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Idiopathic Parkinson's DiseaseNCT01470859

The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Early Parkinson's Disease

A study testing pramipexole and Sinemet CR in people with Idiopathic Parkinson's Disease, run by Huashan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Levodopa and non-ergot dopaminergic agonists such as pramipexole are both recommended as the first-line symptomatic treatment for early untreated Parkinson's disease (PD), previous clinical trial indicated that initial pramipexole owns advantage over levodopa regarding motor complications, on the contrary, less… Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Idiopathic Parkinson's Disease
What is being tested?
pramipexole and Sinemet CR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Dec 2011to Aug 2014
Phase
Interventional
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • idiopathic Parkinson's disease meeting United Kingdom (UK) brain bank criteria
  • De Novo
  • Hoehn\&Yahr staging (H\&Y) I-II

Who cannot join

  • Atypical Parkinsonism
  • Pregnant or breast-feeding women
  • those with abnormal Liver/kidney function
  • those participating other clinical trials within 30 days before being enrolled for this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200040

Other trials in China

About this study

Official title: a Pilot Follow-up Study of Investigating the Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in Chinese Patients With Early Parkinson's Disease

Levodopa and non-ergot dopaminergic agonists such as pramipexole are both recommended as the first-line symptomatic treatment for early untreated Parkinson's disease (PD), previous clinical trial indicated that initial pramipexole owns advantage over levodopa regarding motor complications, on the contrary, less adverse effect like freezing and severe somnolence favors initial treatment of levodopa. Thus, it remains controversial that initiation of which medication will be better for those patients with early PD.

Parkinson's disease-related spatial covariance patter (PDRP) is a new biomarker which can represent the network activity of brain and severity of PD. Based on the literatures and our previous data, the investigators hypothesize that PDRP will be served as a biomarker to help us evaluate and compare the effect of levodopa or pramipexole on the progression of PD, which might be able to provide further evidence for clinicians to address the above critical issue.

Read the detailed description

CALM-PD study found that Pramipexole can reduce the occurrence of motor complication compared with Levodopa used as initiative treatment, but it still remains debatable that initiation of which medication will be better for those patients with De Novo PD.

PDRP (Parkinson's disease-related spatial covariance pattern) is a biomarker which can represent the network activity of cortico-striato-pallido-thalamocortical pathways and highly reproducible with stable network activity in individual subjects. The study published in "J Neuroscience" in 2010 showed that the abnormal PDRP antecede the appearance of motor signs by about 2 years, indicating PDRP might be a very promising biomarker for identifying PD at its early stage. Moreover, PDRP is able to represent the progression and severity of PD as well. It was reported that Levodopa can reduce the PD-related network activity, and the degree of network suppression correlates with the clinical improvement. However, there is no study currently showing the impact of pramipexole on brain PDRP network compared with levodopa as initiative treatment.

Being tested
pramipexole, Sinemet CR
Keywords
De Novo parkinson's disease, initial treatment, pramipexole, Levodopa, Parkinson's disease-related spatial covariance pattern
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

    Also called Sifrol

    tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.

  • Sinemet CRDrug

    Also called Sinemet CR 250' (Levodopa 200mg, and 50mg carbidopa)

    tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year

Study groups in NCT01470859
Study groupRoleWhat they receive
pramipexoleActive comparator0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
Receives: Drug: pramipexole
LevodopaActive comparatorSinemet CR CR， Controlled Release
Receives: Drug: Sinemet CR

What is being measured

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

  1. Longitudinal Change of Brain Network Activity

    The brain network activity is evaluated by Parkinson's disease-related spatial covariance pattern(PDRP) value (Z score).

    The change of brain network activity is calculated by the PDRP value (Z score) at V5 - the PDRP value (Z score) at V1.

    Measured: twice, baseline and 1 year after baseline

Secondary outcomes (4)

  1. Unified Parkinson's Disease Rating Score (UPDRS II, III)

    baseline (1st visit, V1), completion of dosage titration within 10 weeks after baseline (2nd visit, V2), 1 year after baseline (final visit, V5) UPDRS II score 0-52 (13 items); UPDRS III score 0-56 (14 items); The more scores,the more severe; the two scales were evaluated separately.

