Parkinson's DiseasePhase 2NCT00455507
A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
A Phase 2 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
- 363 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2007to Aug 2008
- Phase
- Phase 2
- 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
- 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 >=300mg of levodopa per day for at least four weeks before randomization.
- Predictable end of dose wearing off.
- Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary.
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- 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.
- Be at least 20 years of age.
- Be willing and able to give written informed consent.
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 25 or less.
- History of drug or alcohol abuse or dependence within the past two years.
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- History of psychosis.
- Significant drug allergies.
- Taking anticonvulsants for seizures.
- History of neurological 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 2 Study)
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 the detailed description
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 40mg/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
Two 10 mg KW-6002 tablets orally once daily for 12 weeks
IstradefyllineDrug
Also called KW-6002
Two 20 mg tablets orally once a day for 12 weeks
PlaceboDrug
Two placebo tablets orally once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks) Receives: Drug: Istradefylline |
| 2 | Experimental | 40mg KW-6002 per day (two 20 mg KW-6002 tablets orally once daily for 12 weeks) Receives: Drug: Istradefylline |
| 3 | Placebo comparator | Two placebo tablets once daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 Parkinson's disease (PD) treated with levodopa/dopa-decarboxylase inhibitor.
Measured: Last Visit
Secondary outcomes (5)
To evaluate the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean percentage of awake time per day spent in the OFF state.
Measured: Every Visit
To evaluate 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).
Measured: Every Visit
To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS).
Measured: Every Visit
To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).
Measured: Visit 4 and Last Visit
To evaluate the safety of 20 mg/day and 40mg/day doses of istradefylline
Measured: Every Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionAug 2008
- Study completionAug 2008
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 363 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
- NCT00455507
- Sponsor's protocol ID
- 6002-0608
- Status last verified
- Aug 2012
- First submitted
- 2 Apr 2007
- 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 2 Study)
- ClinicalTrials.gov ID
- NCT00455507
- Acronym / sponsor ID
- 6002-0608
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, levodopa, end of dose wearing off, OFF time
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 3 Apr 2007 (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.
Detailed description
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 40mg/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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Istradefylline20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks) |
| 2 | Experimental | Drug: Istradefylline40mg KW-6002 per day (two 20 mg KW-6002 tablets orally once daily for 12 weeks) |
| 3 | Placebo comparator | Drug: PlaceboTwo placebo tablets once daily for 12 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 >=300mg of levodopa per day for at least four weeks before randomization.
- Predictable end of dose wearing off.
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 25 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-6002Two 10 mg KW-6002 tablets orally once daily for 12 weeks | Drug | 1 |
| IstradefyllineAlso: KW-6002Two 20 mg tablets orally once a day for 12 weeks | Drug | 2 |
| PlaceboTwo placebo tablets orally once daily for 12 weeks | Drug | 3 |
Primary outcome
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 Parkinson's disease (PD) treated with levodopa/dopa-decarboxylase inhibitor.
Time frame: Last Visit
5 secondary outcomes
To evaluate the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean percentage of awake time per day spent in the OFF state.
Time frame: Every Visit
To evaluate 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).
Time frame: Every Visit
To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS).
Time frame: Every Visit
To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).
Time frame: Visit 4 and Last Visit
To evaluate the safety of 20 mg/day and 40mg/day doses of istradefylline
Time frame: Every Visit
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 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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 Parkinson's disease (PD) treated with levodopa/dopa-decarboxylase inhibitor. (time frame: Last Visit). 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.