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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01470859
Recruitment Status : Completed
First Posted : November 11, 2011
Results First Posted : October 21, 2015
Last Update Posted : October 21, 2015
Boehringer Ingelheim
Information provided by (Responsible Party):
Jian Wang, Huashan Hospital

Brief 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 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.

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson's Disease Drug: pramipexole Drug: Sinemet CR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: pramipexole
0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients
Drug: pramipexole
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.
Other Name: Sifrol

Active Comparator: Levodopa
Sinemet CR CR, Controlled Release
Drug: Sinemet CR
tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year
Other Name: Sinemet CR 250' (Levodopa 200mg, and 50mg carbidopa)

Primary Outcome Measures :
  1. Longitudinal Change of Brain Network Activity [ Time Frame: twice, baseline and 1 year after baseline ]

    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.

Secondary Outcome Measures :
  1. Unified Parkinson's Disease Rating Score (UPDRS II, III) [ Time Frame: three times: baseline, 10 weeks, 1 year ]
    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.

  2. Parkinson's Disease Questionnaire (PDQ39) [ Time Frame: twice baseline and 1 year ]

    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.

  3. Hoehn&Yahr (H&Y) Staging [ Time Frame: twice baseline and 1 year ]

    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).

  4. Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI). [ Time Frame: twice, at 10 weeks(V2) and 1 year(V5) ]

    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)

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01470859

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China, Shanghai
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai, China, 200040
Sponsors and Collaborators
Huashan Hospital
Boehringer Ingelheim
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Principal Investigator: Jian Wang, MD Huashan Hospital

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Responsible Party: Jian Wang, Professor, Huashan Hospital Identifier: NCT01470859     History of Changes
Other Study ID Numbers: KY2011-283
First Posted: November 11, 2011    Key Record Dates
Results First Posted: October 21, 2015
Last Update Posted: October 21, 2015
Last Verified: September 2015

Keywords provided by Jian Wang, Huashan Hospital:
De Novo parkinson's disease
initial treatment
Parkinson's disease-related spatial covariance pattern

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents
Dopamine Agonists
Adjuvants, Immunologic
Immunologic Factors
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors