Parkinson's DiseasePhase 3NCT00199394
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease
A Phase 3 study testing Istradefylline (KW-6002) in people with Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the efficacy of 40 mg a day of istradefylline (KW-6002) for reducing the percentage of awake time spent in the OFF state in patients with advanced Parkinson's disease treated with levodopa. 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?
- Istradefylline (KW-6002)
- How many people
- 405 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2004to Nov 2005
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients selected for this study will be at least 30 years of age and will have been diagnosed with advanced Parkinson's disease as determined by UK Parkinson's Disease Society (UKPDS) criteria and the Modified Hoehn and Yahr Scale. The patients will have been receiving levodopa treatment for at least one year, may be taking other antiparkinsonian drugs, will have an average of at least three hours OFF time as recorded in two 24-hour ON/OFF diaries, and if female, must be non-pregnant and non-nursing.
Who cannot join
- Patients may not be enrolled if they are taking certain medications excluded by the protocol, have been treated with any investigational drug within 30 days prior to randomisation (or five half-lives if longer), have ever received istradefylline or been treated with a COMT inhibitor, are psychotic, have clinically significant illness or laboratory values at screening, have insufficient mental capacity to comply with protocol requirements or certain psychiatric or neurological conditions.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/Day KW-6002 (Istradefylline) and That of Entacapone Versus Placebo as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.
The purpose of this study is to evaluate the efficacy of 40 mg a day of istradefylline (KW-6002) for reducing the percentage of awake time spent in the OFF state in patients with advanced Parkinson's disease treated with levodopa.
Read the detailed description
Parkinson's disease (PD) is a progressive motor disease characterized by bradykinesia or akinesia, rigidity, and resting tremor. Levodopa is still the most widely used treatment for PD, but as the disease progresses the drug tends to become less helpful. This is because of the development of motor response complications such as end-of-dose deterioration or wearing-off, peak dose dyskinesias, and ON-OFF phenomenon.
Comparison(s): The safety of 40 mg/d istradefylline and the efficacy for reducing the percentage of OFF time in patients with advanced PD treated with levodopa will be compared to placebo. The safety and efficacy of Entacapone will also be compared to placebo.
- Conditions
- Parkinson's Disease
- Being tested
- Istradefylline (KW-6002)
- Keywords
- KW-6002 (istradefylline), Entacapone, Placebo, Parkinson's Disease, Motor Response Complications, Levodopa Therapy
- 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 (KW-6002)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
OFF time assessed by patient diaries at endpoint.
Secondary outcomes (8)
Efficacy: OFF time
ON time
UPDRS (parts I-IVa)
PDQ-39, PCG-I, CGI-S and SF-36 scores at endpoint.
Safety: clinical laboratory tests
12-lead ECG
vital signs
physical (including neurological) examination and adverse events throughout.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionOct 2005
- Study completionNov 2005
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
- Enrolment
- 405 participants
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin UK, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199394
- Sponsor's protocol ID
- 6002-EU-007
- Status last verified
- Apr 2024
- First submitted
- 12 Sep 2005
- 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 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/Day KW-6002 (Istradefylline) and That of Entacapone Versus Placebo as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.
- ClinicalTrials.gov ID
- NCT00199394
- Acronym / sponsor ID
- 6002-EU-007
- Conditions
- Parkinson's Disease
- Keywords
- KW-6002 (istradefylline), Entacapone, Placebo, Parkinson's Disease, Motor Response Complications, Levodopa Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin UK, Ltd.
- Study start
- Nov 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 20 Sep 2005 (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 evaluate the efficacy of 40 mg a day of istradefylline (KW-6002) for reducing the percentage of awake time spent in the OFF state in patients with advanced Parkinson's disease treated with levodopa.
Detailed description
Parkinson's disease (PD) is a progressive motor disease characterized by bradykinesia or akinesia, rigidity, and resting tremor. Levodopa is still the most widely used treatment for PD, but as the disease progresses the drug tends to become less helpful. This is because of the development of motor response complications such as end-of-dose deterioration or wearing-off, peak dose dyskinesias, and ON-OFF phenomenon.
Comparison(s): The safety of 40 mg/d istradefylline and the efficacy for reducing the percentage of OFF time in patients with advanced PD treated with levodopa will be compared to placebo. The safety and efficacy of Entacapone will also be compared to placebo.
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 (1 listed)
- Patients selected for this study will be at least 30 years of age and will have been diagnosed with advanced Parkinson's disease as determined by UK Parkinson's Disease Society (UKPDS) criteria and the Modified Hoehn and Yahr Scale. The patients will have been receiving levodopa treatment for at least one year, may be taking other antiparkinsonian drugs, will have an average of at least three hours OFF time as recorded in two 24-hour ON/OFF diaries, and if female, must be non-pregnant and non-nursing.
Key exclusion criteria (2 listed)
- Patients may not be enrolled if they are taking certain medications excluded by the protocol, have been treated with any investigational drug within 30 days prior to randomisation (or five half-lives if longer), have ever received istradefylline or been treated with a COMT inhibitor, are psychotic, have clinically significant illness or laboratory values at screening, have insufficient mental capacity to comply with protocol requirements or certain psychiatric or neurological conditions.
- -
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 (KW-6002) | Drug | – |
Primary outcome
OFF time assessed by patient diaries at endpoint.
8 secondary outcomes
Efficacy: OFF time
ON time
UPDRS (parts I-IVa)
PDQ-39, PCG-I, CGI-S and SF-36 scores at endpoint.
Safety: clinical laboratory tests
12-lead ECG
vital signs
physical (including neurological) examination and adverse events throughout.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 (KW-6002) in people with Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 1 site in United Kingdom.
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 1 inclusion and 2 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 Kingdom. 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?
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?
OFF time assessed by patient diaries at endpoint.. 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.