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

April 23, 2024 updated by: Kyowa Kirin Co., Ltd.

A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
239

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Kyowa PD Site
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Kyowa PD Site
  • Czechia
      • Brno, Czechia, 602 00
        • Kwoya PD Site
      • Litomysl, Czechia, 570 01
        • Kyowa PD Site
      • Prague, Czechia, 120 00
        • Kyowa PD Site
      • Praha, Czechia, 140 00
        • Kyowa PD Site
  • Germany
      • Beelitz-Heilstatten, Germany, 14547
        • Kyowa PD Site
      • Bremerhaven, Germany, 27574
        • Kyowa PD Site
      • Dresden, Germany, 01307
        • Kyowa PD Site
      • Haag, Germany, 83527
        • Kyowa PD Site
      • Kassel, Germany, 34128
        • Kyowa PD Site
      • Munchen, Germany, 80804
        • Kyowa PD Site
  • Israel
      • Haifa, Israel, 39106
        • Kyowa PD Site
      • Jerusalem, Israel, 91120
        • Kyowa PD Site
      • Ramat Gan, Israel, 52621
        • Kyowa PD Site
      • Tel Aviv, Israel, 64239
        • Kyowa PD Site
  • Italy
      • Grosseto, Italy, 58100
        • Kyowa PD Site
      • Pavia, Italy, 27100
        • Kyowa PD Site
      • Pisa, Italy, 56126
        • Kyowa PD Site
      • Roma, Italy, 00133
        • Kyowa PD Site
      • Rome, Italy, 00163
        • Kyowa PD Site
      • Venezia, Italy, 30126
        • Kyowa PD Site
      • Vicenza, Italy, 36057
        • Kyowa PD Site
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Kyowa PD Site
      • Krakow, Poland, 31-505
        • Kyowa PD Site
      • Lublin, Poland, 20-064
        • Kyowa PD Site
      • Poznan, Poland, 61-853
        • Kyowa PD Site
      • Warszawa, Poland, 01-697
        • Kyowa PD Site
      • Warszawa, Poland, 04-364
        • Kyowa PD Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Kyowa PD Site 1
      • Belgrade, Serbia, 11000
        • Kyowa PD Site 4
      • Novi Sad, Serbia, 21000
        • Kyowa PD Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Kyowa PD Site
      • Sun City, Arizona, United States, 85351
        • Kyowa PD Site
      • Tucson, Arizona, United States, 85724
        • Kyowa PD Site
    • California
      • Fountain Valley, California, United States, 92708
        • Kyowa PD Site
      • Los Angeles, California, United States, 90048
        • Kyowa PD Site
      • Oxnard, California, United States, 93030
        • Kyowa PD Site
      • Torrance, California, United States, 90505
        • Kyowa PD Site
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Kyowa PD Site
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Kyowa PD Site
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Kyowa PD Site
      • Port Charlotte, Florida, United States, 33952
        • Kyowa PD Site
      • Tampa, Florida, United States, 33647
        • Kyowa PD Site
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Kyowa PD Site
      • Augusta, Georgia, United States, 29841
        • Kyowa PD Site
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Kyowa PD Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kyowa PD Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Kyowa PD Site
    • Michigan
      • West Bloomfield, Michigan, United States, 48322
        • Kyowa PD Site
    • New York
      • Albany, New York, United States, 12208
        • Kyowa PD Site
      • New York, New York, United States, 10016
        • Kyowa PD Site
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Kyowa PD Site
      • Durham, North Carolina, United States, 27705
        • Kyowa PD Site
    • Ohio
      • Toledo, Ohio, United States, 43614
        • Kyowa PD Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

26 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Istradefylline 20 mg or 40 mg
Treatment for 52 weeks
Drug: Istradefylline 20 mg or 40 mg
Istradefylline 20 or 40 mg
Other Names:
  • KW-6002

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of the Long-term Safety and Tolerability of Oral Istradefylline (20mg or 40mg/Day [mg/d])
Time Frame: From screening through to study completion, an average of 52 weeks
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]).
From screening through to study completion, an average of 52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Global Impression - Overall Condition (Improvement by Study Visit) (ITT Analysis Set).
Time Frame: From baseline through to study completion at week 52, plus 30 days post last dose
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).
From baseline through to study completion at week 52, plus 30 days post last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kyowa Kirin Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kyowa Hakko Kirin Pharma, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kyowa Hakko Kirin Pharma, Inc., Kyowa Hakko Kirin Pharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6002-018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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