好色先生

好色先生

Explore the latest content from across our publications
Join The AAN

Log In

Forgot Password?
Create New Account

Loading... please wait

Abstract Details

Long-term Effects of Symbravo® (MoSEIC(TM) meloxicam and rizatriptan) on Headache Burden and Quality of Life: Results of the MOVEMENT Trial
Headache
P8 - Poster Session 8 (11:45 AM-12:45 PM)
15-013
To evaluate patient-reported outcomes from the MOVEMENT trial that assessed long-term safety and efficacy of Symbravo® (MoSEICTM meloxicam and rizatriptan) for the acute treatment of migraine. 
Migraine is a disabling neurological disorder, and many patients report persistent functional impairment and reduced quality of life despite acute treatment.  
MOVEMENT was a Phase 3, open-label trial. Participants completed the MOMENTUM or INTERCEPT randomized controlled trials and continued to experience ≥2 migraine attacks/month. Participants could treat ≤10 attacks/month for ≤12 months, with one dose of Symbravo/attack. Patient-reported outcomes included the Migraine Disability Assessment (MIDAS) scale, the Headache Impact Test (HIT-6) and Migraine Specific Quality of Life Questionnaire Version 2.1 (MSQ).   

In the intent-to-treat population (n=704), mean baseline MIDAS total score was 22.5 (severe disability), HIT-6 total score was 64.1 (severe impact), and the MSQ domains of role function-restrictive, role function-preventative, and emotional function were 47.6, 62.2, and 59.0, respectively (higher MSQ scores indicate better health-related quality of life [QoL]). 

With Symbravo, MIDAS scores improved (change from baseline [mean±SD]): -4.5±20.3, -4.1±19.5, -4.5±22.2, and -0.7±27.9, at 3, 6, 9, and 12 months, respectively. HIT-6 scores improved: -1.4±5.3, -1.5±5.6, -1.8±5.7, -2.8±6.5, and -2.9±8.1, at 1, 3, 6, 9, and 12 months, respectively. MSQ domain scores improved: role function-restrictive, 4.9±18.5, 6.0±18.8, 8.3±20.5, 9.6±20.1, and 10.7±24.0 at 1, 3, 6, 9, and 12 months, respectively; role function-preventive, 3.4±20.0, 5.9±20.4, 7.1±20.4, 9.2±20.8, and 9.9±22.6 at 1, 3, 6, 9, and 12 months, respectively; and emotional function, 4.7±20.9, 5.9±22.1, 5.9±22.5, 7.9±23.6, and 6.6±25.7 at 1, 3, 6, 9, and 12 months, respectively. 

Symbravo was well-tolerated, with no new safety signals. The most common AEs were nausea (5.7%), vomiting (4.7%), dizziness (3.1%), somnolence (2.8%), diarrhea (2.3%), and upper respiratory tract infection (2%). 
Over a maximum 12-months, open-label Symbravo was well-tolerated and associated with improvements in headache-related disability, headache impact, and QoL.  
Authors/Disclosures
Todd Grinnell
PRESENTER 		Mr. Grinnell has received personal compensation for serving as an employee of Axsome Therapeutics. Mr. Grinnell has stock in Axsome Therapeutics.
Richard B. Lipton, MD, FAAN (Albert Einstein College of Medicine) Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biohaven. Dr. Lipton has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GlaxoSmithKline. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vedanta. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Grifols. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axon. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Satsuma. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cool Tech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BDSI. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clexio. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Lipton has or had stock in Biohaven.Dr. Lipton has or had stock in Manistee.Dr. Lipton has or had stock in Axon.Dr. Lipton has or had stock in CoolTech. The institution of Dr. Lipton has received research support from Teva. The institution of Dr. Lipton has received research support from Amgen. The institution of Dr. Lipton has received research support from Allergan/Abbvie. The institution of Dr. Lipton has received research support from Gammacore. The institution of Dr. Lipton has received research support from Axsome. The institution of Dr. Lipton has received research support from Charleston Labs. The institution of Dr. Lipton has received research support from Eli Lilly. The institution of Dr. Lipton has received research support from Satsuma. The institution of Dr. Lipton has received research support from NIH . The institution of Dr. Lipton has received research support from Veterans Administration. Dr. Lipton has received publishing royalties from a publication relating to health care.
yang zhao, PhD Dr. zhao has received personal compensation for serving as an employee of Axsome. Dr. zhao has stock in Axsome.
Angad Chhabra Angad Chhabra has nothing to disclose.
Graham M. Eglit, PhD Dr. Eglit has received personal compensation for serving as an employee of Axsome Therapeutics Inc. Dr. Eglit has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Developmental Neuropsychology: A Life-Span Developmental Journal. Dr. Eglit has stock in Axsome Therapeutics.