Date: Thursday, June 8, 2017
Session Time: 1:15pm-2:45pm
Location: Exhibit Hall C
Objective: To describe the baseline characteristics of the TOZ-PD study population.
Background: Tozadenant is an adenosine A2A antagonist under investigation as an adjunct to levodopa in patients with Parkinson’s disease (PD) experiencing motor fluctuations. A phase 2b, dose-finding study of tozadenant in levodopa-treated patients with PD showed that compared with placebo, tozadenant 120 mg BID, 180 mg BID, and the combined doses (120 mg BID and 180 mg BID) significantly reduced mean daily OFF time by 1.1–1.2 h.1 Based on the tolerability profile, tozadenant 60 mg BID and 120 mg BID doses are currently being investigated in a phase 3 clinical study (TOZ-PD). Here, we describe the baseline characteristics of a TOZ-PD partial cohort, which includes 264 of the total 450 subjects planned for enrollment.
Methods: TOZ-PD is an ongoing, multicenter, multinational, phase 3 study designed to evaluate the efficacy and safety of tozadenant in levodopa-treated patients with PD experiencing motor fluctuations. The study plans to enroll 450 patients randomized 1:1:1 to receive tozadenant 60 mg BID, 120 mg BID, or placebo for 24 weeks, followed by a 52-week open-label period. The primary endpoint is OFF time, as documented by patient diary. Key secondary endpoints include ON time without troublesome dyskinesia. TOZ-PD has been granted a Special Protocol Assessment agreement by the FDA.
Two hundred and sixty-four subjects have been enrolled and randomized; mean age 65 years (range: 35–80), 67% male, 98% Caucasian. Mean duration of PD from diagnosis was 9.3 years (range: 3–24), and on average, subjects were on levodopa treatment for 7.1 years. At baseline, mean daily OFF time while awake was 6.1 hours.
Conclusions: The baseline characteristics of the TOZ-PD partial study population are comparable with the tozadenant phase 2b study population and with other previously completed motor fluctuation studies.1,2
References: 1. Hauser RA, Olanow CW, Kieburtz KD, et al. Tozadenant (SYN115) in patients with Parkinson’s disease who have motor fluctuations on levodopa: a phase 2b, double-blind, randomised trial. Lancet Neurol. 2014;13:767-776.
2. Rascol O, Brooks DJ, Melamed E, et al. Rasagiline as an adjunct to levodopa in patients with Parkinson’s disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study): a randomised, double-blind, parallel-group trial. Lancet. 2005;365:947-954.
To cite this abstract in AMA style:K. Kieburtz, W. Olanow, J. Krishnaswami, C. Resburg, F. Kerwood, C. Kenney. Tozadenant phase 3 study (TOZ-PD) in Parkinson’s disease patients with motor fluctuations: baseline characteristics [abstract]. Mov Disord. 2017; 32 (suppl 2). http://www.mdsabstracts.org/abstract/tozadenant-phase-3-study-toz-pd-in-parkinsons-disease-patients-with-motor-fluctuations-baseline-characteristics/. Accessed February 18, 2018.
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