Idiopathic Parkinson's DiseasePhase 3NCT02610231
Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
A Phase 3 study testing Istradefylline 20 mg or 40 mg in people with Idiopathic Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 55 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- Istradefylline 20 mg or 40 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 55 sitesin 8 countries
- Study dates
- Dec 2015to 20 Dec 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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subjects who met any of the exclusion criteria or subjects who met the criteria for subject withdrawal but who were not withdrawn);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).
Trial locations and contacts
55 sites in 8 countries.
55 sites in 8 countries
United States23 sites
Kyowa PD Site
Albany, New York, 12208
Kyowa PD Site
Asheville, North Carolina, 28806
Kyowa PD Site
Atlanta, Georgia, 30329
Kyowa PD Site
Augusta, Georgia, 29841
Kyowa PD Site
Boca Raton, Florida, 33486
Kyowa PD Site
Boston, Massachusetts, 02215
Kyowa PD Site
Danbury, Connecticut, 06810
Kyowa PD Site
Des Moines, Iowa, 50309
Kyowa PD Site
Durham, North Carolina, 27705
Kyowa PD Site
Englewood, Colorado, 80113
Kyowa PD Site
Fountain Valley, California, 92708
Kyowa PD Site
Kansas City, Kansas, 66160
Kyowa PD Site
Los Angeles, California, 90048
Kyowa PD Site
New York, New York, 10016
Kyowa PD Site
Oxnard, California, 93030
Kyowa PD Site
Phoenix, Arizona, 85004
Kyowa PD Site
Port Charlotte, Florida, 33952
Kyowa PD Site
Sun City, Arizona, 85351
Kyowa PD Site
Tampa, Florida, 33647
Kyowa PD Site
Toledo, Ohio, 43614
Kyowa PD Site
Torrance, California, 90505
Kyowa PD Site
Tucson, Arizona, 85724
Kyowa PD Site
West Bloomfield, Michigan, 48322
Italy7 sites
Kyowa PD Site
Grosseto, 58100
Kyowa PD Site
Pavia, 27100
Kyowa PD Site
Pisa, 56126
Kyowa PD Site
Roma, 00133
Kyowa PD Site
Rome, 00163
Kyowa PD Site
Venezia, 30126
Kyowa PD Site
Vicenza, 36057
Germany6 sites
Kyowa PD Site
Beelitz-Heilstätten, 14547
Kyowa PD Site
Bremerhaven, 27574
Kyowa PD Site
Dresden, 01307
Kyowa PD Site
Haag, 83527
Kyowa PD Site
Kassel, 34128
Kyowa PD Site
München, 80804
Poland6 sites
Kyowa PD Site
Bydgoszcz, 85-796
Kyowa PD Site
Krakow, 31-505
Kyowa PD Site
Lublin, 20-064
Kyowa PD Site
Poznan, 61-853
Kyowa PD Site
Warsaw, 01-697
Kyowa PD Site
Warsaw, 04-364
Czechia4 sites
Kwoya PD Site
Brno, 602 00
Kyowa PD Site
Litomyšl, 570 01
Kyowa PD Site
Prague, 120 00
Kyowa PD Site
Prague, 140 00
Israel4 sites
Kyowa PD Site
Haifa, 39106
Kyowa PD Site
Jerusalem, 91120
Kyowa PD Site
Ramat Gan, 52621
Kyowa PD Site
Tel Aviv, 64239
Serbia3 sites
Kyowa PD Site 1
Belgrade, 11000
Kyowa PD Site 4
Belgrade, 11000
Kyowa PD Site
Novi Sad, 21000
Canada2 sites
Kyowa PD Site
Calgary, Alberta, T2N 4Z6
Kyowa PD Site
Toronto, Ontario, M5T 2S8
About this study
Official title: 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.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- Istradefylline 20 mg or 40 mg
- Keywords
- Parkinson's disease, Moderate to Severe Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Istradefylline 20 mg or 40 mgDrug
Also called KW-6002
Istradefylline 20 or 40 mg
| Study group | Role | What they receive |
|---|---|---|
| Istradefylline 20 mg or 40 mg | Experimental | Treatment for 52 weeks Receives: Drug: Istradefylline 20 mg or 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]).
Measured: From screening through to study completion, an average of 52 weeks
Secondary outcomes (1)
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).
Measured: From baseline through to study completion at week 52, plus 30 days post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startDec 2015
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin Pharma, Inc.
- Responsible party
- Sponsor
- Investigators
- Kyowa Hakko Kirin Pharma, Inc., Study director, Kyowa Hakko Kirin Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610231
- Sponsor's protocol ID
- 6002-018
- Status last verified
- Apr 2024
- First submitted
- 13 Nov 2015
- Last updated
- 25 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02610231
- Acronym / sponsor ID
- 6002-018
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Parkinson's disease, Moderate to Severe Parkinson's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin Pharma, Inc.
- Study start
- Dec 2015
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Posted 13 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Istradefylline 20 mg or 40 mg | Experimental | Drug: Istradefylline 20 mg or 40 mgTreatment for 52 weeks |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Istradefylline 20 mg or 40 mgAlso: KW-6002Istradefylline 20 or 40 mg | Drug | Istradefylline 20 mg or 40 mg |
Primary outcome
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]).
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyowa Hakko Kirin Pharma, Inc. study director
Kyowa Hakko Kirin Pharma, Inc.
55 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Istradefylline 20 mg or 40 mg in people with Idiopathic Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 55 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Italy, Germany, Poland, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.