingelheim Investigational Site
Grosseto
248.634.39002 Boehringer Ingelheim Investigational Site
Napolii
248.634.39008 Boehringer Ingelheim Investigational Site
Pisa
248.634.39005 Boehringer Ingelheim Investigational Site
Roma
248.634.39011 Boehringer Ingelheim Investigational Site
Roma
Philippines8 sites
248.634.63202 Boehringer Ingelheim Investigational Site
Cruz, Manila
248.634.63207 Boehringer Ingelheim Investigational Site
Ermita, Manila
248.634.63210 Boehringer Ingelheim Investigational Site
Makati City
248.634.63205 Boehringer Ingelheim Investigational Site
Manila
248.634.63206 Boehringer Ingelheim Investigational Site
Manila
248.634.63201 Boehringer Ingelheim Investigational Site
Pasig
248.634.63208 Boehringer Ingelheim Investigational Site
Quezon
248.634.63204 Boehringer Ingelheim Investigational Site
Quezon City
South Korea8 sites
248.634.82001 Boehringer Ingelheim Investigational Site
Gyeonggi-do
248.634.82008 Boehringer Ingelheim Investigational Site
Kyeonggi-do
248.634.82007 Boehringer Ingelheim Investigational Site
Pusan
248.634.82002 Boehringer Ingelheim Investigational Site
Seoul
248.634.82003 Boehringer Ingelheim Investigational Site
Seoul
248.634.82004 Boehringer Ingelheim Investigational Site
Seoul
248.634.82005 Boehringer Ingelheim Investigational Site
Seoul
248.634.82006 Boehringer Ingelheim Investigational Site
Seoul
India6 sites
248.634.91002 Boehringer Ingelheim Investigational Site
Chennai
248.634.91001 Boehringer Ingelheim Investigational Site
Delhi
248.634.91003 Boehringer Ingelheim Investigational Site
Hyderabad
248.634.91007 Boehringer Ingelheim Investigational Site
Indore
248.634.91005 Boehringer Ingelheim Investigational Site
Karnataka
248.634.91006 Boehringer Ingelheim Investigational Site
Pune
Russia6 sites
248.634.07001 Boehringer Ingelheim Investigational Site
Moscow
248.634.07002 Boehringer Ingelheim Investigational Site
Moscow
248.634.07003 Boehringer Ingelheim Investigational Site
Moscow
248.634.07004 Boehringer Ingelheim Investigational Site
Moscow
248.634.07007 Boehringer Ingelheim Investigational Site
Moscow
248.634.07006 Boehringer Ingelheim Investigational Site
Saint Petersburg
Spain6 sites
248.634.34001 Boehringer Ingelheim Investigational Site
Alcorcon (Madrid)
248.634.34003 Boehringer Ingelheim Investigational Site
Barcelona
248.634.34004 Boehringer Ingelheim Investigational Site
Barcelona
248.634.34005 Boehringer Ingelheim Investigational Site
Madrid
248.634.34002 Boehringer Ingelheim Investigational Site
San Cugat Del Valles (Barcelona)
248.634.34008 Boehringer Ingelheim Investigational Site
Tarrasa (Barcelona)
Ukraine6 sites
248.634.38003 Boehringer Ingelheim Investigational Site
Dnipropetrovsk
248.634.38006 Boehringer Ingelheim Investigational Site
Kharkiv
248.634.38002 Boehringer Ingelheim Investigational Site
Kiev
248.634.38004 Boehringer Ingelheim Investigational Site
Kiev
248.634.38001 Boehringer Ingelheim Investigational Site
Zaporizhzhya
248.634.38005 Boehringer Ingelheim Investigational Site
Zaporizhzhya
Czechia5 sites
248.634.42003 Boehringer Ingelheim Investigational Site
Pardubice
248.634.42001 Boehringer Ingelheim Investigational Site
Prague
248.634.42005 Boehringer Ingelheim Investigational Site
Rakovník
248.634.42002 Boehringer Ingelheim Investigational Site
Rychnov nad Kněžnou
248.634.42004 Boehringer Ingelheim Investigational Site
Valašské Meziříčí
Hungary4 sites
248.634.36005 Boehringer Ingelheim Investigational Site
Győr
248.634.36003 Boehringer Ingelheim Investigational Site
Kecskemét
