Post Marketing Surveillance Study of Sifrol® in Patients... | NCT02248181

Studies
Post Marketing Surveillance Study of Sifrol® in Patients With Idiopathic Parkinson's Disease

NCT02248181

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Sep 25, 2014Estimated

Enrollment

442Actual

Phase

Not provided

Conditions

Parkinson Disease

Interventions

Pramipexole

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

Feb 2004

Primary Completion Date

Dec 2005Actual

Completion Date

Not provided

First Submitted Date

Sep 22, 2014

First Submission Date that Met QC Criteria

Sep 22, 2014

First Posted Date

Sep 25, 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 22, 2014

Last Update Posted Date

Sep 25, 2014Estimated

Description Module

Brief Summary

Study to document pramipexole dosing during monotherapy, occurrence of fluctuations and dyskinesias, dose increases after deterioration of Parkinson's disease (PD) symptoms, assessment of the reasons for add-on treatment with L-Dopa and dosing of pramipexole and L-Dopa when given concomitantly.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

442Actual

Label	Type	Description	Intervention Names
Idiopathic PD patients			Drug: Pramipexole

Name	Type	Description	Arm Group Labels	Other Names
Pramipexole	Drug		Idiopathic PD patients	Sifrol®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in dosing details of Pramipexole		up to 21 months
Occurrence and clinical course of Parkinson Disease (PD) motor symptoms		up to 21 months

Secondary Outcomes

Measure	Description	Time Frame
Assessment of Kinetic Tremor	Spiral test with at least five rotations from the centre to the edge in blinded fashion	up to 21 months
Change in dosing details of L-Dopa		up to 21 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of early stage idiopathic Parkinson's Disease
No pre-treatment with any dopaminergic treatment (de novo patients), or Pre-treatment with L-Dopa at doses of < 200 mg/d

Exclusion Criteria:

Treating physicians are asked to consider the regulation described in the Summary of Product Characteristics (SmPC) for the treatment with pramipexole

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Idiopathic PD patients recruited at office-based neurologists, psychiatrists or physicians in special neurological clinics

Sampling Method

Non-Probability Sample

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

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided