Long-Term Safety Study of KW-6002 (Istradefylline) in Par... | NCT00957203

Studies
Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients

NCT00957203

Sponsor

Kyowa Kirin Co., Ltd.

Status

Completed

Last Update Posted

Aug 31, 2012Estimated

Enrollment

308Actual

Phase

Phase 3

Conditions

Parkinson's Disease

Interventions

Istradefylline

Countries

Japan

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

Aug 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

Oct 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Mar 2012Actual

First Submitted Date

Aug 7, 2009

First Submission Date that Met QC Criteria

Aug 11, 2009

First Posted Date

Aug 12, 2009Estimated

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

Aug 30, 2012

Last Update Posted Date

Aug 31, 2012Estimated

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

Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are eligible to enter into this long-term study. The purpose of this study is to evaluate the safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's disease treated with levodopa.

Detailed Description

Not provided

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

308Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Istradefylline	Experimental		Drug: Istradefylline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Istradefylline	Drug	Oral istradefylline (KW-6002) 20 or 40 mg once daily	Istradefylline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events

Secondary Outcomes

Measure	Description	Time Frame
Reducing the mean total hours of awake time per day spent in the OFF state
Reducing the mean percentage of awake time per day spent in the OFF state
Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be willing and able to give written informed consent
Completion of the study 6002-009

Exclusion Criteria:

Mini-mental status examination score of 23 or less
Less than 70% of compliance in the study 6002-009
Emergency deviation in the study 6002-009
Pregnant females

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
Study Director	Kyowa Kirin Co., Ltd.	Study Director

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
C111599	istradefylline

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided