Parkinson DiseasePhase 2/3NCT00560508
A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period
A Phase 2/3 study testing Pramipexole Immediate Release and Pramipexole Extended Release in people with Parkinson Disease, run by Boehringer Ingelheim at 19 sites in Japan.
Trial summary
The objective of this trial is to investigate the safety, tolerability, trough plasma concentration, and efficacy of pramipexole ER in comparison with those of pramipexole IR administrated orally for 12 weeks in patients with PD on levodopa (L-DOPA) therapy (the double-blind period). Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Pramipexole Immediate Release and Pramipexole Extended Release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 19 sitesJapan
- Study dates
- Nov 2007to Nov 2009
- Phase
- Phase 2/3
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients with diagnosis of PD including juvenile Parkinsonism, in whom the onset began at the age of forty or younger.
- Patients with a modified Hoehn and Yahr scale of II to IV at "on" time.
- Patients who have received an individual dosage of L-DOPA (either standard L-DOPA or L-DOPA with dopa-decarboxylase inhibitor) at a stable dose for at least 4 weeks before the baseline visit (Visit 2).
- Patients who exhibit any therapeutically problematic issues or status based on L-DOPA therapy:
- wearing-off phenomena
- no on /delayed on
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- dystonia at off time
- on-off phenomena
- freezing phenomena at off time
- the sub-optimal dose of L-DOPA had been administered due to side effects (such as dyskinesia), or therapeutical strategy
Who cannot join
- Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
- Dementia, as defined by a Mini-Mental State Examination (MMSE) score <24 at screening visit.
- Any psychiatric disorder according to DSM-IV criteria that could prevent compliance or completion of the trial and/or put the patient at risk if he/she takes part in the trial.
- History of psychosis, except history of drug induced hallucinations (provided the investigator considers that participation in the trial would not represent a significant risk for the patient).
- Clinically significant ECG abnormalities at screening visit, according to investigator's judgement.
- Clinically significant hypotension or symptomatic orthostatic hypotension (i.e., clinical symptoms of orthostatic hypotension such as dizziness postural etc associated with a decline >=20 mmHg in systolic blood pressure and a decline >=10 mmHg in diastolic blood pressure, at one minute after standing compared with the previous supine systolic and diastolic blood pressure obtained after 5 minutes of quiet rest) either at screening visit or at baseline visit.
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- Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the trial.
- Pregnancy (to be excluded by serum pregnancy test at screening visit) or breast-feeding.
- Sexually active female of childbearing potential not using a medically approved method of birth control within one month before to the screening visit and throughout the trial period.
- Serum levels of AST, ALT, alkaline phosphatases or bilirubin >2 upper limits of normal .
- Patients with a creatinine clearance <50 mL/min
- Patients with a complication or signs of malignant tumours or those within 5 years after the treatment.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Japan19 sites
248.610.019 Boehringer Ingelheim Investigational Site
Akashi, Hyogo
248.610.020 Boehringer Ingelheim Investigational Site
Akita, Akita
248.610.006 Boehringer Ingelheim Investigational Site
Aomori, Aomori
248.610.017 Boehringer Ingelheim Investigational Site
Asahikawa, Hokkaido
248.610.018 Boehringer Ingelheim Investigational Site
Asahikawa, Hokkaido
248.610.001 Boehringer Ingelheim Investigational Site
Bunkyo-ku, Tokyo
248.610.014 Boehringer Ingelheim Investigational Site
Fuchu, Tokyo
248.610.011 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka
248.610.015 Boehringer Ingelheim Investigational Site
Iwamizawa,Hokkaido
248.610.003 Boehringer Ingelheim Investigational Site
Kodaira, Tokyo
248.610.008 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto
248.610.021 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto
248.610.010 Boehringer Ingelheim Investigational Site
Morioka, Iwate
248.610.005 Boehringer Ingelheim Investigational Site
Okayama, Okayama
248.610.012 Boehringer Ingelheim Investigational Site
Osaka, Osaka
248.610.004 Boehringer Ingelheim Investigational Site
Sagamihara, Kanagawa
248.610.009 Boehringer Ingelheim Investigational Site
Shimogyo-ku, Kyoto, Kyoto
248.610.007 Boehringer Ingelheim Investigational Site
Shiroishi, Miyagi
248.610.002 Boehringer Ingelheim Investigational Site
Takamatsu, Kagawa
