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

Phase 4

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: pramipexole; Drug: Bromocriptine

• Registration Number: NCT01673724
• Lead Sponsor: Sandoz

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.

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

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-08-23
• Study First Posted: 2012-08-28
• Primary Completion: 2016-05-23
• Study Completion: 2016-05-23
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-14
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pramipexole	pramipexole	dosage form: tablet dosage: pramipexole 0.125/0.25/0.5/1mg frequency: tid duration: 24weeks
Bromocriptine	Bromocriptine	bromocriptine dosage form: white round tablet

Primary Outcome Measures

Name	Time	Method
K-NMSS	24 weeks	Evaluate The total and each category score of K-NMSS

Secondary Outcome Measures

Name	Time	Method
UPDRS I/II/III	24 weeks	Evaluate the improvement of UPDRS I/II/III
K-MADRS	24 weeks	Evaluate the Improvement of the depression refering to the total score of K-MADRS
K-PDQ39	24 weeks	Evaluate the improvement of Patient's QOL

Trial Locations

Locations (7)

Korea University Anam Hospital; 🇰🇷 Seoul, 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

Inje university Sanggye Paik Hospital; 🇰🇷 Seoul, Korea, Republic of

Kangwon Nat'l University Hospital; 🇰🇷 Kangwon, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of