Parkinson DiseasePhase 3NCT01191944
Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) Patients
A Phase 3 study testing pramipexole immediate release tablet and pramipexole extended release tablet in people with Parkinson Disease, run by Boehringer Ingelheim at 20 sites in China.
Trial summary
The objective of this trial is to evaluate non-inferiority of pramipexole Extended release to Immediate release at 18 weeks on the primary efficacy endpoint (Unified Parkinson's Disease Rating Scale II+III) in Chinese PD patients who can be concomitantly treated with Levodopa . Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- pramipexole immediate release tablet and pramipexole extended release tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 475 participants
- Where
- 20 sitesChina
- Study dates
- Aug 2010to Jan 2012
- 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 Chinese patient with idiopathic Parkinson's disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
- Parkinson's disease diagnosed for at least 2 years.
- Patients 30 years of age or older at the time of diagnosis.
- Modified Hoehn and Yahr stage of 2 to 4 at on-time.
- If a patient is treated with standard or controlled release Levodopa combined with a Dopa-Decarboxylase-inhibitor or with Levodopa combined with a Dopa-Decarboxylase-inhibitor/entacapone, the dosage should be optimised according to investigator's judgement, and stable for at least 4 weeks prior to baseline visit.
- If a patient treated with Levodopa combined with a Dopa-Decarboxylase-inhibitor has motor fluctuations, he should not have more than 6 hours of off-time every day during waking hours (documented on a patient diary completed for 2 consecutive days before baseline visit).
- Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures (in particular, after training, the patient should be able to recognise the off-time and on-time periods during waking hours and to record them accurately in the patient diary).
- Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference on Harmonisation-Good Clinical Practice guidelines and local legislation).
Who cannot join
- Medical exclusions:
- 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 [R96-2656].
- Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders (4th edition)criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study.
- History of psychosis, except history of drug induced hallucinations (provided the investigator considers that participation to the trial would not represent a significant risk for the patient).
- History of deep brain stimulation
Show all 14Show fewer
- Clinically significant electrocardiogram abnormalities at screening visit, according to investigator's judgement.
- Clinically significant hypotension (i.e. supine systolic blood pressure < 90 mmHg) and/or symptomatic orthostatic hypotension (i.e. clinical symptoms of orthostatic hypotension 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) at screening or baseline visit.
- Malignant melanoma or history of previously treated malignant melanoma.
- Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study.
- Pregnancy (to be excluded by urine pregnancy test at screening visit) or breast-feeding.
- Sexually active female of childbearing potential (less than 6 months post-menopausal and not surgically sterilised) not using a medically approved method of birth control (i.e. oral contraceptives, intrauterine device, or double-barrier) for at least one month prior to the screening visit and throughout the study period (up to the follow-up visit).
- Serum levels of Aspartate Aminotransferase, Alanine Aminotransferase , alkaline phosphatases or total bilirubin > 2 Upper Limit of Normal (on screening lab test).
- Patients with a creatinine clearance < 50 mL/min/1.73m2 (estimated by the local lab / the investigator using the Modification of Diet in Renal Disease (MDRD), and calculated on screening lab test)
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
China20 sites
248.671.86004 Boehringer Ingelheim Investigational Site
Beijing
248.671.86006 Boehringer Ingelheim Investigational Site
Beijing
248.671.86007 Boehringer Ingelheim Investigational Site
Beijing
248.671.86020 Boehringer Ingelheim Investigational Site
Beijing
248.671.86012 Boehringer Ingelheim Investigational Site
Chengdu
248.671.86013 Boehringer Ingelheim Investigational Site
Chongqing
248.671.86014 Boehringer Ingelheim Investigational Site
Chongqing
248.671.86008 Boehringer Ingelheim Investigational Site
Guangzhou
248.671.86009 Boehringer Ingelheim Investigational Site
Guangzhou
248.671.86017 Boehringer Ingelheim Investigational Site
Hangzhou
248.671.86018 Boehringer Ingelheim Investigational Site
Hangzhou
248.671.86005 Boehringer Ingelheim Investigational Site
Jinan
248.671.86002 Boehringer Ingelheim Investigational Site
Nanjing
248.671.86001 Boehringer Ingelheim Investigational Site
Shanghai
248.671.86003 Boehringer Ingelheim Investigational Site
Shanghai
248.671.86010 Boehringer Ingelheim Investigational Site
Shanghai
248.671.86011 Boehringer Ingelheim Investigational Site
Shenyang
248.671.86019 Boehringer Ingelheim Investigational Site
Suzhou
248.671.86015 Boehringer Ingelheim Investigational Site
Wuhan
248.671.86016 Boehringer Ingelheim Investigational Site
Wuhan
About this study
Official title: A Double-blind, Double-dummy, Randomised, Parallel-group Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release Versus Pramipexole Immediate Release Administered Orally for 18 Weeks in Chinese Parkinson's Disease (PD) Patients Who Can be Concomitantly Treated With Levodopa
The objective of this trial is to evaluate non-inferiority of pramipexole Extended release to Immediate release at 18 weeks on the primary efficacy endpoint (Unified Parkinson's Disease Rating Scale II+III) in Chinese PD patients who can be concomitantly treated with Levodopa .
- Conditions
- Parkinson Disease
- Being tested
- pramipexole immediate release tablet, pramipexole extended release tablet
- 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 release tabletDrug
0.375mg-4.5mg(daily dose), three times a day
pramipexole extended release tabletDrug
0.375mg-4.5mg, once a day
| Study group | Role | What they receive |
|---|---|---|
| pramipexole Extended release | Experimental | subjects will receive 0.375mg once a day to 4.5mg once a day depending on investigator's judgement Receives: Drug: pramipexole extended release tablet |
| pramipexole Immediate release | Active comparator | subjects will receive 0.125mg three times a day to 1.0mg three times a day depending on investigator's judgement Receives: Drug: pramipexole immediate release tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18
UPDRS total score ranges from 0 (best) to 160 (worst) and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.
Measured: Baseline and week 18
Secondary outcomes (18)
Change From Baseline in Percentage Off-time During Waking Hours at Week 18
Percentage off-time during waking hours 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). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.
Measured: Baseline and week 18
Change From Baseline in Duration of Off-time During Waking Hours at Week 18
Duration of off-time during waking hours based on patient diary data. Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.
Measured: Baseline and week 18
Responder in Percentage Off-time During Waking Hours at Week 18
Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Responders were defined as patients with at least a 20 percent improvement relative to baseline.
Measured: Baseline and week 18
Change From Baseline in Percentage On-time Without Dyskinesia at Week 18
Percentage on-time without Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.
Measured: Baseline and week 18
Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18
Percentage on-time with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.
Measured: Baseline and week 18
Change From Baseline in Percentage On-time Without or With Non-troublesome Dyskinesia at Week 18
Percentage on-time without or with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.
Measured: Baseline and week 18
Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18
Percentage on-time with troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as troublesome if it interfered with function or caused meaningful discomfort. Decrease in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline.
Measured: Baseline and week 18
Change From Baseline in Duration of On-time Without Dyskinesia at Week 18
Duration of on-time without Dyskinesia based on patient diary data. On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.
Measured: Baseline and week 18
Change From Baseline in Duration of On-time With Non-troublesome Dyskinesia at Week 18
Duration 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 during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.
Measured: Baseline and week 18
Change From Baseline in Duration of On-time Without or With Non-troublesome Dyskinesia at Week 18
Duration of 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 during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.
Measured: Baseline and week 18
Change From Baseline in Duration of On-time With Troublesome Dyskinesia at Week 18
Duration of on-time with troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as troublesome if it interfered with function or caused meaningful discomfort. Decrease in the duration represents an improvement. Means are adjusted for treatment, centre and baseline.
Measured: Baseline and week 18
Clinical Global Impression of Improvement (CGI-I) Responder at Week 18
CGI-I was used to assess the overall status of Parkinsons disease (PD) after interviewing the patient about the various aspects of the PD and after evaluating adverse events and concomitant treatments. Ranging from 1 point=very much improved to 7 points=very much worse. Responders were defined as patients having score 1 or 2 (at least much improved) when comparing the past week to the assessment at baseline.
Measured: 18 weeks
Patient Global Impressions of Improvement (PGI-I) Responder at Week 18
The PGI-I scale is a patient-rated instrument which was used to measure the improvement of a patients PD symptoms throughout the study. Ranging from 1 point=very much better to 7 points=very much worse. Responders were defined as patients having score 1 or 2 (at least much better) when comparing the past week to the assessment at baseline.
Measured: 18 weeks
Responder in UPDRS Parts II+III Score at Week 18
Responders were defined as patients with at least a 20 percent improvement of UPDRS II+III score relative to baseline. UPDRS II+III ranges 0-160 scores from best to worst and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108).
Measured: Baseline and week 18
Change From Baseline in UPDRS II Score Separately at Week 18
UPDRS Part II (activities of daily living) ranges from 0 to 52. Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.
Measured: Baseline and week 18
Change From Baseline in UPDRS III Score Separately at Week 18
UPDRS Part III (motor examination) ranges from 0 to 108. Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.
Measured: Baseline and week 18
Levodopa (L-Dopa) Introduction During the Study
Number of patients without concomitant L-Dopa treatment at baseline which required L-Dopa supplementation during the study.
