4 completed, 4 terminated. 3 Phase 1, 3 Phase 3, 2 Phase 2, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 3 | Terminated 2, Completed 1 |
| Phase 3 | 3 | Terminated 2, Completed 1 |
| Phase 2 | 2 | Completed 2 |
| Early Phase 1 | 1 | Completed 1 |
Follow tozadenant: new trials by email Literature Review of tozadenant trials Research Report on tozadenant
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 |
|---|---|---|---|---|---|---|
| A Study to Determine the Abuse Potential of Tozadenant Relative to D-Amphetamine and Placebo When Administered Orally in Healthy, Non-Dependent, Recreational Polydrug Users Tozadenant, Placebo oral tablet, d-amphetamine - Abuse Potential | Phase 1 | Terminated | Biotie Therapies Inc. | 26 | 2017-09-18 | 2018-08-13 |
| Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Tozadenant Tozadenant - Hepatic Impairment | Phase 1 | Terminated | Biotie Therapies Inc. | 20 | 2017-06-30 | 2018-01-04 |
| Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease. Tozadenant - Idiopathic Parkinson Disease | Phase 3 | Terminated | Biotie Therapies Inc. | 66 | 2017-04-10 | 2019-05-03 |
| Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients tozadenant, placebo - Idiopathic Parkinson's Disease | Phase 3 | Terminated | Biotie Therapies Inc. | 449 | 2015-07-01 | 2019-04-03 |
| Study to Evaluate the Absorption, Distribution, Break Down and Elimination and the Safety of 14C-Labeled Tozadenant tozadenant tablet, C14-tozadenant capsule - N/A, as Healthy Volunteers | Phase 1 | Completed | Biotie Therapies Inc. | 6 | 2013-09-01 | 2017-08-04 |
| Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off Tozadenant (SYN115) 60 mg BID, Placebo, Levodopa (L-dopa) - Parkinson's Disease | Phase 2 / Phase 3 | Completed | Biotie Therapies Inc. | 420 | 2011-03-01 | 2019-01-17 |
| An fMRI Study of SYN115 in Cocaine Dependent Subjects SYN115, PLACEBO - Cocaine Dependence | Early Phase 1 | Completed | Virginia Commonwealth University | 26 | 2008-10-01 | 2019-07-19 |
| Study to Evaluate SYN115 in Parkinson's Disease Placebo, Tozadenant - Parkinson's Disease | Phase 2 | Completed | Biotie Therapies Inc. | 30 | 2008-04-01 | 2017-08-08 |
Parkinson Disease (4) · Dyskinesias (2) · Cocaine-Related Disorders (1) · Liver Diseases (1)
Biotie Therapies Inc. (7) · Virginia Commonwealth University (1)
United States (6) · Canada (4) · Argentina (1) · Austria (1) · Chile (1) · Czechia (1) · Germany (1) · Italy (1) · Netherlands (1) · Romania (1) · Spain (1) · Ukraine (1) · United Kingdom (1)
Ann Neale, RN (2) · Christopher Kenney, MD (2) · Frederick G Moeller, M.D. (1) · Kevin J Black, MD (1) · Michael McDonnell, MD (1) · Richard Preston, MD (1) · Steve Bandak, MB BS MRCP (1) · Steve Bandak, MD (1) · Uwe Meya, MD (1)
PMID 21123574, PMID 22654774, PMID 22905331, PMID 25008546
2014 (1), P50DA009262 (1)