A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
Public ClinicalTrials.gov record NCT01968031. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/Day as Treatment for Subjects With Moderate to Severe Parkinson's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinson's Disease. While on this study, participants will continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group.
Study identification
- NCT ID
- NCT01968031
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 613 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 30 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2013 (Type not available)
- Primary completion
- Oct 2016 (Actual)
- Completion
- Oct 2016 (Actual)
- Last update posted
- Apr 25, 2024
2013 – 2016
United States locations
- U.S. sites
- 41
- U.S. states
- 20
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kyowa PD Site | Phoenix | Arizona | 85004 | — |
| Kyowa PD Site | Sun City | Arizona | 85351 | — |
| Kyowa PD Site | Tucson | Arizona | 85724 | — |
| Kyowa PD Site | Fountain Valley | California | 92708 | — |
| Kyowa PD Site | Irvine | California | 92697 | — |
| Kyowa PD Site | Los Angeles | California | 90048 | — |
| Kyowa PD Site | Oxnard | California | 93030 | — |
| Kyowa PD Site | Pasadena | California | 91105 | — |
| Kyowa PD Site | Reseda | California | 91335 | — |
| Kyowa PD Site | Sunnyvale | California | 94085 | — |
| Kyowa PD Site | Torrance | California | 90505 | — |
| Kyowa PD Site | Englewood | Colorado | 80113 | — |
| Kyowa PD Site | Danbury | Connecticut | 06810 | — |
| Kyowa PD Site | Boca Raton | Florida | 33486 | — |
| Kyowa PD Site | Jacksonville | Florida | 32209 | — |
| Kyowa PD Site | Panama City | Florida | 32405 | — |
| Kyowa PD Site | Port Charlotte | Florida | 33980 | — |
| Kyowa PD Site | Tampa | Florida | 33647 | — |
| Kyowa PD Site | Atlanta | Georgia | 30329 | — |
| Kyowa PD Site | Augusta | Georgia | 29841 | — |
| Kyowa PD Site | Chicago | Illinois | 60611 | — |
| Kyowa PD Site | Chicago | Illinois | 60612 | — |
| Kyowa PD Site | Des Moines | Iowa | 50309 | — |
| Kyowa PD Site | Kansas City | Kansas | 66160 | — |
| Kyowa PD Site | Baltimore | Maryland | 21201 | — |
| Kyowa PD Site | Boston | Massachusetts | 02215 | — |
| Kyowa PD Site | West Bloomfield | Michigan | 48322 | — |
| Kyowa PD Site | Minneapolis | Minnesota | 55414 | — |
| Kyowa PD Site | St Louis | Missouri | 63110 | — |
| Kyowa PD Site | Albany | New York | 12208 | — |
| Kyowa PD Site | New York | New York | 10016 | — |
| Kyowa PD Site | New York | New York | 10032 | — |
| Kyowa PD Site | Asheville | North Carolina | 28806 | — |
| Kyowa PD Site | Durham | North Carolina | 27705 | — |
| Kyowa PD Site | Cincinnati | Ohio | 45219 | — |
| Kyowa PD Site | Cleveland | Ohio | 44195 | — |
| Kyowa PD Site | Toledo | Ohio | 43614 | — |
| Kyowa PD Site | Philadelphia | Pennsylvania | 19107 | — |
| Kyowa PD Site | Charleston | South Carolina | 29401 | — |
| Kyowa PD Site | Dallas | Texas | 75390-9036 | — |
| Kyowa PD Site | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 48 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01968031, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 25, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01968031 live on ClinicalTrials.gov.