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

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Jian Wang, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT01470859
First received: November 9, 2011
Last updated: August 23, 2014
Last verified: August 2014
  Purpose

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.

PDRP (Parkinson's disease-related spatial covariance pattern) 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 Intervention
Idiopathic Parkinson's Disease
Drug: pramipexole
Drug: Sinemet CR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Huashan Hospital:

Primary Outcome Measures:
  • Longitudinal change of brain network activity evaluated by Parkinson's disease-related spatial covariance pattern(PDRP) value(Z score) [ Time Frame: twice, baseline and 1 year after baseline ] [ Designated as safety issue: No ]
    baseline and 1 year after receiving pramipexole or Levodopa treatment


Secondary Outcome Measures:
  • Unified Parkinson's Disease Rating Score (II, III, and total) [ Time Frame: three times baseline, 10 weeks, 1 year ] [ Designated as safety issue: No ]
    baseline (1st visit), completion of dosage titration within 10 weeks after baseline (2nd visit), 1 year after baseline (final visit)

  • Parkinson's Disease Questionnaire (PDQ39) [ Time Frame: twice baseline and 1 year ] [ Designated as safety issue: No ]
    baseline (1st visit), and 1 year after baseline (final visit)

  • Hoehn&Yahr staging [ Time Frame: twice baseline and 1 year ] [ Designated as safety issue: No ]
    baseline (1st visit), and 1 year after baseline (final visit)

  • clinical global impression scale [ Time Frame: twice 10 weeks, and 1 year ] [ Designated as safety issue: No ]
    completion of dosage titration within 10 weeks after baseline (visit 2) and 1 year after baseline (final visit)


Enrollment: 30
Study Start Date: December 2011
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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)

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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • idiopathic Parkinson's disease meeting UK brain bank criteria
  • De Novo
  • Hoehn&Yahr staging 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470859

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

Publications:
Responsible Party: Jian Wang, Professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT01470859     History of Changes
Other Study ID Numbers: KY2011-283
Study First Received: November 9, 2011
Last Updated: August 23, 2014
Health Authority: China: Ethics Committee
China: Ministry of Health

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

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Pramipexole
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antioxidants
Protective Agents
Dopamine Agonists

ClinicalTrials.gov processed this record on October 02, 2014