About this study
Official title: A Double-blind, Double-dummy, Randomised, Parallel-group Study to Investigate the Safety, Tolerability, Trough Plasma Concentration, and Efficacy of Pramipexole ER Versus Pramipexole Immediate Release (IR) Administered Orally for 12 Weeks in Patients With Parkinson's Disease (PD) on L-dopa Therapy, Followed by a 52-week Open-label Long-term Treatment Period to Evaluate the Long-term Safety and Efficacy of Pramipexole ER
The objective of this trial is to investigate the safety, tolerability, trough plasma concentration, and efficacy of pramipexole ER in comparison with those of pramipexole IR administrated orally for 12 weeks in patients with PD on levodopa (L-DOPA) therapy (the double-blind period). The double-blind period will be followed by the open-label 52 week administration of pramipexole ER to evaluate the long term safety and efficacy (the open-label period).
- Conditions
- Parkinson Disease
- Being tested
- Pramipexole Immediate Release, Pramipexole Extended Release
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pramipexole Immediate ReleaseDrug
titrated as individually needed (0.25 mg - 4.5 mg daily)
Pramipexole Extended ReleaseDrug
titration as individually needed (0.375 mg -4.5 mg daily)
| Study group | Role | What they receive |
|---|---|---|
| Pramipexole Extended Release | Experimental | patient to receive a tablet containing 0.375 mg Pramipexole ER once a day plus containing 0.125 mg Pramipexole IR placebo twice a day -> a tablet containing 1.5 mg Pramipexole ER three times daily (TID) plus 0.5 mg Pramipexole IR placebo TID Receives: Drug: Pramipexole Extended Release |
| Pramipexole Immediate Release | Active comparator | patient to receive a tablet containing 0.125 mg Pramipexole IR twice a day plus containing 0.375 mg Pramipexole ER placebo once a day -> a tablet containing 0.5 mg Pramipexole IR three times daily (TID) plus 1.5 mg Pramipexole ER placebo TID Receives: Drug: Pramipexole Immediate Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experienced Adverse Events
An adverse event is defined as any untoward medical occurrence
Measured: 12 weeks
Secondary outcomes (32)
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score
UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Measured: baseline and after 12 weeks treatment
Change From Baseline in Percentage Off-time
Percentage off-time during waking hours in the last two days 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 after 12 weeks treatment
Change From Baseline in Percentage On-time Without Dyskinesia
Percentage on-time without dyskinesia during waking hours in the last two days 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 after 12 weeks treatment
Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia
Percentage on-time with non-troublesome dyskinesia during waking hours in the last two days 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 after 12 weeks treatment
Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia
Percentage on-time without dyskinesia or non-troublesome dyskinesia during waking hours in the last two days 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 after 12 weeks treatment
Change From Baseline in Percentage On-time With Troublesome Dyskinesia
Percentage on-time with troublesome dyskinesia during waking hours in the last two days 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 after 12 weeks treatment
Responder Rate For Clinical Global Impression of Improvement (CGI-I)
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: baseline and after 12 weeks treatment
Responder Rate For Patient Global Impression of Improvement (PGI-I)
PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring of 1 or 2 (at least much better)
Measured: baseline and after 12 weeks treatment
Change From Baseline in UPDRS Part I Score
UPDRS Part I ranging from 0 (normal) to 16 (severe). UPDRS Part I measures Mentation, Behavior and Mood
Measured: baseline and after 12 weeks treatment
Change From Baseline in UPDRS Part II Score
UPDRS Part 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 after 12 weeks treatment
Change From Baseline in UPDRS Part III Score
UPDRS Part III ranging from 0 (normal) to 108 (severe). UPDRS Part III measures motor symptoms
Measured: baseline and after 12 weeks treatment
Change From Baseline in UPDRS Part IV Score
UPDRS Part IV ranging from 0 (normal) to 23 (severe). UPDRS Part IV measures complications of therapy
Measured: baseline and after 12 weeks treatment
UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement)
Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse
Measured: baseline and after 12 weeks treatment
Change From Baseline in L-dopa Daily Dose
The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit.
