Pramipexole and Bromocriptine on Nonmotor Symptoms of Ear... | NCT01673724

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

NCT01673724

Sponsor

Sandoz

Status

Completed

Last Update Posted

Sep 15, 2017Actual

Enrollment

121Actual

Phase

Phase 4

Conditions

Parkinson's Disease

Interventions

pramipexole
Bromocriptine

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

May 23, 2016Actual

Completion Date

May 23, 2016Actual

First Submitted Date

Aug 23, 2012

First Submission Date that Met QC Criteria

Aug 23, 2012

First Posted Date

Aug 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2017

Last Update Posted Date

Sep 15, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

121Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pramipexole	Experimental	dosage form: tablet dosage: pramipexole 0.125/0.25/0.5/1mg frequency: tid duration: 24weeks	Drug: pramipexole
Bromocriptine	Active Comparator	bromocriptine dosage form: white round tablet	Drug: Bromocriptine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pramipexole	Drug	pramipexole	pramipexole	Sandoz Pramipexole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
K-NMSS	Evaluate The total and each category score of K-NMSS	24 weeks

Secondary Outcomes

Measure	Description	Time Frame
K-MADRS	Evaluate the Improvement of the depression refering to the total score of K-MADRS	24 weeks
UPDRS I/II/III	Evaluate the improvement of UPDRS I/II/III

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seongbeom Koh, MD	Korea University Guro Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Korea University Ansan Hospital		Ansan			South Korea
Inje University Busan Paik Hospital

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077487	Pramipexole
D001971	Bromocriptine

Ancestor Terms

ID	Term
D052160	Benzothiazoles
D013844	Thiazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided