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Abstract Details

Efficacy of Low-sodium Oxybate by Baseline Sleep Inertia in a Phase 3 Clinical Study in Participants with Idiopathic Hypersomnia
Sleep
P10 - Poster Session 10 (11:45 AM-12:45 PM)
9-003
Analyze response to low-sodium oxybate (LXB; Xywav®) by baseline sleep inertia in a phase 3 trial (NCT03533114) in participants with idiopathic hypersomnia.
Sleep inertia (difficulty awakening) is a common, debilitating symptom of idiopathic hypersomnia.

Participants received open-label LXB for 10–14 weeks, followed by a 2-week stable-dose period (SDP). Using the visual analog scale for sleep inertia (VAS-SI), participants rated their difficulty awakening during baseline and SDP on a 100-mm line with anchors at 0 (very easy) and 100 (very difficult). Baseline Idiopathic Hypersomnia Severity Scale (IHSS) item 3 and 4 scores defined sleep inertia categories of severe (≥2, both items), absent (0, both items), and mild (1 on both items, or ≥2 or 0 on 1 item only). Efficacy assessments included Epworth Sleepiness Scale (ESS), IHSS, Clinical Global Impression of Severity (CGIs), and Patient Global Impression of Change (PGIc).
Participants (absent, n=4; mild, n=46; severe, n=59) were mean (SD) 40.8 (13.6) years of age and primarily female (72%). At baseline, mean (SD) ESS scores were similar across baseline sleep inertia groups (absent=16.0 [3.7], mild=15.7 [2.8], severe=16.8 [2.7]), but participants with higher sleep inertia had higher IHSS scores (absent=19.3 [7.5], mild=28.5 [6.2], severe=36.4 [5.4]). Percentages of participants rated severely ill on CGIs were 25.0%, 10.9%, and 28.8% in the absent, mild, and severe groups, respectively. From baseline to end of SDP, mean (SD) ESS (absent=−6.5 [1.0], mild=−9.7 [4.8], severe=−10.8 [4.5]) and IHSS (absent=−6.3 [7.8], mild=−13.4 [8.1], severe=−20.8 [9.3]) scores improved across subgroups; nearly all (99%) participants reported improvement on PGIc. At end of SDP, mean (SD) VAS-SI scores decreased by 2.7 (1.8), 23.5 (20.4), and 33.1 (22.2) in the absent, mild, and severe groups, respectively.
LXB improved sleep inertia, and improved sleepiness and overall idiopathic hypersomnia symptoms regardless of baseline sleep inertia. 
Authors/Disclosures
Marisa Whalen
PRESENTER 		Marisa Whalen has received personal compensation for serving as an employee of Jazz Pharmaceuticals.
Michael J. Thorpy, MD (Montefiore Medical Center) Dr. Thorpy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz. Dr. Thorpy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avadel. Dr. Thorpy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for alkermes. Dr. Thorpy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Harmony. Dr. Thorpy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for centessa. Dr. Thorpy has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome. Dr. Thorpy has received publishing royalties from a publication relating to health care.
Douglas S. Fuller (Jazz Pharmaceuticals) Mr. Fuller has received personal compensation for serving as an employee of Jazz Pharmaceuticals. Mr. Fuller has stock in Jazz Pharmaceuticals.
Wayne Macfadden, MD, PT Dr. Macfadden has received personal compensation for serving as an employee of Jazz pharma. Dr. Macfadden has stock in Jazz pharma.
Yves Dauvilliers, MD, PhD (Hopital Gui De Chaulliac) Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for idorsia. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for JAZZ. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Avadel. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alkermes. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Centessa. Yves Dauvilliers, MD, PhD has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bioprojet. Yves Dauvilliers, MD, PhD 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.