Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
NCT02610231 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase 3, 52-week, open-label, flexible-dose, multinational, multicenter study to evaluate the safety and tolerability of istradefylline 20 or 40 mg/d in subjects with moderate to severe PD with motor fluctuations and dyskinesia on levodopa combination (levodopa/carbidopa or levodopa/benserazide) therapy plus at least one adjunctive PD medication. Subjects who completed 12 weeks of double-blind treatment and the 30-day follow-up period in Study No. 6002-014 will undergo Screening and Baseline evaluations for eligibility for the study. Eligible subjects will be treated with istradefylline at a starting dose of 20 mg/d with an option for a dose adjustment to 40 mg/d at Week 12 based on the Investigator's judgment of each subject's response and tolerability. If deemed necessary, one unscheduled dose adjustment visit between Week 2 to Week 12 is allowed in accordance with clinical judgment of the Investigator. Subjects who had a dose adjustment to 40 mg/d can have their dose decreased to 20 mg/d by the Investigator at a second unscheduled dose adjustment visit if there are tolerability issues. The istradefylline dose should remain fixed between Week 26 to Week 52. Consultation with the Sponsor's Medical Monitor is required prior to any unscheduled dose adjustment visits. A subject may discontinue from the study at any time.
Conditions Studied
Interventions
- DRUG Istradefylline 20 mg or 40 mg
Study Locations (20)
California
- Kyowa PD Site — Fountain Valley
- Kyowa PD Site — Los Angeles
- Kyowa PD Site — Oxnard
- Kyowa PD Site — Torrance
Arizona
- Kyowa PD Site — Phoenix
- Kyowa PD Site — Sun City
- Kyowa PD Site — Tucson
Florida
- Kyowa PD Site — Boca Raton
- Kyowa PD Site — Port Charlotte
- Kyowa PD Site — Tampa
Georgia
- Kyowa PD Site — Atlanta
- Kyowa PD Site — Augusta
New York
- Kyowa PD Site — Albany
- Kyowa PD Site — New York
Colorado
- Kyowa PD Site — Englewood
Connecticut
- Kyowa PD Site — Danbury
Iowa
- Kyowa PD Site — Des Moines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 239 participants |
| Start Date | 2015-12 |
| Est. Completion | 2017-12-20 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02610231
The ClinicalTrials.gov registry entry for NCT02610231 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 239 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kyowa Kirin Co., which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Idiopathic Parkinson's Disease appearing as the primary indexed condition, and to 1 intervention — of which Istradefylline 20 mg or 40 mg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02610231 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02610231 about?
NCT02610231 is a clinical study titled "Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease". This is a Phase 3, 52-week, open-label, flexible-dose, multinational, multicenter study to evaluate the safety and tolerability of istradefylline 20 or 40 mg/d in subjects with moderate to severe PD with motor fluctuations and dyskinesia on levodopa combination (levodopa/carbidopa or levodopa/benser...
What is the current status of trial NCT02610231?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 239 participants. The study started on 2015-12. Estimated completion is 2017-12-20.
What conditions does trial NCT02610231 study?
This clinical trial studies the following conditions: Idiopathic Parkinson's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02610231?
The interventions under investigation include: Istradefylline 20 mg or 40 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02610231?
This trial is sponsored by Kyowa Kirin Co., which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02610231 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.