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Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

Primary Purpose

Idiopathic Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Istradefylline 20 mg or 40 mg
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:

  1. Written informed consent;
  2. Subjects who completed Study No. 6002-014 inclusive of the 30-day follow-up period;
  3. Currently taking levodopa combination (carbidopa/levodopa or benserazide/levodopa) therapy plus at least one adjunctive PD medication;
  4. Women of child-bearing potential (WOCBP) must use a reliable method of contraception and have a negative serum pregnancy test at Screening;

Exclusion Criteria:

  1. Subjects with less than 70% treatment compliance throughout their enrollment on Study No 6002-014 and or with major protocol deviations in Study No. 6002-014 (subjects who failed to meet any of the inclusion criteria, subjects who met any of the exclusion criteria or subjects who met the criteria for subject withdrawal but who were not withdrawn);
  2. Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion;
  3. Subject who have had neurosurgical operation for PD;
  4. Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers;
  5. Subjects who have had a diagnosis of cancer or evidence of continued malignancy within the past three years (with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with normal prostate-specific antigens post resection).

Sites / Locations

  • 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
  • Kwoya 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
  • Kyowa PD Site
  • Kyowa PD Site 1
  • Kyowa PD Site 4
  • Kyowa PD Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Istradefylline 20 mg or 40 mg

Arm Description

Treatment for 52 weeks

Outcomes

Primary Outcome Measures

Evaluation of the Long-term Safety and Tolerability of Oral Istradefylline (20mg or 40mg/Day [mg/d])
The number of subjects experiencing an adverse event as well as clinical laboratory tests (chemistry, haematology and urinalysis) were collected to evaluate the safety profile of istradefylline (20mg or 40mg/day [mg/d]).

Secondary Outcome Measures

Patient Global Impression - Overall Condition (Improvement by Study Visit) (ITT Analysis Set).
The number and percentage of subjects showing improvement (moderate or mild) on PGI-I scores with Istradefylline 20 mg or 40 mg. Each subjects 'key symptom' (the symptom they had most trouble with) on the PGI-I was identified and evaluated at baseline and at Week 12, 26 and 52. In addition, the subject's overall condition and symptoms of fatigue, sleep and motivation to get things done were also evaluated at week 12, 26 and 52. Subjects rated each on a scale 1 to 5 for change from baseline status 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).

Full Information

First Posted
November 13, 2015
Last Updated
January 9, 2020
Sponsor
Kyowa Hakko Kirin Pharma, Inc.
Collaborators
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02610231
Brief Title
Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
Official Title
A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
December 20, 2017 (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 Phase 3, 52-week, open-label, flexible-dose, multinational, multicenter study to evaluate the safety and tolerability of istradefylline 20 or 40 mg/d in subjects with moderate to severe PD with motor fluctuations and dyskinesia on levodopa combination (levodopa/carbidopa or levodopa/benserazide) therapy plus at least one adjunctive PD medication. Subjects who completed 12 weeks of double-blind treatment and the 30-day follow-up period in Study No. 6002-014 will undergo Screening and Baseline evaluations for eligibility for the study. Eligible subjects will be treated with istradefylline at a starting dose of 20 mg/d with an option for a dose adjustment to 40 mg/d at Week 12 based on the Investigator's judgment of each subject's response and tolerability. If deemed necessary, one unscheduled dose adjustment visit between Week 2 to Week 12 is allowed in accordance with clinical judgment of the Investigator. Subjects who had a dose adjustment to 40 mg/d can have their dose decreased to 20 mg/d by the Investigator at a second unscheduled dose adjustment visit if there are tolerability issues. The istradefylline dose should remain fixed between Week 26 to Week 52. Consultation with the Sponsor's Medical Monitor is required prior to any unscheduled dose adjustment visits. A subject may discontinue from the study at any time.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Istradefylline 20 mg or 40 mg
Arm Type
Experimental
Arm Description
Treatment for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Istradefylline 20 mg or 40 mg
Other Intervention Name(s)
KW-6002
Intervention Description
Istradefylline 20 or 40 mg
Primary Outcome Measure Information:
Title
Evaluation of the Long-term Safety and Tolerability of Oral Istradefylline (20mg or 40mg/Day [mg/d])
Description
The number of subjects experiencing an adverse event as well as clinical laboratory tests (chemistry, haematology and urinalysis) were collected to evaluate the safety profile of istradefylline (20mg or 40mg/day [mg/d]).
Time Frame
From screening through to study completion, an average of 52 weeks
Secondary Outcome Measure Information:
Title
Patient Global Impression - Overall Condition (Improvement by Study Visit) (ITT Analysis Set).
Description
The number and percentage of subjects showing improvement (moderate or mild) on PGI-I scores with Istradefylline 20 mg or 40 mg. Each subjects 'key symptom' (the symptom they had most trouble with) on the PGI-I was identified and evaluated at baseline and at Week 12, 26 and 52. In addition, the subject's overall condition and symptoms of fatigue, sleep and motivation to get things done were also evaluated at week 12, 26 and 52. Subjects rated each on a scale 1 to 5 for change from baseline status 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).
Time Frame
From baseline through to study completion at week 52, plus 30 days post last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent; Subjects who completed Study No. 6002-014 inclusive of the 30-day follow-up period; Currently taking levodopa combination (carbidopa/levodopa or benserazide/levodopa) therapy plus at least one adjunctive PD medication; Women of child-bearing potential (WOCBP) must use a reliable method of contraception and have a negative serum pregnancy test at Screening; Exclusion Criteria: Subjects with less than 70% treatment compliance throughout their enrollment on Study No 6002-014 and or with major protocol deviations in Study No. 6002-014 (subjects who failed to meet any of the inclusion criteria, subjects who met any of the exclusion criteria or subjects who met the criteria for subject withdrawal but who were not withdrawn); 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 have had a diagnosis of cancer or evidence of continued malignancy within the past three years (with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with normal prostate-specific antigens post resection).
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 Director
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
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
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
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
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
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
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
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
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
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Kyowa PD Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Kyowa PD Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Kwoya PD Site
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Kyowa PD Site
City
Litomysl
ZIP/Postal Code
570 01
Country
Czechia
Facility Name
Kyowa PD Site
City
Prague
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Kyowa PD Site
City
Praha
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Kyowa PD Site
City
Beelitz-Heilstatten
ZIP/Postal Code
14547
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
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
Munchen
ZIP/Postal Code
80804
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
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
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
Roma
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
Krakow
ZIP/Postal Code
31-505
Country
Poland
Facility Name
Kyowa PD Site
City
Lublin
ZIP/Postal Code
20-064
Country
Poland
Facility Name
Kyowa PD Site
City
Poznan
ZIP/Postal Code
61-853
Country
Poland
Facility Name
Kyowa PD Site
City
Warszawa
ZIP/Postal Code
01-697
Country
Poland
Facility Name
Kyowa PD Site
City
Warszawa
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 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

Learn more about this trial

Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

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