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

Overview

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.

Full Title of Study: “Effect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson’s Disease: Multicenter, Open-label, Parallel, Randomized Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 23, 2016

Detailed Description

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

Interventions

  • Drug: pramipexole
    • pramipexole
  • Drug: Bromocriptine
    • bromocriptine

Arms, Groups and Cohorts

  • Experimental: pramipexole
    • dosage form: tablet dosage: pramipexole 0.125/0.25/0.5/1mg frequency: tid duration: 24weeks
  • Active Comparator: Bromocriptine
    • bromocriptine dosage form: white round tablet

Clinical Trial Outcome Measures

Primary Measures

  • K-NMSS
    • Time Frame: 24 weeks
    • Evaluate The total and each category score of K-NMSS

Secondary Measures

  • K-MADRS
    • Time Frame: 24 weeks
    • Evaluate the Improvement of the depression refering to the total score of K-MADRS
  • UPDRS I/II/III
    • Time Frame: 24 weeks
    • Evaluate the improvement of UPDRS I/II/III
  • K-PDQ39
    • Time Frame: 24 weeks
    • Evaluate the improvement of Patient’s QOL

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sandoz
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Seongbeom Koh, MD, Principal Investigator, Korea University Guro Hospital

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