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A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease (KW-6002)

Primary Purpose

Idiopathic Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Istradefylline 40 mg
Istradefylline 20 mg
Placebo
Sponsored by
Kyowa Hakko Kirin Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Parkinson's disease, Moderate to Severe Parkinson's Disease

Eligibility Criteria

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

Inclusion Criteria:

  • 30 years of age or older.
  • UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD
  • PD Stages 2-4 in the ON state for Modified Hoehn and Yahr Scale.
  • On levodopa therapy for at least 1 year with beneficial clinical response at the baseline visit
  • Taking at least 400mg levodopa combination daily and on stable regimen of any other anti-Parkinsonian drugs (MAO-B, COMT, DA) for at least 2 weeks prior to randomization
  • Stable dopaminergic regimen for at least 4 weeks immediately prior to randomization
  • Documented end-of-dose wearing-off and levodopa-induced dyskinesia
  • Have an average of two hours of OFF time per day

Exclusion Criteria:

  • Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion.
  • Subject who have had neurosurgical operation for PD
  • Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers
  • Subjects who smoke > 5 cigarettes/day

Sites / Locations

  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
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  • Kyowa PD Site
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  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
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  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
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  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
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  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site
  • Kyowa PD Site 1
  • Kyowa PD Site 2
  • Kyowa PD Site 4
  • Kyowa PD Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Istradefylline 20 mg/day

Istradefylline 40 mg/day

Placebo

Arm Description

Istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.

Istradefylline 40 mg and placebo to match istradefylline 20 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.

Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12
Based on the 24-hour ON/OFF patient diary data.

Secondary Outcome Measures

Total Hours of ON Time Per Day Without Troublesome Dyskinesia
Based on Patient's ON/OFF Diary
Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III);
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part III assesses the motor signs of Parkinson's Disease with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part III is 0 to 68. The lower the score, the more favorable the response.
Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II)
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part II is a self-evaluation of the activities of daily life (ADL) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part II is 0 to 52. The lower the score, the more favorable the response.
Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I)
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part I is the evaluation of mentation, behavior, and mood with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part I is 0 to 16. The lower the score, the more favorable the response.
Total UPDRS (Parts I + II + III);
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total possible score range for all parts combined is 0 to 136. The lower the score, the more favorable the response.
Patient Global Impression - Improvement (PGI-I) Scale
The "key symptom" on the PGI-I was evaluated at baseline and subsequent post-baseline visits for the subject's overall condition and the symptoms of fatigue, sleep, motivation to get things done, and each subject's key symptom. Subjects rated each on a scale of 1 to 5 for change from baseline utilizing the following scale: 1 = Moderate improvement (or greater) 2 = Mild improvement 3 = No change from baseline 4 = Mild deterioration 5 = Moderate deterioration (or greater) A lower number is a better outcome. Overall condition is presented below.
Sleep Time in Hours Per Day Based Upon 24-hour Diaries.
Percentage of Awake Time Per Day Spent in the OFF State
Percentage of ON Time Per Day Without Troublesome Dyskinesia.
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) assesses different cognitive domains, broken down as follows: Visuospatial and executive functioning: 5 points Animal Naming: 3 points Attention: 6 points Language: 3 points Abstraction: 2 points Delayed recall (short-term memory): 5 points Orientation: 6 points Scores can range from 0 to 30. A score of 26 or above is considered normal.
Beck Depression Inventory (BDI)
The Beck Depression Inventory is a 21-question test that measures the severity of depression. Subjects rated each on a scale of 0 to 3 for change from baseline utilizing the following scale: 0 = I do not feel sad 1 = I feel sad 2 = I am sad all the time and I can't snap out of it 3 = I am so sad or unhappy that I can't stand it The test is scored for each question using the above scale to determine the severity of depression. Scoring is as shown below: 0 to 9: minimal depression 10 to 18: mild depression 19 to 29: moderate depression 30 to 63: severe depression

