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Abstract Details

Change in Migraine Based on a Patient Global Impression of Change in Participants with Episodic Migraine and Chronic Migraine: Results from 5 Atogepant Clinical Trials
Headache
P8 - Poster Session 8 (5:30 PM-6:30 PM)
12-006
Atogepant is an oral calcitonin gene-related peptide receptor antagonist approved in the US and EU for preventive treatment of migraine. 
To evaluate migraine outcome based on a Patient Global Impression of Change (PGIC) across 5 atogepant trials including participants with episodic migraine (EM) and chronic migraine (CM). 
CGP-MD-01 (EM) was a phase 2b/3, randomized, double-blind, placebo-controlled 12-week trial and 3101-302-002 (EM) was a randomized, open-label, 52-week long-term safety study. ADVANCE (EM), ELEVATE (EM with prior inadequate response to 2–4 oral preventive treatment classes), and PROGRESS (CM) were phase 3, randomized, double-blind, placebo-controlled, 12-week trials. PGIC is a single-item patient-reported questionnaire measuring participants’ impression of overall change in migraine since the first study medication dose. PGIC is an anchor item aiding the interpretation of scores from other patient-reported outcomes and is associated with improvements in efficacy outcomes and treatment continuation. PGIC uses a 7-point scale with responders defined as “much better” or “very much better” and was assessed via eTablet at Week 12, and up to Week 52 in 3101-302-002. Data for atogepant 60 mg once daily (QD) and placebo treatment are presented with nominal P values.
A higher proportion of atogepant-treated participants reported “much better” or “very much better” at Week 12 on PGIC compared with placebo in CGP-MD-01 (70.7% vs 52.0%, odds ratio [OR]: 2.23 [95% CI: 1.40, 3.55]; P=0.0008]), ADVANCE (76.1% vs 46.1%, OR: 3.83 [95% CI: 2.52, 5.84]; P<0.0001]), ELEVATE (70.9% vs 30.9%, OR: 5.48 [95% CI: 3.33, 9.00]; P<0.0001]), and PROGRESS (52.8% vs 35.3%, OR: 2.16 [95% CI: 1.48, 3.15]; P<0.0001]) trials. In 3101-302-002, >75% of atogepant-treated participants reported “much better” or “very much better” at all time points. 
Using PGIC, participants reporting improvement in migraine were substantially higher among EM and CM participants treated with atogepant 60 mg QD across 5 atogepant trials. 
Authors/Disclosures
Peter Goadsby, MD, PhD, FRS (University of California, Los Angeles)
PRESENTER
Dr. Goadsby has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Dr. Goadsby has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli-Lilly. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aurene. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva Pharmaceuticals. Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Pfizer. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CoolTech LLC. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tremeau. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PureTech Health LLC. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vial. Dr. Goadsby has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon Biopharma. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Massachusetts Medical Society. The institution of Dr. Goadsby has received research support from Celgene. The institution of Dr. Goadsby has received research support from NIHR. The institution of Dr. Goadsby has received research support from Kallyope. Dr. Goadsby has received publishing royalties from a publication relating to health care. Dr. Goadsby has received publishing royalties from a publication relating to health care. Dr. Goadsby has a non-compensated relationship as a Trustee with Migraine Trust that is relevant to AAN interests or activities. Dr. Goadsby has a non-compensated relationship as a Trustee with Organisation for Understanding Cluster Headache (UK) that is relevant to AAN interests or activities. Dr. Goadsby has a non-compensated relationship as a Executive roles with American Headache Society that is relevant to AAN interests or activities. Dr. Goadsby has a non-compensated relationship as a Director with American Migraine Foundation that is relevant to AAN interests or activities.
Pranav Gandhi Pranav Gandhi has received personal compensation for serving as an employee of AbbVie. Pranav Gandhi has stock in AbbVie Inc.
