22 completed, 2 not yet recruiting, 2 terminated, 1 active not recruiting. 12 Phase 2, 11 Phase 3, 6 Phase 1, 1 Phase 4.
Follow istradefylline: new trials by email Literature Review of istradefylline trials Research Report on istradefylline
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Combining Low Oxygen Therapy and an Adenosine A2a Receptor Antagonist to Improve Functional Mobility After Spinal Cord Injury Istradefylline, low oxygen therapy - Spinal Cord Injuries, Myelopathy | Phase 1 / Phase 2 | Not yet recruiting | Randy Trumbower, PT, PhD | 40 | 2027-09-01 | 2026-03-20 |
| Enhancing Rehabilitation in Aging Study (ERAS) Istradefylline 20 mg, Placebo, Acute Intermittent Hypoxia (AIH) - Adults | Phase 1 / Phase 2 | Not yet recruiting | University of Florida | 38 | 2026-10-01 | 2026-07-15 |
| Istradefylline Effect Protocol on Parkinson's Disease Tremor Istradefylline Pill - Parkinson Disease, Tremor | Phase 4 | Completed | Georgetown University | 27 | 2023-01-20 | 2025-03-13 |
| Effect of Istradefylline Treatment on Behavioral Measures of Apathy in Parkinson's Disease. Istradefylline 40 mg - Apathy, Parkinson Disease | Terminated | Medical University of South Carolina | 8 | 2022-07-29 | 2026-02-02 | |
| Adenosine 2A Receptor Antagonism and AIH in ALS Consume 20mg of istradefylline, Low Oxygen therapy, Placebo counterpart to the istradefylline drug - ALS | Phase 1 / Phase 2 | Active not recruiting | University of Florida | 40 | 2022-06-21 | 2026-03-27 |
| A Study to Evaluate Abuse Potential of Istradefylline Istradefylline, Phentermine 45 mg, Placebo - Drug Abuse | Phase 1 | Completed | Kyowa Kirin Co., Ltd. | 42 | 2016-01-01 | 2024-04-25 |
| Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease Istradefylline 20 mg or 40 mg - Idiopathic Parkinson's Disease | Phase 3 | Completed | Kyowa Kirin Co., Ltd. | 239 | 2015-12-01 | 2024-04-25 |
| Effect of Mild Hepatic Impairment on the Pharmacokinetics of Istradefylline Istradefylline - Hepatic Impairment | Phase 1 | Completed | Kyowa Kirin Co., Ltd. | 20 | 2014-08-01 | 2024-04-25 |
| The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers. Istradefylline 40 mg, Rifampin 300mg BID + istradefylline 40mg Day 8 only - Parkinson's Disease | Phase 1 | Completed | Kyowa Kirin Co., Ltd. | 20 | 2014-06-01 | 2024-04-25 |
| A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease Istradefylline 40 mg, Istradefylline 20 mg, Placebo - Idiopathic Parkinson's Disease | Phase 3 | Completed | Kyowa Kirin Co., Ltd. | 613 | 2013-10-01 | 2024-04-25 |
| Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients Istradefylline - Parkinson's Disease | Phase 3 | Completed | Kyowa Kirin Co., Ltd. | 308 | 2009-10-01 | 2012-08-31 |
| Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa Istradefylline, Placebo - Parkinson's Disease | Phase 3 | Completed | Kyowa Kirin Co., Ltd. | 373 | 2009-07-01 | 2012-08-29 |
| A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa Istradefylline, Placebo - Parkinson's Disease | Phase 2 | Completed | Kyowa Kirin Co., Ltd. | 363 | 2007-03-01 | 2012-08-29 |
| A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease Istradefylline (KW-6002) - Parkinson's Disease | Phase 2 | Completed | Kyowa Kirin Co., Ltd. | 64 | 2005-11-01 | 2012-08-29 |
| An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001 Istradefylline - Parkinson's Disease | Phase 3 | Terminated | Kyowa Kirin, Inc. | 504 | 2005-10-01 | 2024-05-17 |
| Study of Istradefylline (KW-6002) for the Treatment of Restless Legs Syndrome Istradefylline (KW-6002) - Sleep Disorder, Restless Legs Syndrome | Phase 2 | Completed | Kyowa Kirin, Inc. | 160 | 2005-07-01 | 2024-04-25 |
| A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) Patients Istradefylline (KW-6002) - Parkinson's Disease, Movement Disorder Syndrome | Phase 2 | Completed | Kyowa Kirin, Inc. | 160 | 2005-05-01 | 2024-04-25 |
| A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa Istradefylline (KW-6002) - Parkinson's Disease | Phase 2 | Completed | Kyowa Kirin Co., Ltd. | 75 | 2005-04-01 | 2014-05-23 |
| Study of KW-6002 (Istradefylline) in Parkinson's Disease in Patients With Motor Response Complications on Levodopa Istradefylline - Parkinson's Disease | Phase 3 | Completed | University of Chicago | 10 | 2005-03-01 | 2013-06-11 |
| A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease Istradefylline (KW-6002) - Parkinson's Disease | Phase 3 | Completed | Kyowa Kirin Co., Ltd. | 405 | 2004-11-01 | 2024-04-25 |
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Parkinson Disease (21) · Dyskinesias (1) · Hypoxia (1) · Lethargy (1) · Movement Disorders (1) · Respiratory Aspiration (1) · Restless Legs Syndrome (1) · Sleep Wake Disorders (1) · Spinal Cord Diseases (1) · Spinal Cord Injuries (1) · Substance-Related Disorders (1) · Tremor (1)
Kyowa Kirin Co., Ltd. (11) · Kyowa Kirin, Inc. (9) · University of Florida (2) · Georgetown University (1) · Medical University of South Carolina (1) · National Institute of Neurological Disorders and Stroke (NINDS) (1) · Randy Trumbower, PT, PhD (1) · University of Chicago (1)
United States (20) · Japan (5) · Canada (2) · Czechia (2) · Germany (2) · Israel (2) · Italy (2) · Poland (2) · Serbia (2) · United Kingdom (1)
Neil Sussman, MD (7) · Marc Cantillon, M.D. (2) · Amy Zhang, PhD (1) · Amy Zhang, PhD. (1) · Arif Dalvi, M.D. (1) · Barbara Smith (1) · Fernando Pagan (1) · James Williams, MD (1) · Lilia Lovera, MD (1) · Randy D Trumbower, PT, PhD (1)