Safety, Tolerability and Efficacy of Switching From Talip... | NCT02231905

Studies
Safety, Tolerability and Efficacy of Switching From Talipexole to Pramipexole in Patients With Parkinson's Disease

NCT02231905

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Sep 4, 2014Estimated

Enrollment

29Actual

Phase

Phase 4

Conditions

Parkinson Disease

Interventions

BI-Sifrol®

Countries

Not provided

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 2014

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

Jan 2004

Primary Completion Date

Nov 2004Actual

Completion Date

Not provided

First Submitted Date

Sep 3, 2014

First Submission Date that Met QC Criteria

Sep 3, 2014

First Posted Date

Sep 4, 2014Estimated

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 3, 2014

Last Update Posted Date

Sep 4, 2014Estimated

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

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BI-Sifrol®	Experimental	Tablets were administrated after switching from prior treatment of dopamine agonist (talipexole), treatment period consisted of an ascending period and a maintenance period, total duration was 4 to 12 weeks.	Drug: BI-Sifrol®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BI-Sifrol®	Drug		BI-Sifrol®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients who prematurely discontinued due to adverse event		up to 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change of the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living)		up to 12 weeks
Change of the sum of UPDRS Part III (motor examination)		up to 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Parkinson's disease (included juvenile parkinsonism) and treated with talipexole (Domin®)
Patients who present stable symptoms and maintain the doses of talipexole and other concomitant therapy for Parkinson's disease at least last 4 weeks
Male or female patients aged 20 and over
In or out-patients
Patient's severity characterized as Stage 1 - 5 by Modified Hoehn & Yahr scale
Ability to provide written informed consent in accordance with the Good Clinical Practice (GCP), Good Post-marketing Surveillance Practice (GPMSP) and other relevant laws such as the Pharmaceutical Affairs Law

Exclusion Criteria:

History of hypersensitivity of pramipexole
Psychiatric symptoms such as confusion, hallucination, delusion, agitation, delirium and abnormal behavior
Subjective symptom derived from orthostatic hypotension
Hypotension (systolic blood pressure; 100 mmHg or less)
Complication such as clinically significant cardiac, renal and hepatic diseases
Patients who drive a car, operate a machine, work on heights or engage in other hazardous activities
Pregnant, possibly pregnant or female in lactation
Patients who are participating in other drug studies or who receive other investigational drugs within last 3 months before enrolled this study
Other than above, those who judged by the investigator or sub-investigator to be inappropriate as for the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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