Abstract Details

Title Safety and Efficacy of Solriamfetol for the Treatment of Excessive Daytime Sleepiness in Parkinson’s Disease in a Four-Week Double-blind, Placebo-controlled Randomized Crossover Study

Topic Movement Disorders

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 10-036

Objective To evaluate the safety (primary objective) and efficacy of solriamfetol for the treatment of excessive daytime sleepiness (EDS) in participants with Parkinson’s Disease (PD).

Background EDS affects up to 50% of PD patients. Solriamfetol, a selective dopamine and norepinephrine reuptake inhibitor, significantly reduced EDS in Phase 3 clinical studies of narcolepsy and obstructive sleep apnea patients, and has not been studied in PD.

Design/Methods This is a phase 2 double-blind, placebo-controlled, randomized, crossover clinical trial of participants 35-80 years of age, diagnosed with idiopathic PD according to the UK PDS Brain Bank Criteria, Hoehn and Yahr stage ≤3, on a stable PD treatment regimen, and with an Epworth Sleepiness Scale (ESS) score >10. Participants were randomized (3:3:1) to three sequence groups (A, B, and C) for a four-week treatment period. Participants assigned to sequence A or B received one week of placebo and solriamfetol 75 mg, 150 mg, and 300 mg; those in sequence C received placebo all four weeks. The primary objective of the study was to assess safety and tolerability by adverse events, physical exams, electrocardiograms, laboratory tests, vital signs and Columbia-Suicide Severity Rating Scale (C-SSRS). The key efficacy endpoint was change in ESS score. Exploratory endpoints included MDS-UPDRS Parts III and IV, Global Impression of Change, and scales for apathy, fatigue severity (FSS), and Cognition (SCOPA-Cog).

Results Sixty-six participants were randomized (mean [SD] age, 64.6 [8.5]; 68.2% male). Mean (SD) duration of PD was 6.4 (4.4) years. At baseline, 75.8% of participants were Hoehn and Yahr stage 2 and 19.7% were stage 3, and mean (SD) ESS total score was 16.1 (2.9). Completion of this study occurred in August 2018.

Conclusions Study participants had mild-moderate PD with moderate to severe EDS. Final safety and efficacy data will be available for presentation at the 2019 annual AAN meeting.

Authors/Disclosures
Aleksandar Videnovic, MD, MSc, FAAN (MGH Neurological Clinical Research Institute) PRESENTER	Dr. Videnovic has nothing to disclose.
Amy W. Amara, MD PhD (University of Colorado Anschutz Medical Center)	The institution of Dr. Amara has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Photopharmics, Inc. The institution of Dr. Amara has received research support from Michael J Fox Foundation for Parkinson's Research . The institution of Dr. Amara has received research support from Biogen Idec. The institution of Dr. Amara has received research support from NIH.
Cynthia L. Comella, MD, FAAN (Rush University Medical Center)	Dr. Comella has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ipsen. Dr. Comella has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vima. Dr. Comella has received publishing royalties from a publication relating to health care. Dr. Comella has received publishing royalties from a publication relating to health care.
Paula Schweitzer	No disclosure on file
Helene A. Emsellem, MD (Sleep Health Institute, LLC)	The institution of Dr. Emsellem has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GuidePoint Consulting. The institution of Dr. Emsellem has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda Pharmaceuticals. The institution of Dr. Emsellem has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Harmony Bioscience. The institution of Dr. Emsellem has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Avadel . The institution of Dr. Emsellem has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Philips Respironics. The institution of Dr. Emsellem has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for NLS Pharma. The institution of Dr. Emsellem has received research support from ApniMed. The institution of Dr. Emsellem has received research support from Axsome. The institution of Dr. Emsellem has received research support from Balance. The institution of Dr. Emsellem has received research support from Expansion. The institution of Dr. Emsellem has received research support from Avadel (Flamel). The institution of Dr. Emsellem has received research support from Harmony. The institution of Dr. Emsellem has received research support from Idorsia. The institution of Dr. Emsellem has received research support from Imbrium. The institution of Dr. Emsellem has received research support from Jazz. The institution of Dr. Emsellem has received research support from Merck. The institution of Dr. Emsellem has received research support from NLS. The institution of Dr. Emsellem has received research support from Philips. The institution of Dr. Emsellem has received research support from Suven. The institution of Dr. Emsellem has received research support from Takeda. The institution of Dr. Emsellem has received research support from Vanda.
	No disclosure on file
Amanda Sterkel, PhD	No disclosure on file
Mildred D. Gottwald, PharmD	No disclosure on file
	No disclosure on file
	No disclosure on file
Robert A. Hauser, MD, MBA, FAAN (Movement Disorders Center)	Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Supernus. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Stoparkinson. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Revance. Dr. Hauser has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Abbvie. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neurocrine. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amneal. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Intrance. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zambon. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for NanoPharmasolutions. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HanAll BioPharma. Dr. Hauser has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Cerevance. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Clario. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for ABLi Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sumitomo. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Taurus Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sorriddi Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Contera. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alterity Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Convatec Inc. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Knight Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Acadia. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biorasi. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medicure Pharma. Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BlueRock. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Inhibikase. The institution of Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Stoparkinson. The institution of Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Photopharmics. The institution of Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ABLi Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal . Dr. Hauser has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurocrine Biosciences. Dr. Hauser has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Supernus. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Hauser has or had stock in Inhibikase.Dr. Hauser has or had stock in Axial Therapeutics.Dr. Hauser has or had stock in Enterin.Dr. Hauser has or had stock in Photopharmics. The institution of Dr. Hauser has received research support from Annovis Bio, Inc.. The institution of Dr. Hauser has received research support from Inhibikase Therapeutics. The institution of Dr. Hauser has received research support from AbbVie, Inc.. The institution of Dr. Hauser has received research support from Biogen MA. The institution of Dr. Hauser has received research support from Cavion, Inc.. The institution of Dr. Hauser has received research support from Cerevance Beta, Inc.. The institution of Dr. Hauser has received research support from Cerevel Therapeutics. The institution of Dr. Hauser has received research support from Enterin, Inc.. The institution of Dr. Hauser has received research support from Genentech. The institution of Dr. Hauser has received research support from Global Kinetics Corporation. The institution of Dr. Hauser has received research support from Hoffman-La Roche Inc. The institution of Dr. Hauser has received research support from Michael J. Fox Foundation for Parkinson's Research. The institution of Dr. Hauser has received research support from National Parkinson's Foundation. The institution of Dr. Hauser has received research support from Neuroderm. The institution of Dr. Hauser has received research support from Sage Therapeutics. The institution of Dr. Hauser has received research support from Scion NeuroStim. The institution of Dr. Hauser has received research support from UCB BioPharma. The institution of Dr. Hauser has received research support from UCB. The institution of Dr. Hauser has received research support from Amneal Pharmaceuticals. The institution of Dr. Hauser has received research support from Motric Bio, Inc.. The institution of Dr. Hauser has received research support from Sun Pharma Advanced Research Company. The institution of Dr. Hauser has received research support from Teva Branded Pharmaceuticals. The institution of Dr. Hauser has received research support from Truebinding, Inc.. The institution of Dr. Hauser has received research support from Jazz Pharmaceuticals. The institution of Dr. Hauser has received research support from Ipsen. Dr. Hauser has received intellectual property interests from a discovery or technology relating to health care.

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