Long-term Administration Study of SND 919 Tablets in Park... | NCT00274131

Studies
Long-term Administration Study of SND 919 Tablets in Parkinson's Disease

NCT00274131

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

May 21, 2012Estimated

Enrollment

170

Phase

Phase 3

Conditions

Parkinson Disease

Interventions

Pramipexole 0.125 mg tablets
Pramipexole 0.5 mg tablets

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

May 2012

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

Dec 1998

Primary Completion Date

Not provided

Completion Date

Feb 2004

First Submitted Date

Jan 9, 2006

First Submission Date that Met QC Criteria

Jan 9, 2006

First Posted Date

Jan 10, 2006Estimated

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

May 18, 2012

Last Update Posted Date

May 21, 2012Estimated

Description Module

Brief Summary

To evaluate the efficacy and safety of long-term treatment with pramipexole tablets (BI Sifrol®) in Parkinson's disease (phase III study).

Detailed Description

The efficacy and safety of long-term treatment with pramipexole (BI Sifrol®) were evaluated in Parkinson disease patients in an open-label non-controlled design. The treatment was initiated at 0.125 mg bid (after breakfast and supper).

The dose was increased stepwise with due caution regarding the symptoms and safety of each patient, up to 1.5 mg tid (after each meal). The treatment period was set at 56 weeks, followed by a stepwise dosedecreasing period (maximum 4 weeks).

Study Hypothesis:

Comparison(s):

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

170

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
UPDRS Part II (activities of daily living) total score UPDRS Part III (motor examination) total score

Secondary Outcomes

Measure	Description	Time Frame
UPDRS Part I (mentation, behaviour and mood) total score UPDRS Part IV (complications of therapy) total score UPDRS Part I-III total score UPDRS Part I-IV total score Modified Hoehn and Yahr scale score Global impression of efficacy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a diagnosis of Parkinson's disease (including juvenile parkinsonism)

(1) Patients meeting all of the following inclusion criteria

Patients of at least 20 years of age
In- or outpatients of either sex.
Patients in any stage on the modified Hoehn and Yahr severity scale

Exclusion Criteria:

Patients with psychiatric symptoms such as confusion, hallucination, delusion, excitement, delirium, and abnormal behaviour.
Patients with subjective symptoms derived from orthostatic hypotension.
Patients with hypotension (systolic blood pressure <100 mmHg)
Patients with concomitant illness such as severe cardiac, renal, and hepatic disease
Patients with a current or past history of epilepsy
Pregnant, possibly pregnant, or lactating women
Patients receiving any other investigational products or who have received any other investigational product within 6 months of the study.
Patients who judged incompetent to give consent
Others judged by the investigator or co-investigator to be ineligible as subjects.

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

Name	Affiliation	Role
Boehringer Ingelheim Study Coordinator	Nippon Boehringer Ingelheim Co., Ltd.	Study Chair

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

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

Name	Type	Description	Arm Group Labels	Other Names
Pramipexole 0.125 mg tablets	Drug
Pramipexole 0.5 mg tablets	Drug