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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Sandoz Korea
Sponsor:
Information provided by (Responsible Party):
Sandoz Korea
ClinicalTrials.gov Identifier:
NCT01673724
First received: August 23, 2012
Last updated: September 3, 2012
Last verified: September 2012
  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: 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 Korea:

Primary Outcome Measures:
  • K-NMSS [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Evaluate The total and each category score of K-NMSS


Secondary Outcome Measures:
  • K-MADRS [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Evaluate the Improvement of the depression refering to the total score of K-MADRS

  • UPDRS I/II/III [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Evaluate the improvement of UPDRS I/II/III

  • K-PDQ39 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Evaluate the improvement of Patient's QOL


Estimated Enrollment: 150
Study Start Date: February 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
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: NCT01673724

Contacts
Contact: Kim +82 2 768 9422

Locations
Korea, Republic of
Korea University Ansan Hospital Recruiting
Ansan, Korea, Republic of
Contact: na         
Inje University Busan Paik Hospital Recruiting
Busan, Korea, Republic of
Contact: na         
Youngnam University Hospital Recruiting
Daegu, Korea, Republic of
Contact: na         
Kangwon Nat'l University Hospital Recruiting
Kangwon, Korea, Republic of
Contact: na         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: na         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: na         
Inje university Sanggye Paik Hospital Recruiting
Seoul, Korea, Republic of
Contact: na         
Sponsors and Collaborators
Sandoz Korea
Investigators
Principal Investigator: Seongbeom Koh, MD Korea University Guro Hospital
  More Information

No publications provided

Responsible Party: Sandoz Korea
ClinicalTrials.gov Identifier: NCT01673724     History of Changes
Other Study ID Numbers: SKL001
Study First Received: August 23, 2012
Last Updated: September 3, 2012
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 01, 2014