Parkinson's DiseasePhase 3NCT00203957
Study of KW-6002 (Istradefylline) in Parkinson's Disease in Patients With Motor Response Complications on Levodopa
A Phase 3 study testing Istradefylline in people with Parkinson's Disease, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to confirm the long term tolerability and safety of oral 20 or 40 mg/d doses of Istradefylline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Istradefylline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who completed double-blind treatment study 6002-US-0 13, 6002-US-0 18 or 6002-EU-007, or who discontinued from open-label study 6002-US-007.
- Patients who are female must be non-pregnant and non-nursing. Women of Child Bearing Potential (WOCBP) must use a reliable method of contraception (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive, double- bather methods, such as condom and diaphragm, condom and foam, condom and sponge or intra-uterine devices) and have a negative serum (North American sites) or urine (non-North American sites) pregnancy test at screening and at baseline. Women are considered to not be of childbearing potential if they have been surgically sterilized.
- Patients who are able to give written informed consent
Who cannot join
- Group B Patients who are treated within 30 days before baseline (or five half-lives of the compound, if longer) with any investigational agent other than istradefylline
- Patients who have a history of a psychotic illness.
- Patients who are treated within three months (six months if patient was treated with depot) before baseline or during the trial with an anti-psychotic agent.
- Patients who are treated with any centrally acting drug that has known dopamine antagonist properties at therapeutic doses (e.g., buspirone, amoxapine).
- Patients who have atypical parkinsonism.
- Patients who have secondary parkinsonism variants.
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- Patients who have a diagnosis of cancer or evidence of continued malignancy within five years of study enrollment (except for patients that have had basal cell carcinoma or carcinoma in situ of the cervix surgically excised).
- Patients who have a clinically significant illness of any organ system which may compromise the safety of the patient during the trial or affect the ability of the patient to complete the trial.
- Patients who, for any reason, are judged by the Investigator to be inappropriate for this trial, including a patient who is unable to communicate or to cooperate with the Investigator.
- Patients who have an ALT and/or an AST level greater than 1.5 ULN at screening will be ineligible to participate in the trial.
- Patients who have a history of drug or alcohol abuse or dependence within the last year (DSM-IVR).
- Patients with significant drug allergies.
Trial locations and contacts
1 site in 1 country.
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
The purpose of this study is to confirm the long term tolerability and safety of oral 20 or 40 mg/d doses of Istradefylline.
Read the detailed description
This is a Phase III open-label study, in which patients with Parkinson's disease (PD) who have completed a qualifying istradefylline study will be treated with istradefylline for a period of up to one additional year. Starting dosage of istradefylline will be 40 mg/d and maintenance dosage will be at the discretion of the Investigator. The available doses for istradefylline are 20 and 40 mg/d. Open-label istradefylline treatment will be initiated after a patient has satisfied all criteria for participation.
Patients will undergo screening and baseline evaluations during which they will be assessed for eligibility. Screening procedures will vary slightly depending upon the allocation of patients to one of the following two groups:
Group A: Patients who have completed double-blind treatment studies 6002-US-0 13, 6002- US-Ol S or 6002-EU-007 immediately prior to entering this open-label trial and may have had an interruption of study drug of 14 days or less. The screening visit for these patients will correspond to the final visit of the previous istradefylline study.
Group B: Patients who have previously completed double-blind treatment studies 6002-US- 013, 6002-US-O 18 or 6002-EU-007 or discontinued from open-label study 6002-US-007 and have had an interruption of study drug greater than 14 days. Screening for these patients will occur at the Week -2 and Day -1 Visits.
Visits should occur in the ON state and procedures should be conducted in the order specified, whenever possible.
Safety outcomes will be assessed by physical examination (including neurological examination), clinical laboratory tests and 12-lead electrocardiogram (ECG) at screening and at selected subsequent scheduled visits. Vital signs, including weight, concomitant medications, and adverse events will be monitored regularly throughout the trial. Changes in anti-parkinsonian medications will be permitted at the Investigator's discretion.
- Conditions
- Parkinson's Disease
- Being tested
- Istradefylline
- Keywords
- Parkinson's Disease
- 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
Patients will receive starting dose of 40mg/d. The allowable doses are 20 and 40mg/d
IstradefyllineDrug
Patients will receive starting dose of 40mg/d. The allowable doses are 20 and 40mg/d
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients who completed double-blind treatment studies 6002-US-013, 6002-US-013, 6002-US-018 immediately prior to entering this open-label trial and may have had an interuption of study drug of 14 days or less. Receives: Drug: Istradefylline |
| Group B | Experimental | Patients who previously completed double-blind treatment studies 6002-US-013, 6002-US-018 or 6002-EU-007 or discontinued from open label study 6002-US-007 and have had an interuption of study drug greater than 14 days. Receives: Drug: Istradefylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety profile of istradefylline
Measured: 52 weeks
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 startMar 2005
- Primary completionFeb 2007
- Study completionFeb 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.
