Abstract Details

Title Safinamide as an Add-On Therapy to a Stable Dose of a Single Dopamine Agonist: Results from a Randomized, Placebo-Controlled, 24-Week Multicenter Trial in Early Idiopathic Parkinson Disease (PD) Patients (MOTION Study)

Topic Movement Disorders

Presentation(s) P01 - (-)

Poster/Presentation
Number 061

Objective

Background Safinamide has previously demonstrated efficacy at doses of 50-100mg/day as add-on therapy to DA-agonist in early PD patients in placebo-controlled trials, and as add-on treatment to levodopa and other PD medications in fluctuating patients.

Design/Methods The MOTION study evaluated the efficacy of the two doses of safinamide compared to placebo on motor symptoms (primary endpoint:UPDRSIII improvement), activities of daily living (ADL), non-motor symptoms and quality of life in early PD patients on optimized doses of a single DA-agonist in a 24-week double-blind, placebo-controlled trial performed in North and South America, Europe, and India. Analyses were hierarchical; if the primary endpoint was not significant for the 100mg/day dose, subsequent endpoint analyses were considered exploratory.

Results 607 (approximately 90%) out of 679 randomized patients completed the 24-week treatment period. Serious AEs were infrequent (<5%) and similar across treatments. Common AEs (?5%) were arthralgia, dizziness, somnolence, headache, nausea, nasopharyngitis, back pain. In patients on monotherapy with a single DA-agonist (666 patients), safinamide 100mg/day significantly improved motor symptoms UPDRSIII (mean change), and PDQ-39 compared to placebo. There was borderline significant improvement in ADL for the 100mg/day as well as UPDRSIII (responders) for the 50mg/day group.

Conclusions Safinamide 100mg/day met the primary objective of significantly improving motor symptoms, quality of life, and borderline significantly ADL, compared to placebo as add-on to a single DA-agonist. These results confirm the efficacy and good tolerability profile of safinamide, already demonstrated in previous studies. Safinamide is a new treatment option for patients with early PD who show signs of loss of benefit on DA-agonist monotherapy.

Authors/Disclosures
Paolo Barone, MD (University of Napoli Dept of Neuroscience) PRESENTER	No disclosure on file
Hubert H. Fernandez, MD, FAAN (Center for Neurological Restoration, Cleveland Clinic)	Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Intrance. Dr. Fernandez has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Fernandez 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. Fernandez has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. Dr. Fernandez has received publishing royalties from a publication relating to health care. Dr. Fernandez has received personal compensation in the range of $10,000-$49,999 for serving as a Steering Committee/Advisory Committee Member with Parkinson Study Group.
	No disclosure on file
Thomas Mueller (St. Josef Hospital)	No disclosure on file
Aksel Siva, MD (Istanbul University Cerrahpasa School of Medicine)	Dr. Siva has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Siva has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Siva has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Siva has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen - TR. Dr. Siva has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Siva has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ali Raif Pharmaceuticals, Turkiye. Dr. Siva has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanovel Pharmaceuticals, Turkiye. Dr. Siva has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Siva has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abdi Ibrahim Ilac - TR. Dr. Siva has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck Serono . The institution of Dr. Siva has received research support from Turkish MS Society. The institution of Dr. Siva has received research support from The Scientific and Technological Research Council Of Turkey - Health Sciences Research Grants.
Marie-Helene Saint-Hilaire, MD, FRCPC, FAAN (Boston University School of Medicine)	Dr. Saint-Hilaire has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Altec. Dr. Saint-Hilaire has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for advarra. Dr. Saint-Hilaire has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Parkinson study group.
Mark Stacy, MD (MUSC Department of Neurology)	Dr. Stacy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biovie. Dr. Stacy has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for National Institute of Aging. Dr. Stacy has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Dartmouth. Dr. Stacy has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Movement Disorders Journal.
Eduardo S. Tolosa, MD	Dr. Tolosa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Prevail. Dr. Tolosa has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MSD . Dr. Tolosa has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Tolosa has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Dr. Tolosa has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for AbbVie . Dr. Tolosa has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Boehringer Ingelheim. Dr. Tolosa has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Ever Neuropharm. Dr. Tolosa has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Esteve. The institution of Dr. Tolosa has received research support from Instituto de Salud CArlos III. Dr. Tolosa has received research support from MJFF. Dr. Tolosa has received publishing royalties from a publication relating to health care.
Ravi Anand	No disclosure on file

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