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

Sandoz

Status and phase: Completed; Phase 4

Conditions: Parkinson's Disease

Treatments: Drug: pramipexole; Drug: Bromocriptine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01673724

SKL001

Details and patient eligibility

About

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.

Full 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

Enrollment: 121 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 2 patient groups

pramipexole

Experimental group

Description:

dosage form: tablet dosage: pramipexole 0.125/0.25/0.5/1mg frequency: tid duration: 24weeks

Treatment:

Drug: pramipexole

Bromocriptine

Active Comparator group

Description:

bromocriptine dosage form: white round tablet

Treatment:

Drug: Bromocriptine