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Completed

NCT Number: NCT01470859

The Effect of Pramipexole on Metabolic Network Activity Compared With Levodopa in 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.

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Key information

Conditions

IDIOPATHIC PARKINSON'S DISEASE Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pramipexole

Drug

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 names: Sifrol

Sinemet CR

Drug

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

Other names: Sinemet CR 250' (Levodopa 200mg, and 50mg carbidopa)

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 11, 2011
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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