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A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Istradefylline (KW-6002)
Sponsored by
Kyowa Hakko Kirin UK, Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring KW-6002 (istradefylline), Entacapone, Placebo, Parkinson's Disease, Motor Response Complications, Levodopa Therapy

Eligibility Criteria

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

Inclusion Criteria: Patients selected for this study will be at least 30 years of age and will have been diagnosed with advanced Parkinson's disease as determined by UK Parkinson's Disease Society (UKPDS) criteria and the Modified Hoehn and Yahr Scale. The patients will have been receiving levodopa treatment for at least one year, may be taking other antiparkinsonian drugs, will have an average of at least three hours OFF time as recorded in two 24-hour ON/OFF diaries, and if female, must be non-pregnant and non-nursing. Exclusion Criteria: Patients may not be enrolled if they are taking certain medications excluded by the protocol, have been treated with any investigational drug within 30 days prior to randomisation (or five half-lives if longer), have ever received istradefylline or been treated with a COMT inhibitor, are psychotic, have clinically significant illness or laboratory values at screening, have insufficient mental capacity to comply with protocol requirements or certain psychiatric or neurological conditions. -

Sites / Locations

  • Kyowa Hakko UK Ltd.

Outcomes

Primary Outcome Measures

OFF time assessed by patient diaries at endpoint.

Secondary Outcome Measures

Efficacy: OFF time
ON time
UPDRS (parts I-IVa)
PDQ-39, PCG-I, CGI-S and SF-36 scores at endpoint.
Safety: clinical laboratory tests
12-lead ECG
vital signs
physical (including neurological) examination and adverse events throughout.

Full Information

First Posted
September 12, 2005
Last Updated
July 12, 2016
Sponsor
Kyowa Hakko Kirin UK, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00199394
Brief Title
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease
Official Title
A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/Day KW-6002 (Istradefylline) and That of Entacapone Versus Placebo as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kyowa Hakko Kirin UK, Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of 40 mg a day of istradefylline (KW-6002) for reducing the percentage of awake time spent in the OFF state in patients with advanced Parkinson's disease treated with levodopa.
Detailed Description
Parkinson's disease (PD) is a progressive motor disease characterized by bradykinesia or akinesia, rigidity, and resting tremor. Levodopa is still the most widely used treatment for PD, but as the disease progresses the drug tends to become less helpful. This is because of the development of motor response complications such as end-of-dose deterioration or wearing-off, peak dose dyskinesias, and ON-OFF phenomenon. Comparison(s): The safety of 40 mg/d istradefylline and the efficacy for reducing the percentage of OFF time in patients with advanced PD treated with levodopa will be compared to placebo. The safety and efficacy of Entacapone will also be compared to placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
KW-6002 (istradefylline), Entacapone, Placebo, Parkinson's Disease, Motor Response Complications, Levodopa Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
405 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Istradefylline (KW-6002)
Primary Outcome Measure Information:
Title
OFF time assessed by patient diaries at endpoint.
Secondary Outcome Measure Information:
Title
Efficacy: OFF time
Title
ON time
Title
UPDRS (parts I-IVa)
Title
PDQ-39, PCG-I, CGI-S and SF-36 scores at endpoint.
Title
Safety: clinical laboratory tests
Title
12-lead ECG
Title
vital signs
Title
physical (including neurological) examination and adverse events throughout.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients selected for this study will be at least 30 years of age and will have been diagnosed with advanced Parkinson's disease as determined by UK Parkinson's Disease Society (UKPDS) criteria and the Modified Hoehn and Yahr Scale. The patients will have been receiving levodopa treatment for at least one year, may be taking other antiparkinsonian drugs, will have an average of at least three hours OFF time as recorded in two 24-hour ON/OFF diaries, and if female, must be non-pregnant and non-nursing. Exclusion Criteria: Patients may not be enrolled if they are taking certain medications excluded by the protocol, have been treated with any investigational drug within 30 days prior to randomisation (or five half-lives if longer), have ever received istradefylline or been treated with a COMT inhibitor, are psychotic, have clinically significant illness or laboratory values at screening, have insufficient mental capacity to comply with protocol requirements or certain psychiatric or neurological conditions. -
Facility Information:
Facility Name
Kyowa Hakko UK Ltd.
City
Slough
State/Province
Berkshire
ZIP/Postal Code
SL14 DX
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease

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