Measured: baseline and after 12 weeks treatment
Trough Plasma Concentration at Steady State
Geometric mean (gMean) was calculated for trough plasma concentrations of pramipexole at steady state after administration of pramipexole IR 4.5mg and pramipexole ER 4.5mg.
Measured: at Visit 8 after pramipexole ER 4.5mg and IR 4.5mg treatment
Dose Proportionality of Trough Plasma Concentration at Steady State After Pramipexole ER Treatment
Dose proportionality of trough plasma concentrations at steady state is explored by using the power model that described the functional relationship between the dose and plasma concentration
Measured: from Visit 1 to Visit 8 after pramipexole ER
Change From End of Double-Blind Period in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Dose Adjustment Phase)
UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms. Least square means and standard errors presented are from ANCOVA with factors treatment and covariate baseline.
Measured: Week 12 to Week 16
Percentage of Patients With no Worsening of UPDRS Parts II+III Total Score by More Than 15% From Week 12 to Week 16 (Open-label: Dose Adjustment Phase)
Percentage of patients with no worsening of UPDRS Parts II+III Total Score by more than 15% from week 12 to week 16 (Open-label: Dose Adjustment Phase)
Measured: Week 12 to Week 16
Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)
Clinical Global Impression of Improvement (CGI-I) at week 16 compared to patient's CGI-I status at week 12. CGI-I scores ranging from '1' (very much improved) to '7' (very much worse)
Measured: Week 12 to Week 16
Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)
Patient Global Impression of Improvement (PGI-I) at week 16 compared to patient's PGI-I status at week 12. PGI-I scores ranging from '1' (very much better) to '7' (very much worse).
Measured: Week 12 to Week 16
Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Maintenance Phase)
UPDRS II+III ranging from 0 point(normal) to 160 point (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
Measured: Baseline and after 64 weeks treatment
UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) (Open-label: Maintenance Phase)
Responders are defined as at least 20% decrease in the UPDRS Parts II+III Total Score ranges 0-160 scores from best to worse
Measured: baseline and after 64 weeks treatment
Change From Baseline in Percentage Off-time (Open-label: Maintenance Phase)
Percentage off-time during waking hours in the last two days 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 after 64 weeks treatment
Change From Baseline in Percentage On-time Without Dyskinesia (Open-label: Maintenance Phase)
Percentage on-time without dyskinesia during waking hours in the last two days 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 after 64 weeks treatment
Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia (Open-label Maintenance Phase)
Percentage on-time with non-troublesome dyskinesia during waking hours in the last two days 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 after 64 weeks treatment
Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia (Open-label Maintenance Phase)
Percentage on-time without dyskinesia or non-troublesome dyskinesia during waking hours in the last two days 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 after 64 weeks treatment
Change From Baseline in Percentage On-time With Troublesome Dyskinesia (Open-label Maintenance Phase)
Percentage on-time with troublesome dyskinesia during waking hours in the last two days 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 after 64 weeks treatment
Change From Baseline in L-dopa Daily Dose (Open-label Maintenance Phase)
The L-dopa daily dose was recorded in the electronic case report form (eCRF) at each trial visit.
