K. Kieburtz, C. Olanow, J. Krishnaswami
Apr 10, 2018
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Influential Citations
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Quality indicators
Journal
Neurology
Abstract
Objective: To characterize the TOZ-PD study population. Background: Many patients with Parkinson’s disease (PD) continue to experience motor fluctuations despite treatment with available drugs. Tozadenant, an adenosine A 2A receptor antagonist, is an investigational agent that improved motor function in animal models of PD.1 Tozadenant at doses of 120-mg or 180-mg BID was generally well tolerated and reduced OFF time when administered as an adjunct to levodopa in PD patients.2 Tozadenant 60-mg BID and 120-mg BID doses are currently being investigated in a phase 3 clinical study (TOZ-PD). Design/Methods: TOZ-PD is an ongoing, multicenter, multinational, phase 3 study designed to evaluate the efficacy and safety of tozadenant in PD patients taking levodopa (≥2.5 hours OFF time/day, ≥4 doses of levodopa/day, ≥1 concomitant PD medication) experiencing motor fluctuations. TOZ-PD consists of 2 parts: a 24-week double-blind phase (eligible subjects randomized 1:1:1 to tozadenant 60-mg BID, 120-mg BID, or placebo) followed by a 52-week open-label phase (tozadenant 120-mg BID). The primary endpoint is OFF time (as measured by Hauser patient diary). Key secondary endpoints include ON time without troublesome dyskinesia, and changes in UPDRS Parts II (activities of daily living subscale) + III (motor subscale). Results: 449 subjects have been enrolled and randomized; mean age 64.5 years (range: 35–80), 67% male. Mean duration of PD from diagnosis was 9.2 years (range: 3–24) and the mean duration of levodopa treatment was 7.2 years. At baseline, mean daily OFF time while awake was 6.2 hours (range: 2.5–14.0). Conclusions: The characteristics of the TOZ-PD study population are comparable with the tozadenant phase 2b study population and with other previously completed motor fluctuation studies. The study presents an opportunity to evaluate the potential impact of an investigational therapy for PD patients. Study Supported by: Acorda Therapeutics, Inc. Disclosure: Dr. Kieburtz has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Research grants from the National Institutes of Health, the Michael J. Fox Foundation, Medivation, and Neurosearch. Consultant to the United States Food and Drug Administration, Veterans Administration, and National Institutes of Health, AbbVie, Acorda, A. Dr. Olanow has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consultant to AbbVie, Addex, Lundbeck, Newron, Novartis, Teva, and Zambon. Owns stock in Clintrex which provides consulting services for Acorda, AstraZeneca,Biotie, Cynapsus, EMD Serono, Dart Neuroscience, Jazz, Knopp, Kyowa Kirin, Lundbeck, Melior Discov. Dr. Krishnaswami has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee and stockholder of Acorda Therapeutics, Inc. Dr. Resburg has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee and stockholder of Acorda Therapeutics, Inc. Dr. Kerwood has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee and stockholder of Acorda Therapeutics, Inc. Dr. Glass has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee and stockholder of Acorda Therapeutics, Inc. Dr. Kenney has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee and stockholder of Acorda Therapeutics, Inc.