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Abstract Details

Impact of AXS-12 on Symptom Severity and Functional Impairment in Narcolepsy: Results From the Phase Three SYMPHONY Trial
Sleep
S3 - Research Advances in Sleep and Clinical Impact (2:24 PM-2:36 PM)
008
To evaluate secondary endpoints assessing symptom severity, mood, and daily functioning, from the Phase 3 Symphony trial of AXS-12 (reboxetine) in narcolepsy type 1 (NT1). 
NT1 is a chronic neurologic condition associated with severe symptom burden, impaired functioning, and reduced quality of life. Comorbid mood disorders, such as anxiety and depression, are also common and can further impact daily life. AXS-12 is a selective norepinephrine reuptake inhibitor and cortical dopamine modulator under investigation for narcolepsy. In the Phase 3 SYMPHONY study, AXS-12 met the primary endpoint, significantly reducing weekly cataplexy attack frequency versus placebo. 
SYMPHONY was a randomized, double-blind, placebo-controlled study in patients with NT1. Participants (15-75 years) were randomized to AXS-12 or placebo for 5 weeks. Secondary endpoints included the Clinical Global Impression of Severity (CGI-S) for narcolepsy, the Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10), and the EuroQol 5-Dimension 5-Level (EQ-5D-5L) anxiety/depression domain. 
Ninety participants were enrolled. Baseline mean (SD) CGI-S for narcolepsy scores were 5.2 (1.0) for AXS-12 and 4.9 (1.0) for placebo. At week 5, AXS-12 significantly improved CGI-S versus placebo (LS mean difference [95% CI]=0.72 [0.29, 1.16]; p=0.001). Baseline mean FOSQ-10 total scores were 11.1 (3.1) for AXS-12 and 11.6 (3.2) for placebo. At Week 5, AXS-12 significantly improved FOSQ-10 score versus placebo (LS mean difference [95% CI]=1.66 [0.51, 2.82]; p=0.005). At baseline, 47.8% of participants in the AXS-12 arm and 45.5% in the placebo arm reported anxiety/depression (EQ-5D-5L); numerically more participants improved ≥1 level with AXS-12 (55.0%) versus placebo (31.6%) at Week 5 (p=0.146).  
AXS-12 demonstrated a reduction in clinical impression of overall narcolepsy symptom severity, functional impairment due to EDS, and improved mood-related symptoms. Combined with prior findings, these results highlight the potential of AXS-12 to address narcolepsy symptoms affecting quality of life and functioning.  
Authors/Disclosures
Michael J. Thorpy, MD (Montefiore Medical Center)
PRESENTER 		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.
Lois Krahn Lois Krahn has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avadel. Lois Krahn has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. Lois Krahn has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for Arizona Medical Board. The institution of Lois Krahn has received research support from Takeda. Lois Krahn has received publishing royalties from a publication relating to health care.
Richard K. Bogan, MD (SleepMed) Dr. Bogan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz Pharmaceutical . Dr. Bogan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Takeda. Dr. Bogan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome . Dr. Bogan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Harmony. Dr. Bogan has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Jazz. Dr. Bogan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Axsome. Dr. Bogan has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for Jazz. The institution of Dr. Bogan has received research support from Jazz Pharmaceuticals. The institution of Dr. Bogan has received research support from Harmony . The institution of Dr. Bogan has received research support from Eisai. The institution of Dr. Bogan has received research support from Avadel. The institution of Dr. Bogan has received research support from Takeda. The institution of Dr. Bogan has received research support from Suven. The institution of Dr. Bogan has received research support from Axsome. The institution of Dr. Bogan has received research support from Merck. The institution of Dr. Bogan has received research support from Liva Nova. The institution of Dr. Bogan has received research support from Nyxoah. Dr. Bogan has received research support from Bayer. Dr. Bogan has received intellectual property interests from a discovery or technology relating to health care.
Bruce C. Corser, MD Dr. Corser has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Axsome. Dr. Corser has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Avadel. The institution of Dr. Corser has received research support from Alkermes, . The institution of Dr. Corser has received research support from Apnimed. The institution of Dr. Corser has received research support from Avadel. The institution of Dr. Corser has received research support from Axsome. The institution of Dr. Corser has received research support from Eisai. The institution of Dr. Corser has received research support from Eli Lilly. The institution of Dr. Corser has received research support from Harmony. The institution of Dr. Corser has received research support from Incannex. The institution of Dr. Corser has received research support from Jazz. The institution of Dr. Corser has received research support from Mineralys. The institution of Dr. Corser has received research support from Suven. The institution of Dr. Corser has received research support from Takeda. The institution of Dr. Corser has received research support from Centessa.
Colin Shapiro Colin Shapiro has nothing to disclose.
Shirley Chen, BS Ms. Chen has nothing to disclose.
Angad Chhabra Angad Chhabra has nothing to disclose.
Eileen Leary, PhD (Axsome Therapeutics) Dr. Leary has received personal compensation for serving as an employee of Centessa Pharmaceuticals. Dr. Leary has received personal compensation for serving as an employee of Axsome Therapeutics. Dr. Leary has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clinical Partners Group. Dr. Leary has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pulse Infoframe. Dr. Leary has or had stock in Jazz Pharmaceuticals.Dr. Leary has or had stock in Axsome Therapeutics.Dr. Leary has or had stock in Centessa Pharmaceuticals.
Herriot Tabuteau (Axsome Therapeutics) Herriot Tabuteau has received personal compensation in the range of $100,000-$499,999 for serving as an officer or member of the Board of Directors for Axsome Therapeutics.