Measured: baseline and after 64 weeks treatment
Change From Baseline in UPDRS Part I Score (Open-label: Maintenance Phase)
UPDRS Part I ranging from 0 (normal) to 16 (severe). UPDRS Part I measures Mentation, Behavior and Mood
Measured: baseline and after 64 weeks treatment
Change From Baseline in UPDRS Part II Score (Open-label: Maintenance Phase)
UPDRS Part 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 after 64 weeks treatment
Change From Baseline in UPDRS Part III Score (Open-label: Maintenance Phase)
UPDRS Part III ranging from 0 (normal) to 108 (severe). UPDRS Part III measures motor symptoms
Measured: baseline and after 64 weeks treatment
Change From Baseline in UPDRS Part IV Score (Open-label: Maintenance Phase)
UPDRS Part IV ranging from 0 (normal) to 23 (severe). UPDRS Part IV measures complications of therapy
Measured: baseline and after 64 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionNov 2009
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 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
- NCT00560508
- Sponsor's protocol ID
- 248.610
- Status last verified
- Jul 2014
- First submitted
- 16 Nov 2007
- Last updated
- 31 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Double-dummy, Randomised, Parallel-group Study to Investigate the Safety, Tolerability, Trough Plasma Concentration, and Efficacy of Pramipexole ER Versus Pramipexole Immediate Release (IR) Administered Orally for 12 Weeks in Patients With Parkinson's Disease (PD) on L-dopa Therapy, Followed by a 52-week Open-label Long-term Treatment Period to Evaluate the Long-term Safety and Efficacy of Pramipexole ER
- ClinicalTrials.gov ID
- NCT00560508
- Acronym / sponsor ID
- 248.610
- Conditions
- Parkinson Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Nov 2009 (actual)
- First posted
- 19 Nov 2007 (estimated)
- Results
- Posted 10 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to investigate the safety, tolerability, trough plasma concentration, and efficacy of pramipexole ER in comparison with those of pramipexole IR administrated orally for 12 weeks in patients with PD on levodopa (L-DOPA) therapy (the double-blind period). The double-blind period will be followed by the open-label 52 week administration of pramipexole ER to evaluate the long term safety and efficacy (the open-label period).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pramipexole Extended Release | Experimental | Drug: Pramipexole Extended Releasepatient to receive a tablet containing 0.375 mg Pramipexole ER once a day plus containing 0.125 mg Pramipexole IR placebo twice a day -> a tablet containing 1.5 mg Pramipexole ER three times daily (TID) plus 0.5 mg Pramipexole IR placebo TID |
| Pramipexole Immediate Release | Active comparator | Drug: Pramipexole Immediate Releasepatient to receive a tablet containing 0.125 mg Pramipexole IR twice a day plus containing 0.375 mg Pramipexole ER placebo once a day -> a tablet containing 0.5 mg Pramipexole IR three times daily (TID) plus 1.5 mg Pramipexole ER placebo TID |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female patients with diagnosis of PD including juvenile Parkinsonism, in whom the onset began at the age of forty or younger.
- Patients with a modified Hoehn and Yahr scale of II to IV at "on" time.
- Patients who have received an individual dosage of L-DOPA (either standard L-DOPA or L-DOPA with dopa-decarboxylase inhibitor) at a stable dose for at least 4 weeks before the baseline visit (Visit 2).
- Patients who exhibit any therapeutically problematic issues or status based on L-DOPA therapy:
Key exclusion criteria (12 listed)
- Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
- Dementia, as defined by a Mini-Mental State Examination (MMSE) score <24 at screening visit.
- Any psychiatric disorder according to DSM-IV criteria that could prevent compliance or completion of the trial and/or put the patient at risk if he/she takes part in the trial.
- History of psychosis, except history of drug induced hallucinations (provided the investigator considers that participation in the trial would not represent a significant risk for the patient).
- Clinically significant ECG abnormalities at screening visit, according to investigator's judgement.