Full Information

First Posted
October 18, 2013
Last Updated
October 28, 2020
Sponsor
Kyowa Hakko Kirin Pharma, Inc.
Collaborators
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01968031
Brief Title
A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
Acronym
KW-6002
Official Title
A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/Day as Treatment for Subjects With Moderate to Severe Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Hakko Kirin Pharma, Inc.
Collaborators
Kyowa Kirin Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinson's Disease. While on this study, participants will continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease
Keywords
Parkinson's disease, Moderate to Severe Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
613 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Istradefylline 20 mg/day
Arm Type
Experimental
Arm Description
Istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Arm Title
Istradefylline 40 mg/day
Arm Type
Experimental
Arm Description
Istradefylline 40 mg and placebo to match istradefylline 20 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Istradefylline 40 mg
Other Intervention Name(s)
KW-6002
Intervention Description
Istradefylline 40 mg and placebo
Intervention Type
Drug
Intervention Name(s)
Istradefylline 20 mg
Other Intervention Name(s)
KW-6002
Intervention Description
Istradefylline 20 mg and placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12
Description
Based on the 24-hour ON/OFF patient diary data.
Time Frame
Baseline, Week 2, Week 6, Week 10 and Week 12.
Secondary Outcome Measure Information:
Title
Total Hours of ON Time Per Day Without Troublesome Dyskinesia
Description
Based on Patient's ON/OFF Diary
Time Frame
Baseline, Week 2, Week 6, Week 10 and Week 12.
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III);
Description
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part III assesses the motor signs of Parkinson's Disease with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part III is 0 to 68. The lower the score, the more favorable the response.
Time Frame
Baseline, Week 2, Week 6, Week 10 and Week 12.
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II)
Description
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part II is a self-evaluation of the activities of daily life (ADL) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part II is 0 to 52. The lower the score, the more favorable the response.
Time Frame
Baseline, Week 2, Week 6, Week 10 and Week 12.
Title
Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I)
Description
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part I is the evaluation of mentation, behavior, and mood with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part I is 0 to 16. The lower the score, the more favorable the response.
Time Frame
Baseline, Week 2, Week 6, Week 10 and Week 12.
Title
Total UPDRS (Parts I + II + III);
Description
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total possible score range for all parts combined is 0 to 136. The lower the score, the more favorable the response.
Time Frame
Baseline, Week 2, Week 6, Week 10 and Week 12.
Title
Patient Global Impression - Improvement (PGI-I) Scale
Description
The "key symptom" on the PGI-I was evaluated at baseline and subsequent post-baseline visits for the subject's overall condition and the symptoms of fatigue, sleep, motivation to get things done, and each subject's key symptom. Subjects rated each on a scale of 1 to 5 for change from baseline utilizing the following scale: 1 = Moderate improvement (or greater) 2 = Mild improvement 3 = No change from baseline 4 = Mild deterioration 5 = Moderate deterioration (or greater) A lower number is a better outcome. Overall condition is presented below.
Time Frame
Baseline, Week 2, Week 6, Week 10, Week 12 and 30-day FU visit
Title
Sleep Time in Hours Per Day Based Upon 24-hour Diaries.
Time Frame
Baseline, Week 2, Week 6, Week 10 and Week 12.
Title
Percentage of Awake Time Per Day Spent in the OFF State
Time Frame
Baseline, Week 2, Week 6, Week 10 and Week 12.
Title
Percentage of ON Time Per Day Without Troublesome Dyskinesia.
Time Frame
Baseline, Week 2, Week 6, Week 10 and Week 12.
Title
Montreal Cognitive Assessment (MoCA)
Description
The Montreal Cognitive Assessment (MoCA) assesses different cognitive domains, broken down as follows: Visuospatial and executive functioning: 5 points Animal Naming: 3 points Attention: 6 points Language: 3 points Abstraction: 2 points Delayed recall (short-term memory): 5 points Orientation: 6 points Scores can range from 0 to 30. A score of 26 or above is considered normal.
Time Frame
Baseline and Week 12.
Title
Beck Depression Inventory (BDI)
Description
The Beck Depression Inventory is a 21-question test that measures the severity of depression. Subjects rated each on a scale of 0 to 3 for change from baseline utilizing the following scale: 0 = I do not feel sad 1 = I feel sad 2 = I am sad all the time and I can't snap out of it 3 = I am so sad or unhappy that I can't stand it The test is scored for each question using the above scale to determine the severity of depression. Scoring is as shown below: 0 to 9: minimal depression 10 to 18: mild depression 19 to 29: moderate depression 30 to 63: severe depression
Time Frame
Baseline and Week 12.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 30 years of age or older. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD PD Stages 2-4 in the ON state for Modified Hoehn and Yahr Scale. On levodopa therapy for at least 1 year with beneficial clinical response at the baseline visit Taking at least 400mg levodopa combination daily and on stable regimen of any other anti-Parkinsonian drugs (MAO-B, COMT, DA) for at least 2 weeks prior to randomization Stable dopaminergic regimen for at least 4 weeks immediately prior to randomization Documented end-of-dose wearing-off and levodopa-induced dyskinesia Have an average of two hours of OFF time per day Exclusion Criteria: Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion. Subject who have had neurosurgical operation for PD Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers Subjects who smoke > 5 cigarettes/day
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyowa Hakko Kirin Pharma, Inc.
Organizational Affiliation
Kyowa Hakko Kirin Pharma, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Kyowa PD Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Kyowa PD Site
