We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01673724
First Posted: August 28, 2012
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sandoz
  Purpose
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 Intervention Phase
Parkinson's Disease Drug: pramipexole Drug: Bromocriptine Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sandoz:

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


Secondary Outcome 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


Enrollment: 121
Study Start Date: February 2012
Study Completion Date: May 23, 2016
Primary Completion Date: May 23, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pramipexole
dosage form: tablet dosage: pramipexole 0.125/0.25/0.5/1mg frequency: tid duration: 24weeks
Drug: pramipexole
pramipexole
Other Name: Sandoz Pramipexole
Active Comparator: Bromocriptine
bromocriptine dosage form: white round tablet
Drug: Bromocriptine
bromocriptine
Other Name: Parlodel tab

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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
  Contacts and Locations
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


Locations
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
Sandoz
Investigators
Principal Investigator: Seongbeom Koh, MD Korea University Guro Hospital
  More Information

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01673724     History of Changes
Other Study ID Numbers: SKL001
First Submitted: August 23, 2012
First Posted: August 28, 2012
Last Update Posted: September 15, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pramipexole
Bromocriptine
Antioxidants
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


To Top