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NCT02610231 · ClinicalTrials.gov registry record · Phase 3
Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
A Phase 3 study of Idiopathic Parkinson´s Disease, sponsored by Kyowa Kirin Co..
- Completed
- Registry status
- Phase 3
- Development phase
- 239
- Enrollment target
- 20
- Study locations
NCT02610231 is a Phase 3 study of Idiopathic Parkinson´s Disease that has completed, run by Kyowa Kirin Co.. The registered enrollment target is 239 participants, above the 186-participant average among 7 other Idiopathic Parkinson´s Disease trials with a reported enrollment target (28% higher). The trial reports 20 study locations across 11 states.
The verdict
NCT02610231, a Phase 3 study of Idiopathic Parkinson´s Disease, has completed, sponsored by Kyowa Kirin Co..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 239 participants
- Enrollment target
- 20
- Study locations
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?
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, categorized as Phase 3. The registered enrollment target is 239 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 186-participant average among 7 other Idiopathic Parkinson´s Disease trials with a reported enrollment target (28% higher). The listed sponsor is Kyowa Kirin Co., which has 25 total studies on file at ClinicalTrials.gov.
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.
NCT02610231 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Arizona, Florida.
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.
What interventions are being tested in trial NCT02610231?
The interventions under investigation include: Istradefylline 20 mg or 40 mg (DRUG).
Who is sponsoring clinical trial NCT02610231?
This trial is sponsored by Kyowa Kirin Co., which has 25 total clinical trials registered on ClinicalTrials.gov.
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.
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Related
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