248.634.36006 Boehringer Ingelheim Investigational Site
Szeged
248.634.36004 Boehringer Ingelheim Investigational Site
Veszprém
Slovakia4 sites
248.634.42104 Boehringer Ingelheim Investigational Site
Bratislava
248.634.42105 Boehringer Ingelheim Investigational Site
Bratislava
248.634.42103 Boehringer Ingelheim Investigational Site
Dubnica nad Váhom
248.634.42101 Boehringer Ingelheim Investigational Site
Trnava
Poland3 sites
248.634.48001 Boehringer Ingelheim Investigational Site
Gdansk
248.634.48003 Boehringer Ingelheim Investigational Site
Krakow
248.634.48002 Boehringer Ingelheim Investigational Site
Warsaw
Sweden3 sites
248.634.46005 Boehringer Ingelheim Investigational Site
Malmö
248.634.46002 Boehringer Ingelheim Investigational Site
Nyköping
248.634.46001 Boehringer Ingelheim Investigational Site
Stockholm
United Kingdom2 sites
248.634.44007 Boehringer Ingelheim Investigational Site
Blackburn
248.634.44003 Boehringer Ingelheim Investigational Site
Salford
About this study
Official title: Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Advanced Parkinson's Disease (PD)
The general aim of this study is to obtain long-term safety and tolerability data on pramipexole extended release (ER), in daily doses from 0.375mg to 4.5mg once daily (qd), in patients who have previously completed a pramipexole double-blind study in advanced Parkinson's disease (PD) (248.525 trial).
- Conditions
- Parkinson Disease
- Being tested
- Pramipexole, 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.
PramipexoleDrug
Pramipexole ER 0.375 -4.5 mg
PlaceboDrug
Placebo tablets identical to Pramipexole ER tablets
| Study group | Role | What they receive |
|---|---|---|
| Pramipexole | Active comparator | Patients to receive Pramipexole ER 0.375 - 4.5 mg in tablet form daily Receives: Drug: Pramipexole |
| Placebo | Placebo comparator | Patients 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 advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation.
Measured: 80 weeks
Secondary outcomes (31)
Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III
Unified Parkinson's Disease Rating Scale (UPDRS) Successfully switched means: UPDRS II+III baseline score >20 without a relative worsening of UPDRS II+III score > 15% from baseline or UPDRS II+III baseline score <=20 without an absolute worsening of UPDRS II+III score > 3 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: One week
UPDRS II+III Change From Open Label (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
Number of Participants With UPDRS II+III Response
A response means an improvement of >=20% in UPDRS II+III 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: Week 80
Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time
A patient was considered as successfully switched if he/she has converted to ER without a worsening of off time by more than 12.5% from baseline. Off-time is based on patient diary data and describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).
Measured: One week
Percentage Off Time During Waking Hours Total Score: Change From Baseline
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).
A negative change implies improvement
Measured: Baseline and week 80
Number of Participants With Response in Percentage Off Time During Waking Hours
Response means >=20% improvement relative to OL baseline in the % off-time during waking hours
Measured: 80 weeks
Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
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. A positive change implies improvement.
