Abstract Details

Title Istradefylline Effects on Tremor Dominant (TD) and Postural Instability and Gait Difficulty (PIGD) Motor Subtypes

Topic Movement Disorders

Presentation(s) Movement Disorders Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 073

Objective To examine the effect of istradefylline in two distinct motor subtypes, tremor dominant (TD) and postural instability and gait difficulty (PIGD).

Background Istradefylline, a selective adenosine A_2A receptor antagonist, is indicated in the USA and Japan as adjunctive treatment to levodopa/decarboxylase inhibitors in adults with Parkinson’s disease (PD) experiencing OFF time. The TD and PIGD motor subtypes can be differentiated using Unified Parkinson’s Disease Rating Scale (UPDRS) sub-scores for tremor, postural instability, and gait difficulty.

Design/Methods This is a post hoc analysis of pooled data from 6 randomized, placebo-controlled phase 2b/3 pivotal studies, in which patients on baseline anti-PD medications received istradefylline (20 or 40mg/day) or placebo for 12 or 16 weeks. TD subtype was defined by the UPDRS II/III items kinetic and postural tremor in right and left hand and tremor (at rest) of face/lips or chin/arms/legs. PIGD items were freezing, walking, posture, gait, and postural instability. The ratio of mean scores from TD:PIGD items determined subtype (TD [TD:PIGD ratio≥1.5], PIGD [TD:PIGD ratio≤1.0], mixed-type [ratio 1-1.5]).

Results In total, 2284 patients were included (PIGD n=1848, TD n=101, mixed-type n=162, not evaluable n=173). Patients identified as PIGD subtype at baseline showed a significant reduction in UPDRS II/III PIGD total score for istradefylline 40mg/day (least-squares [LS] mean change from baseline [CFB] -0.65) vs placebo (-0.41; difference -0.24, 95% CI [-0.44, -0.04]). Similarly, patients with TD subtype at baseline showed a significant reduction in UPDRS II/III TD total score vs placebo (-1.13) for istradefylline 20mg/day (-3.72; difference -2.60, 95% CI [-4.57, -0.62]) and istradefylline 40mg/day (-2.96; difference -1.83, 95% CI [-3.55, -0.11]).

Conclusions In this analysis of UPDRS-based motor subtypes, istradefylline significantly improved these difficult-to-treat symptoms, although further research is needed to characterize the effects of istradefylline on tremor.

Authors/Disclosures
Fernando L. Pagan, MD, F�鶹��ýӳ�� (Georgetown University Hospital Dept of Neurology) PRESENTER	Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acorda. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Adamas. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merz. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kyowa Kirin. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sunovion. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for US World Meds. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Supernus. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Adamas. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amneal. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sunovion. Dr. Pagan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neurocrine. Dr. Pagan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sunovion. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Supernus. Dr. Pagan has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Journal of Clinical Parkinsonism and related Disorders. Dr. Pagan has stock in Keiferx. The institution of Dr. Pagan has received research support from US World Meds. The institution of Dr. Pagan has received research support from Novartis.
	No disclosure on file
Robert Ristuccia, PhD	No disclosure on file
Akihisa Mori, PhD (SNLD, Ltd.)	Mr. Mori has received personal compensation for serving as an employee of SNLD, Ltd., Japan.
Yasar A. Torres-Yaghi, MD	Dr. Torres-Yaghi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acorda. Dr. Torres-Yaghi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Dr. Torres-Yaghi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal. Dr. Torres-Yaghi has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Abbott. Dr. Torres-Yaghi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Torres-Yaghi has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Dr. Torres-Yaghi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sunovion .

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