Simona Sacco, MD (University of L'Aquila) Prof. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Prof. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Prof. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Prof. Sacco has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan. Prof. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pfizer. Prof. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Prof. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lilly. Prof. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Prof. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Prof. Sacco has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck. Prof. Sacco has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Allergan. Prof. Sacco has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers in Neurology. The institution of Prof. Sacco has received research support from Novartis. Prof. Sacco has a non-compensated relationship as a President elect with European Stroke Organisation that is relevant to AAN interests or activities. Prof. Sacco has a non-compensated relationship as a Second vice President with European Headache Federation that is relevant to AAN interests or activities.
Christopher P. Rhyne, MD (Diamond Headache Clinic) Dr. Rhyne has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie/Allergan. Dr. Rhyne has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie/Allergan. Dr. Rhyne has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Abbvie/Allergan. Dr. Rhyne has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen. Dr. Rhyne has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Dr. Rhyne has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Rhyne has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Lilly. Dr. Rhyne has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Theranica. Dr. Rhyne has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck. Dr. Rhyne has received personal compensation in the range of $5,000-$9,999 for serving as a Speaker with Diamond Headache Clinic Research and Education Foundation. Dr. Rhyne has received personal compensation in the range of $500-$4,999 for serving as a Speaker with National Headache Foundation.
Tanya R. Bilchik, MD (Yale University Department of Neurology) Dr. Bilchik has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for allergan/Abbvie. Dr. Bilchik has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Bilchik has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Bilchik has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for lilly. Dr. Bilchik has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for amgen. Dr. Bilchik has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for impel.
Karen Carr, PhD Dr. Carr has nothing to disclose.
Natty Chalermpalanupap, PhD (AbbVie) Dr. Chalermpalanupap has received personal compensation for serving as an employee of AbbVie. Dr. Chalermpalanupap has stock in AbbVie.
No disclosure on file
Brett Dabruzzo, PharmD (AbbVie Medical Affairs) Dr. Dabruzzo has received personal compensation for serving as an employee of AbbVie. Dr. Dabruzzo has stock in AbbVie.
Stewart J. Tepper, MD (The New England Institute for Neurology and Headache) Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aeon. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aruene. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Atheneum. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axsome Therapeutics. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Becker Pharmaceutical Consulting. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cleaview Healhcare Partners. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CoolTech. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CRG. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Decision Resources. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Defined Health. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for DRG. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ExpertConnect. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for FCB Health. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Fenix. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GLG. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Guidepoint Global. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Health Advances. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Health Science Communications. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HMP Communications. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Impel. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for InteractiveForums. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Keyquest. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Krog and Partners. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for M3 Global Research. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Magnolia Innovation. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MJH Holdings. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurolief. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for P Value Communications. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pain Insights Inc. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Palion Medical. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pulmatrix. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Putnam Associates. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SAI MedPartners. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Slingshot Insights. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Spherix Global Insights. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Strategy Inc. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for System Medical Comm. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Taylor and Francis. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Trinity Partners. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UnityHA. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for XOC. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Click Therapeutics. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Miravo. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurofront Therapeutics. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Rehaler. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Synapse Medical Communications. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alphasights. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Perfood. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for M3 Global Research. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Scilex. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Synapse Medical Communication. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tegus. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ClickTherapeutics. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for CoolTech. Dr. Tepper 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. Tepper 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. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Miravo Healthcare. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pulmatrix. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Satsuma. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Lundbeck. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Pfizer. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Scilex. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a CME Speaker with Diamond Headache Clinic. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME Speaker with Medical Learning Institute Peerview. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME Speaker with Medical Education Speakers Network. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a CME Speaker with Miller Medical Communications. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME Speaker with Physicians' Education Resource. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a CME Speaker with WebMD/Medscape. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME speaker with American Headache Society. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME speaker with Vindico Medical Education. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME speaker with HMP Global. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CMe speaker with Medical Learning Institute Peerview.