Measured: 18 weeks
Levodopa (L-Dopa) Dose Change During the Study
Although the number of patients who began the study with concomitant L-dopa supplementation and required a change in dosage was not analysed for this study, the change from baseline in L-dopa dose is presented.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2012
- Study completionJan 2012
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 475 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
- NCT01191944
- Sponsor's protocol ID
- 248.671
- Status last verified
- Oct 2014
- First submitted
- 30 Aug 2010
- Last updated
- 31 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 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 Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release Versus Pramipexole Immediate Release Administered Orally for 18 Weeks in Chinese Parkinson's Disease (PD) Patients Who Can be Concomitantly Treated With Levodopa
- ClinicalTrials.gov ID
- NCT01191944
- Acronym / sponsor ID
- 248.671
- Conditions
- Parkinson Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 31 Aug 2010 (estimated)
- Results
- Posted 24 Jan 2013
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 evaluate non-inferiority of pramipexole Extended release to Immediate release at 18 weeks on the primary efficacy endpoint (Unified Parkinson's Disease Rating Scale II+III) in Chinese PD patients who can be concomitantly treated with Levodopa .
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 release tabletsubjects will receive 0.375mg once a day to 4.5mg once a day depending on investigator's judgement |
| pramipexole Immediate release | Active comparator | Drug: pramipexole immediate release tabletsubjects will receive 0.125mg three times a day to 1.0mg three times a day depending on investigator's judgement |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female Chinese patient with idiopathic Parkinson's disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
- Parkinson's disease diagnosed for at least 2 years.
- Patients 30 years of age or older at the time of diagnosis.
- Modified Hoehn and Yahr stage of 2 to 4 at on-time.
- If a patient is treated with standard or controlled release Levodopa combined with a Dopa-Decarboxylase-inhibitor or with Levodopa combined with a Dopa-Decarboxylase-inhibitor/entacapone, the dosage should be optimised according to investigator's judgement, and stable for at least 4 weeks prior to baseline visit.
Key exclusion criteria (14 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 [R96-2656].
- Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders (4th edition)criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study.
- History of psychosis, except history of drug induced hallucinations (provided the investigator considers that participation to the trial would not represent a significant risk for the patient).
- 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 |
|---|---|---|
| pramipexole immediate release tablet0.375mg-4.5mg(daily dose), three times a day | Drug | pramipexole Immediate release |
| pramipexole extended release tablet0.375mg-4.5mg, once a day | Drug | pramipexole Extended release |
Primary outcome
Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18
Time frame: Baseline and week 18
UPDRS total score ranges from 0 (best) to 160 (worst) and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline.
18 secondary outcomes
Change From Baseline in Percentage Off-time During Waking Hours at Week 18
Time frame: Baseline and week 18
Change From Baseline in Duration of Off-time During Waking Hours at Week 18
Time frame: Baseline and week 18
Responder in Percentage Off-time During Waking Hours at Week 18
Time frame: Baseline and week 18
Change From Baseline in Percentage On-time Without Dyskinesia at Week 18
Time frame: Baseline and week 18
Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18
Time frame: Baseline and week 18
Change From Baseline in Percentage On-time Without or With Non-troublesome Dyskinesia at Week 18
Time frame: Baseline and week 18
Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18
Time frame: Baseline and week 18
Change From Baseline in Duration of On-time Without Dyskinesia at Week 18
Time frame: Baseline and week 18
Change From Baseline in Duration of On-time With Non-troublesome Dyskinesia at Week 18
Time frame: Baseline and week 18
Change From Baseline in Duration of On-time Without or With Non-troublesome Dyskinesia at Week 18
Time frame: Baseline and week 18
Change From Baseline in Duration of On-time With Troublesome Dyskinesia at Week 18
Time frame: Baseline and week 18
Clinical Global Impression of Improvement (CGI-I) Responder at Week 18
Time frame: 18 weeks
Patient Global Impressions of Improvement (PGI-I) Responder at Week 18
Time frame: 18 weeks
Responder in UPDRS Parts II+III Score at Week 18
Time frame: Baseline and week 18
Change From Baseline in UPDRS II Score Separately at Week 18
Time frame: Baseline and week 18
Change From Baseline in UPDRS III Score Separately at Week 18
Time frame: Baseline and week 18
Levodopa (L-Dopa) Introduction During the Study
Time frame: 18 weeks
Levodopa (L-Dopa) Dose Change During the Study
Time frame: 18 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pramipexole immediate release tablet and pramipexole extended release tablet in people with Parkinson Disease, run by Boehringer Ingelheim at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 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 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. 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 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 24 Jan 2013). 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 Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18 (time frame: Baseline and week 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2014; AzTrials last refreshed its copy on 1 Nov 2026.