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Completed

NCT Number: NCT01673724

Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease

The purpose of this study is to determine whether pramipexole and bromocriptine are effective in the treatment of non-motor symptoms in Parkinson's Disease.

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Key information

Conditions

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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Ansan Hospital, Ansan, South Korea

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About this study

PRIMARY OBJECTIVE Evaluate the Improvement of Nonmotor symptom scale (NMSS) between Pramipexole and Bromocriptine for early Parkinson's disease during 24-week treatment

SECONDARY OBJECTIVE

  • Evaluate the improvement for Depression which is one of the Nonmotor symptoms
  • Evaluate the improvement of clinical symptoms between two groups
  • Evaluate the improvement of Quality of Life between two groups

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Parkinson's disease patients in accordance with UK Queensquare Brain Bank
  • modified Hoehn & Yahr stage <3
  • Dopamine agents(Levodopa, dopamine agonists) naive patients, or the patients who have discontinued the agents at least four weeks before the screening in case of using the dopamine agents are administered before.

Exclusion criteria

  • K-MMSE<24
  • History of drug-induced Parkinsonism
  • secondary parkinsonism
  • History of schizophrenia or hallucination
  • Requirement of treatment with anti-depressants due to depressive disorder
  • Pregnant and/or breeding women
  • Renal inadequacy

Treatment and study plan

Pramipexole

Drug

pramipexole

Other names: Sandoz Pramipexole

Bromocriptine

Drug

bromocriptine

Other names: Parlodel tab

Primary outcomes

  1. K-NMSS

    Time frame: 24 weeks

    Evaluate The total and each category score of K-NMSS

Secondary outcomes

  1. K-MADRS

    Time frame: 24 weeks

    Evaluate the Improvement of the depression refering to the total score of K-MADRS

  2. UPDRS I/II/III

    Time frame: 24 weeks

    Evaluate the improvement of UPDRS I/II/III

  3. K-PDQ39

    Time frame: 24 weeks

    Evaluate the improvement of Patient's QOL

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

Effect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized Study

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 28, 2012
Registry last updated
Sep 15, 2017

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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