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Kyowa PD Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Kyowa PD Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Kyowa PD Site
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Kyowa PD Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Kyowa PD Site
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Kyowa PD Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Kyowa PD Site
City
Reseda
State/Province
California
ZIP/Postal Code
91335
Country
United States
Facility Name
Kyowa PD Site
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94085
Country
United States
Facility Name
Kyowa PD Site
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Kyowa PD Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Kyowa PD Site
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Kyowa PD Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Kyowa PD Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Kyowa PD Site
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Kyowa PD Site
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
Kyowa PD Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33647
Country
United States
Facility Name
Kyowa PD Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Kyowa PD Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
29841
Country
United States
Facility Name
Kyowa PD Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Kyowa PD Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Kyowa PD Site
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Kyowa PD Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Kyowa PD Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Kyowa PD Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Kyowa PD Site
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Kyowa PD Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
Kyowa PD Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Kyowa PD Site
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Kyowa PD Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Kyowa PD Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Kyowa PD Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
Kyowa PD Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Kyowa PD Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Kyowa PD Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Kyowa PD Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Kyowa PD Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Kyowa PD Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Kyowa PD Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9036
Country
United States
Facility Name
Kyowa PD Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Kyowa PD Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
AB T2N
Country
Canada
Facility Name
Kyowa PD Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Kyowa PD Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Kyowa PD Site
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J9J 0A5
Country
Canada
Facility Name
Kyowa PD Site
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada
Facility Name
Kyowa PD Site
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Kyowa PD Site
City
Litomysl
ZIP/Postal Code
570 01
Country
Czechia
Facility Name
Kyowa PD Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Kyowa PD Site
City
Prague
ZIP/Postal Code
12 000
Country
Czechia
Facility Name
Kyowa PD Site
City
Prague
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Kyowa PD Site
City
Prague
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Kyowa PD Site
City
Beelitz-Heilstätten
ZIP/Postal Code
14547
Country
Germany
Facility Name
Kyowa PD Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Kyowa PD Site
City
Berlin
ZIP/Postal Code
13088
Country
Germany
Facility Name
Kyowa PD Site
City
Bremerhaven
ZIP/Postal Code
27574
Country
Germany
Facility Name
Kyowa PD Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Kyowa PD Site
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Kyowa PD Site
City
Haag
ZIP/Postal Code
83527
Country
Germany
Facility Name
Kyowa PD Site
City
Kassel
ZIP/Postal Code
34128
Country
Germany
Facility Name
Kyowa PD Site
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Kyowa PD Site
City
Munich
ZIP/Postal Code
80804
Country
Germany
Facility Name
Kyowa PD Site
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Kyowa PD Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Kyowa PD Site
City
Haifa
ZIP/Postal Code
39106
Country
Israel
Facility Name
Kyowa PD Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Kyowa PD Site
City
Petach Tiqva
ZIP/Postal Code
49372
Country
Israel
Facility Name
Kyowa PD Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kyowa PD Site
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Kyowa PD Site
City
Cassino
ZIP/Postal Code
03043
Country
Italy
Facility Name
Kyowa PD Site
City
Chieti
ZIP/Postal Code
66013
Country
Italy
Facility Name
Kyowa PD Site
City
Grosseto
ZIP/Postal Code
58100
Country
Italy
Facility Name
Kyowa PD Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Kyowa PD Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Kyowa PD Site
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
Kyowa PD Site
City
Rome
ZIP/Postal Code
00163
Country
Italy
Facility Name
Kyowa PD Site
City
Venezia
ZIP/Postal Code
30126
Country
Italy
Facility Name
Kyowa PD Site
City
Vicenza
ZIP/Postal Code
36057
Country
Italy
Facility Name
Kyowa PD Site
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Kyowa PD Site
City
Kielce
ZIP/Postal Code
25-103
Country
Poland
Facility Name
Kyowa PD Site
City
Krakow
ZIP/Postal Code
31-505
Country
Poland
Facility Name
Kyowa PD Site
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Kyowa PD Site
City
Poznan
ZIP/Postal Code
61-853
Country
Poland
Facility Name
Kyowa PD Site
City
Warsaw
ZIP/Postal Code
01-697
Country
Poland
Facility Name
Kyowa PD Site
City
Warsaw
ZIP/Postal Code
04-364
Country
Poland
Facility Name
Kyowa PD Site 1
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Kyowa PD Site 2
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Kyowa PD Site 4
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Kyowa PD Site
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia

12. IPD Sharing Statement

Links:
URL
https://foxtrialfinder.michaeljfox.org/trial/3633/
Description
Fox Trial Finder is a clinical trial matching tool that helps a Parkinson's patient connect with research sites. Volunteers who sign up will receive a list of trials in their area.

Learn more about this trial

A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

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