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 |
|---|---|---|
| Pramipexole Immediate Releasetitrated as individually needed (0.25 mg - 4.5 mg daily) | Drug | Pramipexole Immediate Release |
| Pramipexole Extended Releasetitration as individually needed (0.375 mg -4.5 mg daily) | Drug | Pramipexole Extended Release |
Primary outcome
Percentage of Participants Who Experienced Adverse Events
Time frame: 12 weeks
An adverse event is defined as any untoward medical occurrence
32 secondary outcomes
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score
Time frame: baseline and after 12 weeks treatment
Change From Baseline in Percentage Off-time
Time frame: baseline and after 12 weeks treatment
Change From Baseline in Percentage On-time Without Dyskinesia
Time frame: baseline and after 12 weeks treatment
Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia
Time frame: baseline and after 12 weeks treatment
Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia
Time frame: baseline and after 12 weeks treatment
Change From Baseline in Percentage On-time With Troublesome Dyskinesia
Time frame: baseline and after 12 weeks treatment
Responder Rate For Clinical Global Impression of Improvement (CGI-I)
Time frame: baseline and after 12 weeks treatment
Responder Rate For Patient Global Impression of Improvement (PGI-I)
Time frame: baseline and after 12 weeks treatment
Change From Baseline in UPDRS Part I Score
Time frame: baseline and after 12 weeks treatment
Change From Baseline in UPDRS Part II Score
Time frame: baseline and after 12 weeks treatment
Change From Baseline in UPDRS Part III Score
Time frame: baseline and after 12 weeks treatment
Change From Baseline in UPDRS Part IV Score
Time frame: baseline and after 12 weeks treatment
UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement)
Time frame: baseline and after 12 weeks treatment
Change From Baseline in L-dopa Daily Dose
Time frame: baseline and after 12 weeks treatment
Trough Plasma Concentration at Steady State
Time frame: at Visit 8 after pramipexole ER 4.5mg and IR 4.5mg treatment
Dose Proportionality of Trough Plasma Concentration at Steady State After Pramipexole ER Treatment
Time frame: from Visit 1 to Visit 8 after pramipexole ER
Change From End of Double-Blind Period in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Dose Adjustment Phase)
Time frame: Week 12 to Week 16
Percentage of Patients With no Worsening of UPDRS Parts II+III Total Score by More Than 15% From Week 12 to Week 16 (Open-label: Dose Adjustment Phase)
Time frame: Week 12 to Week 16
Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)
Time frame: Week 12 to Week 16
Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)
Time frame: Week 12 to Week 16
Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Maintenance Phase)
Time frame: Baseline and after 64 weeks treatment
UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) (Open-label: Maintenance Phase)
Time frame: baseline and after 64 weeks treatment
Change From Baseline in Percentage Off-time (Open-label: Maintenance Phase)
Time frame: baseline and after 64 weeks treatment
Change From Baseline in Percentage On-time Without Dyskinesia (Open-label: Maintenance Phase)
Time frame: baseline and after 64 weeks treatment
Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia (Open-label Maintenance Phase)
Time frame: baseline and after 64 weeks treatment
Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia (Open-label Maintenance Phase)
Time frame: baseline and after 64 weeks treatment
Change From Baseline in Percentage On-time With Troublesome Dyskinesia (Open-label Maintenance Phase)
Time frame: baseline and after 64 weeks treatment
Change From Baseline in L-dopa Daily Dose (Open-label Maintenance Phase)
Time frame: baseline and after 64 weeks treatment
Change From Baseline in UPDRS Part I Score (Open-label: Maintenance Phase)
Time frame: baseline and after 64 weeks treatment
Change From Baseline in UPDRS Part II Score (Open-label: Maintenance Phase)
Time frame: baseline and after 64 weeks treatment
Change From Baseline in UPDRS Part III Score (Open-label: Maintenance Phase)
Time frame: baseline and after 64 weeks treatment
Change From Baseline in UPDRS Part IV Score (Open-label: Maintenance Phase)
Time frame: baseline and after 64 weeks treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- 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
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pramipexole Immediate Release and Pramipexole Extended Release in people with Parkinson Disease, run by Boehringer Ingelheim at 19 sites in Japan.
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 10 inclusion and 12 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 31 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 19 sites in Japan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 10 Feb 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 Participants Who Experienced Adverse Events (time frame: 12 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 31 Jul 2014.