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Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa (6002-009)

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Istradefylline
Istradefylline
Placebo
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, levodopa, end of dose wearing off, OFF time

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Be willing and able to give written informed consent
  2. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD
  3. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale
  4. On levodopa/dopa-decarboxylase inhibitor for at least one year
  5. Taking at least three doses and >=300 mg of levodopa/dopa-decarboxylase inhibitor per day for at least four weeks before randomization
  6. Predictable end of dose wearing off
  7. Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary
  8. Have an average of two hours of OFF time on 24-hour diaries
  9. On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization
  10. On a stable dose of domperidone for at least 14 days before randomization

Exclusion Criteria:

  1. Taking any excluded medications
  2. Neurosurgical treatment or Transcranial Magnetic Stimulation for PD
  3. Diagnosis of cancer within 5 years
  4. Diagnosis of clinically significant illness of any organ system
  5. Diagnosis of dementia or mini-mental status examination score of 23 or less
  6. History of drug or alcohol abuse or dependence within the past two years
  7. History of psychosis
  8. History of significant drug allergies
  9. Taking anticonvulsants for seizures
  10. History of neuroleptic malignant syndrome
  11. Pregnant or lactating females

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Istradefylline 20mg

Istradefylline 40mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Reducing the mean total hours of awake time per day spent in the OFF state

Secondary Outcome Measures

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)
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Change in the Clinical Global Impression - Improvement scale (CGI-I)
Adverse events

Full Information

First Posted
August 7, 2009
Last Updated
August 28, 2012
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00955526
Brief Title
Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
Acronym
6002-009
Official Title
Placebo-Controlled, Double-Blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state 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 40 mg/day 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, levodopa, end of dose wearing off, OFF time

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
373 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Istradefylline 20mg
Arm Type
Experimental
Arm Title
Istradefylline 40mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Istradefylline
Other Intervention Name(s)
KW-6002
Intervention Description
20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks)
Intervention Type
Drug
Intervention Name(s)
Istradefylline
Other Intervention Name(s)
KW-6002
Intervention Description
40mg KW-6002 per day (two 20 mg tablets orally once daily for 12 weeks)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two placebo tablets once daily for 12 weeks
Primary Outcome Measure Information:
Title
Reducing the mean total hours of awake time per day spent in the OFF state
Secondary Outcome Measure Information:
Title
Reducing the mean percentage of awake time per day spent in the OFF state
Title
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)
Title
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Title
Change in the Clinical Global Impression - Improvement scale (CGI-I)
Title
Adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be willing and able to give written informed consent 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/dopa-decarboxylase inhibitor for at least one year Taking at least three doses and >=300 mg of levodopa/dopa-decarboxylase inhibitor per day for at least four weeks before randomization Predictable end of dose wearing off Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary Have an average of two hours of OFF time on 24-hour diaries On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization On a stable dose of domperidone for at least 14 days before randomization Exclusion Criteria: Taking any excluded medications Neurosurgical treatment or Transcranial Magnetic Stimulation for PD Diagnosis of cancer within 5 years Diagnosis of clinically significant illness of any organ system Diagnosis of dementia or mini-mental status examination score of 23 or less History of drug or alcohol abuse or dependence within the past two years History of psychosis History of significant drug allergies Taking anticonvulsants for seizures History of neuroleptic malignant syndrome Pregnant or lactating females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Kyowa Kirin Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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