Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01968031 · ClinicalTrials.gov registry record · Phase 3
A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
A Phase 3 study, sponsored by Kyowa Kirin Co..
- Completed
- Registry status
- Phase 3
- Development phase
- 613
- Enrollment target
NCT01968031: Completed Phase 3 study, sponsored by Kyowa Kirin Co..
NCT01968031 is a Phase 3 study that has completed, run by Kyowa Kirin Co.. The registered enrollment target is 613 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01968031, a Phase 3 study, has completed, sponsored by Kyowa Kirin Co..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 613 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Based on the 24-hour ON/OFF patient diary data.
Interventions
- DRUG Placebo
- DRUG Istradefylline 40 mg
- DRUG Istradefylline 20 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 613 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-10 |
| Phase | Phase 3 |
What the finished NCT01968031 record still lists
NCT01968031 is an interventional study that assigns participants to a tested intervention. The registered 613 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01968031 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01968031 about?
NCT01968031 is a clinical study titled "A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease". 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 adjun...
What is the current status of trial NCT01968031?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 613 participants. The study started on 2013-10. Estimated completion is 2016-10.
What interventions are being tested in trial NCT01968031?
The interventions under investigation include: Placebo (DRUG), Istradefylline 40 mg (DRUG), Istradefylline 20 mg (DRUG).
Who is sponsoring clinical trial NCT01968031?
This trial is sponsored by Kyowa Kirin Co., which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01968031's enrollment target sits among peer trials
613 598th of 2000 higher than 1,403 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01810913 · 613 participants · Phase 2
Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer
- NCT03821857 · 614 participants · Phase 4
Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease
- NCT05006716 · 614 participants · Phase 1
A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
- NCT06170788 · 614 participants · Phase 3
Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia