Parkinson's DiseasePhase 2NCT00456586
12-Week, Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of 40 mg/Day KW-6002 in Parkinson's Disease Patients on Levodopa/Carbidopa
A Phase 2 study testing KW-6002 (istradefylline) in people with Parkinson's Disease, run by Kyowa Kirin, Inc. at 1 site in United States.
Trial summary
12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with OFF phenomena advanced PD who were treated with levodopa/carbidopa. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- KW-6002 (istradefylline)
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Jun 2003
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- United Kingdom Parkinson's Disease Society brain bank diagnostic criteria (step 1 and 2).
- Modified Hoehn and Yahr Scale II-IV in the OFF state.
- Treated with levodopa/carbidopa for 1 year with a stable regimen for 4 weeks prior to randomization.
- Taking at least 4 doses of levodopa (3 doses if at least 2 doses containing slow release formulation) per day with predictable end of dose wearing off.
- Successfully completed Parkinson's disease patient diary training with at least 120 minutes of OFF time per day.
- Stable regimen of other antiparkinson's disease medications for at least 4 weeks prior to randomization.
- At least 30 years of age and able to give written informed consent.
Who cannot join
- Treatment with liquid levodopa/carbodopa within 4 weeks of randomization.
- Treatment with MAO inhibitors except selegiline.
- Treatment with centrally acting dopamine antagonists within 3 months (6 months for depot preparations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine.
- Neurosurgical surgery for Parkinson's disease.
- Atypical parkinsonism or secondary parkinsonism variants.
- Diagnosis of cancer or evidence of continued cancer within 5 years of enrollment or clinically significant illness of any organ system (e.g., ALT or AST > 1.5 times the upper limit of normal).
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- Mini-Mental Status Examination score of 25 or less.
- History of drug or alcohol abuse or dependence within 2 years.
- History of psychotic illness or seizures.
- Current clinically relevant depression disorder.
- History of neuroleptic malignant syndrome.
- Pregnant or lactating females. Women of child-bearing potential must use reliable method of contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Kyowa Pharmacuetical Inc.
Princeton, New Jersey, 08540
About this study
Official title: A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of 40 mg/Day KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy
12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with OFF phenomena advanced PD who were treated with levodopa/carbidopa.
Read the detailed description
A 12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with OFF phenomena advanced PD who were treated with levodopa/carbidopa.
- Conditions
- Parkinson's Disease
- Being tested
- KW-6002 (istradefylline)
- Keywords
- Parkinson's disease, Levodopa therapy, 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.
KW-6002 (istradefylline)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and efficacy of 40 mg/day istradefylline for reducing OFF time in subjects with Parkinson's disease (PD) treated with levodopa/carbidopa.
Secondary outcomes (1)
To establish the efficacy of 40 mg/day istradefylline for reducing motor symptoms and improving activities of daily living (ADL) in subjects with advanced PD treated with levodopa/carbidopa.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startApr 2002
- Primary completionMay 2003
- Study completionJun 2003
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.
- 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
- Double blind
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil Sussman, MD, Study director, Kyowa Kirin, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456586
- Sponsor's protocol ID
- 6002-US-005
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2007
- Last updated
- 25 Apr 2024
- Results posted
- No
- 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 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of 40 mg/Day KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy
- ClinicalTrials.gov ID
- NCT00456586
- Acronym / sponsor ID
- 6002-US-005
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, Levodopa therapy, End of dose wearing off, Off time
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- Kyowa Kirin, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- May 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 5 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.
12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with OFF phenomena advanced PD who were treated with levodopa/carbidopa.
Detailed description
A 12-week, double-blind, placebo-controlled, multicenter, randomized study designed to evaluate the safety and efficacy of 40 mg/day istradefylline compared with placebo in subjects with OFF phenomena advanced PD who were treated with levodopa/carbidopa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- United Kingdom Parkinson's Disease Society brain bank diagnostic criteria (step 1 and 2).
- Modified Hoehn and Yahr Scale II-IV in the OFF state.
- Treated with levodopa/carbidopa for 1 year with a stable regimen for 4 weeks prior to randomization.
- Taking at least 4 doses of levodopa (3 doses if at least 2 doses containing slow release formulation) per day with predictable end of dose wearing off.
- Successfully completed Parkinson's disease patient diary training with at least 120 minutes of OFF time per day.
Key exclusion criteria (12 listed)
- Treatment with liquid levodopa/carbodopa within 4 weeks of randomization.
- Treatment with MAO inhibitors except selegiline.
- Treatment with centrally acting dopamine antagonists within 3 months (6 months for depot preparations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine.
- Neurosurgical surgery for Parkinson's disease.
- Atypical parkinsonism or secondary parkinsonism variants.
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 |
|---|---|---|
| KW-6002 (istradefylline) | Drug | – |
Primary outcome
To evaluate the safety and efficacy of 40 mg/day istradefylline for reducing OFF time in subjects with Parkinson's disease (PD) treated with levodopa/carbidopa.
1 secondary outcome
To establish the efficacy of 40 mg/day istradefylline for reducing motor symptoms and improving activities of daily living (ADL) in subjects with advanced PD treated with levodopa/carbidopa.
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 25 Apr 2024.
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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.
Neil Sussman, MD study director
Kyowa Kirin, Inc.
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 KW-6002 (istradefylline) in people with Parkinson's Disease, run by Kyowa Kirin, Inc. at 1 site in United States.
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 7 inclusion and 12 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 1 site in United States. 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 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 evaluate the safety and efficacy of 40 mg/day istradefylline for reducing OFF time in subjects with Parkinson's disease (PD) treated with levodopa/carbidopa.. 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.