Measured: Baseline and week 80
Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
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. A positive change implies improvement
Measured: Baseline and week 80
Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
Percentage on-time without dyskinesia or 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. A positive change implies improvement
Measured: Baseline and week 80
Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
Percentage on-time with 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. A positive change implies improvement
Measured: Baseline and week 80
Number of Participants With Response in CGI-I
Clinical Global Impression of Improvement (CGI-I), CGI-I scores ranging from '1' (very much improved) to '7' (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 PPX ER or IR, all patients with no change to very much improved were considered as responders
Measured: 32 weeks
Number of Participants With Response in PGI-I
Patient Global Impression of Improvement (PGI-I), PGI-I scores ranging from '1' (very much better) to '7' (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 PPX ER or IR, all patients with no change to very much better were considered as responders
Measured: 32 weeks
Number of Participants With Response in PGI-I for Early Morning Off Symptoms
Patient Global Impression of Improvement (PGI-I) for early morning off symptoms, PGI-I scores ranging from '1' (very much better) to '7' (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 PPX ER or IR, all patients with no change to very much better were considered as responders
Measured: 32 weeks
UPDRS I Total Score and Change From OL Baseline at Week 80
UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood
Measured: OL baseline and week 80
UPDRS II Total Score and Change From OL Baseline at Week 80
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: OL baseline and week 80
UPDRS III Total Score and Change From OL Baseline at Week 80
UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms
Measured: OL baseline and week 80
UPDRS IV Total Score and Change From OL Baseline at Week 80
UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy
Measured: OL baseline and week 80
Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80
PFS-16 (Parkinson fatigue scale) 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
Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80
Measured: OL baseline and week 80
Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline
Measured: OL baseline and week 80
Number of Participants With Serious Adverse Events
Measured: 80 weeks
Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
Measured: OL Baseline and Week 80
Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
Measured: OL Baseline and Week 80
Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
Measured: OL Baseline and Week 80
Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
Measured: OL Baseline and Week 80
Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set
Measured: OL Baseline and Week 80
Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set
Measured: OL Baseline and Week 80
Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set
Measured: OL Baseline and Week 80
Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set
Measured: OL Baseline and Week 80
Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set
ESS Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)
Measured: OL Baseline and Week 80
Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set
The mMIDI is a semi-structured interview designed to assess impulsive control disorders. The scale was modified to focus behaviors of: pathological gambling, compulsive buying and compulsive sexual behavioral.
Measured: Baseline, 80 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startDec 2007
- 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
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577460
- Sponsor's protocol ID
- 248.634
- Other IDs
- 2007-004235-37
- Status last verified
- Apr 2014
- First submitted
- 19 Dec 2007
- Last updated
- 16 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 May 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 Advanced Parkinson's Disease (PD)
- ClinicalTrials.gov ID
- NCT00577460
- Acronym / sponsor ID
- 248.634
- Conditions
- Parkinson Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jun 2010 (actual)
- First posted
- 20 Dec 2007 (estimated)
- Results
- Posted 14 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The general aim of this study is to obtain long-term safety and tolerability data on pramipexole extended release (ER), in daily doses from 0.375mg to 4.5mg once daily (qd), in patients who have previously completed a pramipexole double-blind study in advanced Parkinson's disease (PD) (248.525 trial).
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: PramipexolePatients to receive Pramipexole ER 0.375 - 4.5 mg in tablet form daily |
| Placebo | Placebo comparator | Drug: PlaceboPatients to receive placebo tablets identical to Pramipexole ER tablets only during transfer phase |
Who may qualify
- Ages
- 32 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 248.525
- Male or female patient with advanced idiopathic Parkinson's disease (PD), with a Modified Hoehn and Yahr stage of 2 to 4 at on-time, and a concomitant treatment with standard or controlled release L-Dopa+, or a combination of L-Dopa+ and entacapone.
- Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular the patient should be able to recognise the off-time and on-time periods during waking hours and the patient (or a family member or a guardian) should be able to record them accurately in the patient diary.
- Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference of Harmonization - Good Clinical Practice (ICH-GCP) guidelines and local legislation).
