Long-term Effects of Symbravo® (MoSEIC(TM) meloxicam and rizatriptan) on Headache Burden and Quality of Life: Results of the MOVEMENT Trial
Todd Grinnell1, Richard Lipton2, yang zhao1, Angad Chhabra1, Graham Eglit1
1Axsome Therapeutics, Inc., 2Department of Neurology and the Montefiore Headache Center, Albert Einstein College of Medicine
Objective:
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. 
Background:
Migraine is a disabling neurological disorder, and many patients report persistent functional impairment and reduced quality of life despite acute treatment.  
Design/Methods:
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).   
Results:

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%). 

Conclusions:
Over a maximum 12-months, open-label Symbravo was well-tolerated and associated with improvements in headache-related disability, headache impact, and QoL.  
10.1212/WNL.0000000000217212
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