- More trials run by University of ChicagoThe 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
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arif Dalvi, M.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203957
- Sponsor's protocol ID
- 13711A
- Other IDs
- Kyowa Pharmaceuticals
- Status last verified
- Jun 2013
- First submitted
- 13 Sep 2005
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. 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
- NCT00203957
- Acronym / sponsor ID
- 13711A
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 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.
The purpose of this study is to confirm the long term tolerability and safety of oral 20 or 40 mg/d doses of Istradefylline.
Detailed description
This is a Phase III open-label study, in which patients with Parkinson's disease (PD) who have completed a qualifying istradefylline study will be treated with istradefylline for a period of up to one additional year. Starting dosage of istradefylline will be 40 mg/d and maintenance dosage will be at the discretion of the Investigator. The available doses for istradefylline are 20 and 40 mg/d. Open-label istradefylline treatment will be initiated after a patient has satisfied all criteria for participation.
Patients will undergo screening and baseline evaluations during which they will be assessed for eligibility. Screening procedures will vary slightly depending upon the allocation of patients to one of the following two groups:
Group A: Patients who have completed double-blind treatment studies 6002-US-0 13, 6002- US-Ol S or 6002-EU-007 immediately prior to entering this open-label trial and may have had an interruption of study drug of 14 days or less. The screening visit for these patients will correspond to the final visit of the previous istradefylline study.
Group B: Patients who have previously completed double-blind treatment studies 6002-US- 013, 6002-US-O 18 or 6002-EU-007 or discontinued from open-label study 6002-US-007 and have had an interruption of study drug greater than 14 days. Screening for these patients will occur at the Week -2 and Day -1 Visits.
Visits should occur in the ON state and procedures should be conducted in the order specified, whenever possible.
Safety outcomes will be assessed by physical examination (including neurological examination), clinical laboratory tests and 12-lead electrocardiogram (ECG) at screening and at selected subsequent scheduled visits. Vital signs, including weight, concomitant medications, and adverse events will be monitored regularly throughout the trial. Changes in anti-parkinsonian medications will be permitted at the Investigator's discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: IstradefyllinePatients who completed double-blind treatment studies 6002-US-013, 6002-US-013, 6002-US-018 immediately prior to entering this open-label trial and may have had an interuption of study drug of 14 days or less. |
| Group B | Experimental | Drug: IstradefyllinePatients who previously completed double-blind treatment studies 6002-US-013, 6002-US-018 or 6002-EU-007 or discontinued from open label study 6002-US-007 and have had an interuption of study drug greater than 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who completed double-blind treatment study 6002-US-0 13, 6002-US-0 18 or 6002-EU-007, or who discontinued from open-label study 6002-US-007.
- Patients who are female must be non-pregnant and non-nursing. Women of Child Bearing Potential (WOCBP) must use a reliable method of contraception (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive, double- bather methods, such as condom and diaphragm, condom and foam, condom and sponge or intra-uterine devices) and have a negative serum (North American sites) or urine (non-North American sites) pregnancy test at screening and at baseline. Women are considered to not be of childbearing potential if they have been surgically sterilized.
- Patients who are able to give written informed consent
Key exclusion criteria (12 listed)
- Group B Patients who are treated within 30 days before baseline (or five half-lives of the compound, if longer) with any investigational agent other than istradefylline
- Patients who have a history of a psychotic illness.
- Patients who are treated within three months (six months if patient was treated with depot) before baseline or during the trial with an anti-psychotic agent.
- Patients who are treated with any centrally acting drug that has known dopamine antagonist properties at therapeutic doses (e.g., buspirone, amoxapine).
- Patients who have atypical parkinsonism.
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 |
|---|---|---|
| IstradefyllinePatients will receive starting dose of 40mg/d. The allowable doses are 20 and 40mg/d | Drug | Group A |
| IstradefyllinePatients will receive starting dose of 40mg/d. The allowable doses are 20 and 40mg/d | Drug | Group B |
Primary outcome
To evaluate the safety profile of istradefylline
Time frame: 52 weeks
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 11 Jun 2013.
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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.
Arif Dalvi, M.D. principal investigator
University of Chicago
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 University of Chicago 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 3 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 11 Jun 2013. 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?
To evaluate the safety profile of istradefylline (time frame: 52 weeks). 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 11 Jun 2013.