Parkinson's DiseasePhase 3NCT00199368
An Extension of Istradefylline in Parkinson's Disease Patients Who Have Completed Studies 6002-EU-007, 6002-US-013 or 6002-US-018
A Phase 3 study testing Istradefylline ( KW-6002) in people with Parkinson's Disease, run by Kyowa Kirin, Inc. at 1 site in United States.
Trial summary
This is a 1-year, open-label, long-term safety extension for patients who have completed prior istradefylline studies 6002-EU-007, 6002-US-013 or 6002-US-018. 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
- 1,100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to May 2007
- 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
- Completion of study 6002-EU-007, 6002-US-013 or 6002-US-018
- Non-pregnant and either not of childbearing potential or using specified contraception
Who cannot join
- History of psychotic illness
- Variant/atypical Parkinson's disease
- Cancer within 5 years of enrollment
- ALT/AST levels > 1.5 times ULN
- Seizure disorder
- Neuroleptic malignant syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Kyowa Pharmaceutical Inc.
Princeton, New Jersey, 08540
About this study
Official title: A Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.
This is a 1-year, open-label, long-term safety extension for patients who have completed prior istradefylline studies 6002-EU-007, 6002-US-013 or 6002-US-018.
Read the detailed description
Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind studies 6002-EU-007, 6002-US-013 or 6002-US-018 are eligible to enter into this 1-year, long-term open safety study with a starting istradefylline dose of 40mg per day.
- Conditions
- Parkinson's Disease
- Being tested
- Istradefylline ( KW-6002)
- 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.
Istradefylline ( KW-6002)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Secondary outcomes (1)
Safety
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 startOct 2004
- Primary completionMar 2007
- Study completionMay 2007
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,100 participants
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin UK, Ltd.
- Responsible party
- Sponsor
- Investigators
- Neil Sussman, MD, Study director, Kyowa Kirin, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199368
- Sponsor's protocol ID
- 6002-INT-001
- 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 Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.
- ClinicalTrials.gov ID
- NCT00199368
- Acronym / sponsor ID
- 6002-INT-001
- 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
- 1,100 participants
- Lead sponsor
- Kyowa Kirin, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin UK, Ltd.
- Study start
- Oct 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- May 2007 (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.
This is a 1-year, open-label, long-term safety extension for patients who have completed prior istradefylline studies 6002-EU-007, 6002-US-013 or 6002-US-018.
Detailed description
Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind studies 6002-EU-007, 6002-US-013 or 6002-US-018 are eligible to enter into this 1-year, long-term open safety study with a starting istradefylline dose of 40mg per day.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completion of study 6002-EU-007, 6002-US-013 or 6002-US-018
- Non-pregnant and either not of childbearing potential or using specified contraception
Key exclusion criteria (6 listed)
- History of psychotic illness
- Variant/atypical Parkinson's disease
- Cancer within 5 years of enrollment
- ALT/AST levels > 1.5 times ULN
- Seizure disorder
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
Safety
1 secondary outcome
Safety
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 3 study testing Istradefylline ( KW-6002) 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 2 inclusion and 6 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 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?
Safety. 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.