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

Parkinson's Disease Clinical Trial

Official title:

Effect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673724
• Other study ID #: SKL001
• Status: Completed
• Phase: Phase 4
• First received: August 23, 2012
• Last updated: September 14, 2017
• Start date: February 2012
• Est. completion date: May 23, 2016

Study information

• Verified date: September 2017
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: May 23, 2016
• Est. primary completion date: May 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• pramipexole
pramipexole
• Bromocriptine
bromocriptine

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	K-NMSS	Evaluate The total and each category score of K-NMSS	24 weeks
Secondary	K-MADRS	Evaluate the Improvement of the depression refering to the total score of K-MADRS	24 weeks
Secondary	UPDRS I/II/III	Evaluate the improvement of UPDRS I/II/III	24 weeks
Secondary	K-PDQ39	Evaluate the improvement of Patient's QOL	24 weeks