search
Back to results

A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
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. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
  2. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale.
  3. On levodopa/dopa-decarboxylase inhibitor for at least one year.
  4. Taking at least three doses and >=300mg of levodopa per day for at least four weeks before randomization.
  5. Predictable end of dose wearing off.
  6. Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary.
  7. Have an average of two hours of OFF time on 24-hour diaries.
  8. On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization.
  9. Be at least 20 years of age.
  10. Be willing and able to give written informed consent.

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 25 or less.
  6. History of drug or alcohol abuse or dependence within the past two years.
  7. History of psychosis.
  8. Significant drug allergies.
  9. Taking anticonvulsants for seizures.
  10. History of neurological 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

1

2

3

Arm Description

20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks)

40mg KW-6002 per day (two 20 mg KW-6002 tablets orally once daily for 12 weeks)

Two placebo tablets once daily for 12 weeks

Outcomes

Primary Outcome Measures

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 Parkinson's disease (PD) treated with levodopa/dopa-decarboxylase inhibitor.

Secondary Outcome Measures

To evaluate the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean percentage of awake time per day spent in the OFF state.
To evaluate 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).
To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS).
To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).
To evaluate the safety of 20 mg/day and 40mg/day doses of istradefylline

Full Information

First Posted
April 2, 2007
Last Updated
August 28, 2012
Sponsor
Kyowa Kirin Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT00455507
Brief Title
A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
Official Title
Placebo-controlled, Double-blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 2 Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (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.
Detailed Description
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 40mg/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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
363 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks)
Arm Title
2
Arm Type
Experimental
Arm Description
40mg KW-6002 per day (two 20 mg KW-6002 tablets orally once daily for 12 weeks)
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Two placebo tablets once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Istradefylline
Other Intervention Name(s)
KW-6002
Intervention Description
Two 10 mg KW-6002 tablets orally once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Istradefylline
Other Intervention Name(s)
KW-6002
Intervention Description
Two 20 mg tablets orally once a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two placebo tablets orally once daily for 12 weeks
Primary Outcome Measure Information:
Title
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 Parkinson's disease (PD) treated with levodopa/dopa-decarboxylase inhibitor.
Time Frame
Last Visit
Secondary Outcome Measure Information:
Title
To evaluate the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean percentage of awake time per day spent in the OFF state.
Time Frame
Every Visit
Title
To evaluate 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).
Time Frame
Every Visit
Title
To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS).
Time Frame
Every Visit
Title
To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).
Time Frame
Visit 4 and Last Visit
Title
To evaluate the safety of 20 mg/day and 40mg/day doses of istradefylline
Time Frame
Every Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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/dopa-decarboxylase inhibitor for at least one year. Taking at least three doses and >=300mg of levodopa 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. Be at least 20 years of age. Be willing and able to give written informed consent. 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 25 or less. History of drug or alcohol abuse or dependence within the past two years. History of psychosis. Significant drug allergies. Taking anticonvulsants for seizures. History of neurological 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

A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

We'll reach out to this number within 24 hrs