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

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ClinicalTrials.gov Identifier: NCT01673724
Recruitment Status : Completed
First Posted : August 28, 2012
Last Update Posted : September 15, 2017
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: pramipexole Drug: Bromocriptine Phase 4

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


  • 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized Study
Study Start Date : February 2012
Actual Primary Completion Date : May 23, 2016
Actual Study Completion Date : May 23, 2016

Arm Intervention/treatment
Experimental: pramipexole
dosage form: tablet dosage: pramipexole 0.125/0.25/0.5/1mg frequency: tid duration: 24weeks
Drug: pramipexole
Other Name: Sandoz Pramipexole

Active Comparator: Bromocriptine
bromocriptine dosage form: white round tablet
Drug: Bromocriptine
Other Name: Parlodel tab

Primary Outcome Measures :
  1. K-NMSS [ Time Frame: 24 weeks ]
    Evaluate The total and each category score of K-NMSS

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT01673724

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Korea, Republic of
Korea University Ansan Hospital
Ansan, Korea, Republic of
Inje University Busan Paik Hospital
Busan, Korea, Republic of
Youngnam University Hospital
Daegu, Korea, Republic of
Kangwon Nat'l University Hospital
Kangwon, Korea, Republic of
Inje university Sanggye Paik Hospital
Seoul, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
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Principal Investigator: Seongbeom Koh, MD Korea University Guro Hospital
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Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01673724    
Other Study ID Numbers: SKL001
First Posted: August 28, 2012    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
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
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists