Abstract Details

Title A Randomized, Double-blind, Placebo-controlled Pilot Study of Suvorexant for Insomnia in Parkinson Disease

Topic Movement Disorders

Presentation(s) P11 - Poster Session 11 (8:00 AM-9:00 AM)

Poster/Presentation
Number 5-005

Objective To explore safety & efficacy of suvorexant for insomnia in Parkinson disease and to assess viability of a larger study.

Background Parkinson’s disease (PD) has a high prevalence of sleep disorders, including insomnia, yet few studies exist of treatments for insomnia in PD. Suvorexant, an FDA-approved medication for insomnia in the general population, has not previously been studied in this population.

Design/Methods This was a randomized, double-blind, placebo-controlled, crossover trial of suvorexant for insomnia in PD. It involved two 4-week treatment periods separated by a two-week washout period, with suvorexant 10 or 15 mg nightly or a placebo. The primary outcome was change in sleep efficiency, with secondary outcomes that included Wakefulness After Sleep Onset (WASO) and Latency to Persistent Sleep (LPS). Other secondary outcomes included Clinician’s Global Impression of Change (CGI-C); Montreal Cognitive Assessment (MoCA); Insomnia Severity Index (ISI); Epworth Sleepiness Scale (ESS); Beck Depression Inventory (BDI-II); Beck Anxiety Inventory (BAI); and Subject’s Global Impression of Change (SGI-C).

Results In this crossover trial with 21 subjects, suvorexant did not significantly improve sleep efficiency compared to placebo. However, there was a trend with suvorexant towards greater improvement in sleep maintenance (reduced WASO) and in sleep onset (reduced LPS). Additionally, there was significant improvement on the ISI with suvorexant relative to placebo, and a trend favoring suvorexant in CGI-C. Suvorexant was well-tolerated, with no serious or severe adverse events, although two subjects withdrew due to drowsiness. Suvorexant did not worsen cognition, depression, anxiety, or daytime sleepiness.

Conclusions This study is the first randomized trial of suvorexant in patients with Parkinson disease. While it did not meet its primary endpoint, several secondary outcome measures showed a trend favoring suvorexant over placebo. Larger trials in this population are warranted, but recruiting this population for a study requiring multiple overnight polysomnograms proved more difficult than expected.

Authors/Disclosures
Daniel J. Burdick, MD, FAAN (EvergreenHealth Medical Center) PRESENTER	Dr. Burdick has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Praxis Precision Medicines. The institution of Dr. Burdick has received research support from AbbVie. The institution of Dr. Burdick has received research support from Athira. The institution of Dr. Burdick has received research support from Cerevel. The institution of Dr. Burdick has received research support from Merck. The institution of Dr. Burdick has received research support from Neuraly. The institution of Dr. Burdick has received research support from Pharma 2B. The institution of Dr. Burdick has received research support from Jazz Pharmaceuticals. The institution of Dr. Burdick has received research support from Praxis. The institution of Dr. Burdick has received research support from Sage Therapeutics. The institution of Dr. Burdick has received research support from Biogen. The institution of Dr. Burdick has received research support from Cerevance. The institution of Dr. Burdick has received research support from UCB.
Maria G. Cardona-Gonzalez, MD	Dr. Cardona-Gonzalez has nothing to disclose.
Alen Delic	Alen Delic has nothing to disclose.
Raymond D. Park, MD (Evergreen Hospital)	Dr. Park has nothing to disclose.
Pinky H. Agarwal, MD, FAAN (Evergreen Health)	Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Supernus. Dr. Agarwal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acadia Pharmaceuticals Inc. Dr. Agarwal has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neurocrine. Dr. Agarwal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Tanabe Pharma. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Agarwal has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avion Pharmaceuticals. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Acadia. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Supernus. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kyowa Kirin. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amneal. Dr. Agarwal has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie. Dr. Agarwal has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurocrine. Dr. Agarwal has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for AskBio. An immediate family member of Dr. Agarwal has stock in ALDEYRA THERAPEUTICS INC. An immediate family member of Dr. Agarwal has stock in Curis Inc. An immediate family member of Dr. Agarwal has stock in Citius Pharmaceuticals. An immediate family member of Dr. Agarwal has stock in Fortress Biotech. An immediate family member of Dr. Agarwal has stock in TG Therapeutics. An immediate family member of Dr. Agarwal has stock in ATYR PHARMA INC . An immediate family member of Dr. Agarwal has stock in CORVUS PHARMACEUTICALS INC . An immediate family member of Dr. Agarwal has stock in LAVA THERAPEUTICS . An immediate family member of Dr. Agarwal has stock in OVID THERAPEUTICS INC . An immediate family member of Dr. Agarwal has stock in TERNS PHARMACEUTICALS INC. An immediate family member of Dr. Agarwal has stock in VIKING THERAPEUTICS INC. Dr. Agarwal has stock in WAVE LIFE SCIENCES LTD. An immediate family member of Dr. Agarwal has stock in ProQr Therapeutics. An immediate family member of Dr. Agarwal has stock in Mind Medicine. An immediate family member of Dr. Agarwal has stock in Lyra Therapeutics. An immediate family member of Dr. Agarwal has stock in Larimer Therapeutics. An immediate family member of Dr. Agarwal has stock in Lantern Pharma. An immediate family member of Dr. Agarwal has stock in Black Diamond Therapeutics. An immediate family member of Dr. Agarwal has stock in Amylyx Pharma. An immediate family member of Dr. Agarwal has stock in Palisade Bio. An immediate family member of Dr. Agarwal has stock in Inozyme Pharma. An immediate family member of Dr. Agarwal has stock in Pyxis Oncology. An immediate family member of Dr. Agarwal has stock in Vertex Pharmaceuticals. An immediate family member of Dr. Agarwal has stock in Vyne Therapeutics. An immediate family member of Dr. Agarwal has stock in Reviva Pharmaceuticals Hld. An immediate family member of Dr. Agarwal has stock in Immuneering Corp. An immediate family member of Dr. Agarwal has stock in Imunon Inc. An immediate family member of Dr. Agarwal has stock in Enlivex Therapeutics. An immediate family member of Dr. Agarwal has stock in Candel Therapeutics. An immediate family member of Dr. Agarwal has stock in Applied Digital Corp. An immediate family member of Dr. Agarwal has stock in Atai Life Sciences. An immediate family member of Dr. Agarwal has stock in Adma Biologics. The institution of Dr. Agarwal has received research support from Biogen . The institution of Dr. Agarwal has received research support from CHDI Foundation. The institution of Dr. Agarwal has received research support from Eli Lilly. The institution of Dr. Agarwal has received research support from MJ Fox. The institution of Dr. Agarwal has received research support from Roche . The institution of Dr. Agarwal has received research support from Supernus. The institution of Dr. Agarwal has received research support from Nova Nordisc. The institution of Dr. Agarwal has received research support from Inhibikase. The institution of Dr. Agarwal has received research support from Intracellular therapeurtics.

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