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

Condition(s) targeted: Parkinson's Disease

Intervention: pramipexole (Drug); Bromocriptine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sandoz Korea

Official(s) and/or principal investigator(s):
Seongbeom Koh, MD, Principal Investigator, Affiliation: Korea University Guro Hospital

Overall contact:
Kim, Phone: +82 2 768 9422

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.

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: K-NMSS

Secondary outcome:

K-MADRS

UPDRS I/II/III

K-PDQ39

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

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

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

Kim, Phone: +82 2 768 9422

Korea University Ansan Hospital, Ansan, Korea, Republic of; Recruiting
na

Inje University Busan Paik Hospital, Busan, Korea, Republic of; Recruiting
na

Youngnam University Hospital, Daegu, Korea, Republic of; Recruiting
na

Kangwon Nat'l University Hospital, Kangwon, Korea, Republic of; Recruiting
na

Inje university Sanggye Paik Hospital, Seoul, Korea, Republic of; Recruiting
na

Korea University Anam Hospital, Seoul, Korea, Republic of; Recruiting
na

Korea University Guro Hospital, Seoul, Korea, Republic of; Recruiting
na

Starting date: February 2012
Last updated: September 3, 2012