Key exclusion criteria (19 listed)
- Patients prematurely withdrawn from the double-blind trial 248.525
- Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases
- Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study
- History of psychosis, except history of drug induced hallucinations
- History of deep brain stimulation
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 |
|---|---|---|
| PramipexolePramipexole ER 0.375 -4.5 mg | Drug | Pramipexole |
| PlaceboPlacebo tablets identical to Pramipexole ER tablets | Drug | Placebo |
Primary outcome
Percentage of Patients With Adverse Events, Adverse Drug Reactions, Serious Adverse Events
Time frame: 80 weeks
The aim of this study was to obtain long-term safety and tolerability data on pramipexole ER, in patients who have previously completed a pramipexole double blind study in advanced Parkinson's Disease (PD) (248.525 (NCT00466167)). Therefore these items were considered as a safety evaluation.
31 secondary outcomes
Patients Successfully Switched From Pramipexole (PPX) IR or ER to ER Assessed on UPDRS II+III
Time frame: One week
UPDRS II+III Change From Open Label (OL) Baseline
Time frame: OL Baseline and week 80
Number of Participants With UPDRS II+III Response
Time frame: Week 80
Number of Patients Successfully Switched From PPX IR or ER to ER Assessed on Off-time
Time frame: One week
Percentage Off Time During Waking Hours Total Score: Change From Baseline
Time frame: Baseline and week 80
Number of Participants With Response in Percentage Off Time During Waking Hours
Time frame: 80 weeks
Percentage on Time Without Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
Time frame: Baseline and week 80
Percentage on Time With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
Time frame: Baseline and week 80
Percentage on Time Without Dyskinesia or With Non Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
Time frame: Baseline and week 80
Percentage on Time With Troublesome Dyskinesia During Waking Hours: Change From Baseline After 80 Weeks
Time frame: Baseline and week 80
Number of Participants With Response in CGI-I
Time frame: 32 weeks
Number of Participants With Response in PGI-I
Time frame: 32 weeks
Number of Participants With Response in PGI-I for Early Morning Off Symptoms
Time frame: 32 weeks
UPDRS I Total Score and Change From OL Baseline at Week 80
Time frame: OL baseline and week 80
UPDRS II Total Score and Change From OL Baseline at Week 80
Time frame: OL baseline and week 80
UPDRS III Total Score and Change From OL Baseline at Week 80
Time frame: OL baseline and week 80
UPDRS IV Total Score and Change From OL Baseline at Week 80
Time frame: OL baseline and week 80
Parkinson Fatigue Scale (PFS-16) Score and Change From OL Baseline at Week 80
Time frame: OL baseline and week 80
Number of Participants With L-dopa Daily Dose Change: Change From OL Baseline at Week 80
Time frame: OL baseline and week 80
Number of Participants With Changes in Pramipexole Doses After 80 Weeks Compared to Pramipexole Dose at OL Baseline
Time frame: OL baseline and week 80
Number of Participants With Serious Adverse Events
Time frame: 80 weeks
Supine Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
Time frame: OL Baseline and Week 80
Standing Diastolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
Time frame: OL Baseline and Week 80
Supine Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
Time frame: OL Baseline and Week 80
Standing Systolic Blood Pressure, Baseline and Week 80, Vital Signs Treated Set
Time frame: OL Baseline and Week 80
Supine Pulse Rate, Baseline and Week 80, Vital Signs Treated Set
Time frame: OL Baseline and Week 80
Standing Pulse Rate, Baseline and Week 80, Vital Signs Treated Set
Time frame: OL Baseline and Week 80
Body Weight of Female Patients, Baseline and Week 80, Vital Signs Treated Set
Time frame: OL Baseline and Week 80
Body Weight of Male Patients, Baseline and Week 80, Vital Signs Treated Set
Time frame: OL Baseline and Week 80
Epworth Sleepiness Scale (ESS), Baseline and End of Open Label, Treated Set
Time frame: OL Baseline and Week 80
Modified Minnesota Impulsive Disorder Interview (mMIDI), Frequency of Patients With at Least One Abnormal Behavior, Treated Set
Time frame: Baseline, 80 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 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
70 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 Pramipexole in people with Parkinson Disease, run by Boehringer Ingelheim at 70 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 4 inclusion and 19 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 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 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 14 Jul 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2014; AzTrials last refreshed its copy on 7 Nov 2026.