    Measured: three times: baseline, 10 weeks, 1 year

  2. Parkinson's Disease Questionnaire (PDQ39)

    The PDQ39 score was assessed at baseline (1st visit, V1) and 1 year after baseline (final visit, V5).

    PDQ39 score ranges from 0-156 (0-4 each item); the more score, the more severe.

    Measured: twice baseline and 1 year

  3. Hoehn&Yahr (H&Y) Staging

    The Hoehn and Yahr scale is a commonly used scale for describing how the symptoms of Parkinson's disease progress and the disease stages. Bigger numbers indicate more symptoms and disease progression. H\&Y stage range from 0-5; the greater, the more severe.

    The H\&Y stages of patients were evaluated at baseline (1st visit, V1), and 1 year after baseline (final visit, V5).

    Measured: twice baseline and 1 year

  4. Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI).

    Patients with a score <= 2 (very much or much improved in relation to baseline) are considered as clinically improved.

    The numbers of participants with clinical improvement are reported here. The completion of dosage titration within 10 weeks after baseline (visit 2) and 1 year after baseline (final visit)

    Measured: twice, at 10 weeks(V2) and 1 year(V5)

Timeline

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

  1. First posted11 Nov 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionAug 2014
  4. Study completionAug 2014

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01470859
Sponsor's protocol ID
KY2011-283
Status last verified
Sep 2015
First submitted
9 Nov 2011
Last updated
21 Oct 2015
Data monitoring committee
Yes

Publications

  • Izumi Y, Sawada H, Yamamoto N, Kume T, Katsuki H, Shimohama S, Akaike A. Novel neuroprotective mechanisms of pramipexole, an anti-Parkinson drug, against endogenous dopamine-mediated excitotoxicity. Eur J Pharmacol. 2007 Feb 28;557(2-3):132-40. doi: 10.1016/j.ejphar.2006.11.011. Epub 2006 Nov 14.

    PubMed 17161393

  • Parkinson Study Group. A randomized placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson disease and motor fluctuations: the PRESTO study. Arch Neurol. 2005 Feb;62(2):241-8. doi: 10.1001/archneur.62.2.241.

    PubMed 15710852

  • Huang C, Tang C, Feigin A, Lesser M, Ma Y, Pourfar M, Dhawan V, Eidelberg D. Changes in network activity with the progression of Parkinson's disease. Brain. 2007 Jul;130(Pt 7):1834-46. doi: 10.1093/brain/awm086. Epub 2007 Apr 30.

    PubMed 17470495

  • Ma Y, Tang C, Spetsieris PG, Dhawan V, Eidelberg D. Abnormal metabolic network activity in Parkinson's disease: test-retest reproducibility. J Cereb Blood Flow Metab. 2007 Mar;27(3):597-605. doi: 10.1038/sj.jcbfm.9600358. Epub 2006 Jun 28.

    PubMed 16804550

  • Tang CC, Poston KL, Dhawan V, Eidelberg D. Abnormalities in metabolic network activity precede the onset of motor symptoms in Parkinson's disease. J Neurosci. 2010 Jan 20;30(3):1049-56. doi: 10.1523/JNEUROSCI.4188-09.2010.

    PubMed 20089913

  • Wang J, Ma Y, Huang Z, Sun B, Guan Y, Zuo C. Modulation of metabolic brain function by bilateral subthalamic nucleus stimulation in the treatment of Parkinson's disease. J Neurol. 2010 Jan;257(1):72-8. doi: 10.1007/s00415-009-5267-3. Epub 2009 Aug 7.

    PubMed 19662326

Questions about this trial

What is this clinical trial studying?

A study testing pramipexole and Sinemet CR in people with Idiopathic Parkinson's Disease, run by Huashan Hospital at 1 site 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 3 inclusion and 4 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 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2015). 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?

Longitudinal Change of Brain Network Activity (time frame: twice, baseline and 1 year after baseline). 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 NCT01470859, which also lists 6 linked publications.

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 21 Oct 2015.

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