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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 is a Phase 3 study that has completed, run by Kyowa Kirin Co.. The registered enrollment target is 613 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01968031
The ClinicalTrials.gov registry entry for NCT01968031 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 613 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kyowa Kirin Co., which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01968031 reports 0 study locations.
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.
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