A Study of Istradefylline (KW-6002) for the Treatment of... | NCT00199355

Studies
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

NCT00199355

Sponsor

Kyowa Kirin Co., Ltd.

Status

Completed

Last Update Posted

May 23, 2014Estimated

Enrollment

Phase

Phase 2

Conditions

Parkinson's Disease

Interventions

Istradefylline (KW-6002)

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

Apr 2005

Primary Completion Date

Mar 2006Actual

Completion Date

Mar 2006Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

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 21, 2014

Last Update Posted Date

May 23, 2014Estimated

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

To establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa.

Detailed Description

To establish the efficacy of 20 mg/d and 40mg/d doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40mg/d istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Istradefylline (KW-6002)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To establish the efficacy of 20 mg/d and 40mg/d doses of istradefylline for reducing the percentage of OFF time in patients with advanced Parkinson's disease (PD) treated with levodopa/DCI.

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the efficacy of 20 mg/d and 40mg/d dose of istradefylline for reducing the total hours of OFF time.
To evaluate the change in percentage of ON time (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale.
On levodopa/DCI for at least one year, stable dose in past 4 weeks.
Currently take at least three doses of levodopa/DCI per day.
Predictable end of dose wearing off.
Able to satisfactorily complete Hauser version of a Parkinson's diary.
Have an average of 120 minutes of OFF time on two 24 hour diaries.
On a stable regimen of medications being administered within normal therapeutic limits for Parkinson's disease for at least four weeks before randomization.
Be at least 30 years of age.

Exclusion Criteria:

Neurosurgical treatment for PD.
History of psychosis.
Diagnosis of atypical Parkinsonism or secondary Parkinsonism variant.
Diagnosis of cancer within 5 years.
Diagnosis of clinically significant illness of any organ system.
Mini-mental status examination score of 25 or less.
Taking any excluded medications.
History of drug or alcohol abuse or dependence within the past two years.
History of seizures or neurological malignant syndrome.
Clinical depression.
Pregnant or lactating females.

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

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