Parkinson's DiseasePhase 36002-009NCT00955526
Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
A Phase 3 study testing Istradefylline in people with Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Istradefylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 373 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2009to Feb 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing and able to give written informed consent
- UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD
- PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale
- On levodopa/dopa-decarboxylase inhibitor for at least one year
- Taking at least three doses and >=300 mg of levodopa/dopa-decarboxylase inhibitor per day for at least four weeks before randomization
- Predictable end of dose wearing off
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- Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary
- Have an average of two hours of OFF time on 24-hour diaries
- On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization
- On a stable dose of domperidone for at least 14 days before randomization
Who cannot join
- Taking any excluded medications
- Neurosurgical treatment or Transcranial Magnetic Stimulation for PD
- Diagnosis of cancer within 5 years
- Diagnosis of clinically significant illness of any organ system
- Diagnosis of dementia or mini-mental status examination score of 23 or less
- History of drug or alcohol abuse or dependence within the past two years
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- History of psychosis
- History of significant drug allergies
- Taking anticonvulsants for seizures
- History of neuroleptic malignant syndrome
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placebo-Controlled, Double-Blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)
The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40 mg/day istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.
- Conditions
- Parkinson's Disease
- Being tested
- Istradefylline, Placebo
- Keywords
- Parkinson's disease, levodopa, end of dose wearing off, OFF time
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IstradefyllineDrug
Also called KW-6002
20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks)
IstradefyllineDrug
Also called KW-6002
40mg KW-6002 per day (two 20 mg tablets orally once daily for 12 weeks)
PlaceboDrug
Two placebo tablets once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Istradefylline 20mg | Experimental | Not described Receives: Drug: Istradefylline |
| Istradefylline 40mg | Experimental | Not described Receives: Drug: Istradefylline |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing the mean total hours of awake time per day spent in the OFF state
Secondary outcomes (5)
Reducing the mean percentage of awake time per day spent in the OFF state
Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia)
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Change in the Clinical Global Impression - Improvement scale (CGI-I)
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Kyowa Kirin Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955526
- Sponsor's protocol ID
- 6002-009
- Acronym
- 6002-009
- Status last verified
- Aug 2012
- First submitted
- 7 Aug 2009
- Last updated
- 29 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Double-Blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)
- ClinicalTrials.gov ID
- NCT00955526
- Acronym / sponsor ID
- 6002-009 / 6002-009
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, levodopa, end of dose wearing off, OFF time
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 10 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40 mg/day istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Istradefylline 20mg | Experimental | Drug: Istradefylline |
| Istradefylline 40mg | Experimental | Drug: Istradefylline |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be willing and able to give written informed consent
- UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD
- PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale
- On levodopa/dopa-decarboxylase inhibitor for at least one year
- Taking at least three doses and >=300 mg of levodopa/dopa-decarboxylase inhibitor per day for at least four weeks before randomization
Key exclusion criteria (11 listed)
- Taking any excluded medications
- Neurosurgical treatment or Transcranial Magnetic Stimulation for PD
- Diagnosis of cancer within 5 years
- Diagnosis of clinically significant illness of any organ system
- Diagnosis of dementia or mini-mental status examination score of 23 or less
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 |
|---|---|---|
| IstradefyllineAlso: KW-600220 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks) | Drug | Istradefylline 20mg |
| IstradefyllineAlso: KW-600240mg KW-6002 per day (two 20 mg tablets orally once daily for 12 weeks) | Drug | Istradefylline 40mg |
| PlaceboTwo placebo tablets once daily for 12 weeks | Drug | Placebo |
Primary outcome
Reducing the mean total hours of awake time per day spent in the OFF state
5 secondary outcomes
Reducing the mean percentage of awake time per day spent in the OFF state
Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia)
Change in Unified Parkinson's Disease Rating Scale (UPDRS)
Change in the Clinical Global Impression - Improvement scale (CGI-I)
Adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2012.
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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.
Study Director study director
Kyowa Kirin Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Istradefylline in people with Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
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 10 inclusion and 11 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 29 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reducing the mean total hours of awake time per day spent in the OFF state. 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 29 Aug 2012.