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Abstract Details

Characterizing Within Participant Consistency of Prodromal Symptoms in Migraine: Results from the PRODROME Trial Screening Period
Headache
P8 - Poster Session 8 (8:00 AM-9:00 AM)
12-001
To analyze within-person consistency of prodrome symptoms in people with migraine. 
Prodrome is the earliest clinical manifestation of a migraine attack. This analysis of within-participant prodrome symptoms consistency used data from the 60-day screening period of the phase 3 PRODROME trial. 
Eligible adult participants who had at least a 1-year history of migraine and experienced 2 to 8 migraine attacks with moderate to severe headache per month in the 3 months prior to screening were included. During the screening period, participants used an e-diary, pre-programmed with each participant’s identified symptoms, to report qualifying prodrome events, defined as prodromal symptoms that the participant confidently believed would be followed by migraine headache within 1-6 hours. The consistency of each prodrome symptom was calculated as the percentage of qualifying prodrome events for each individual associated with a particular symptom among those who had that symptom at least once during the screening period. Population consistency was calculated by averaging across the consistency estimate for each individual with symptom, giving each individual equal weight.
During the screening period, 920 participants who have entered eDiary data recorded a total of 4802 qualifying prodrome events with a mean of 5.2 events per participant. Approximately 30 distinct prodrome symptoms were reported. There was a high degree of within-person consistency for reported prodrome symptoms across qualifying events. The consistency rates ranged from 46.4% (vomiting, n=6) to 92.5% (neck pain/stiffness, n=414). In addition to neck pain/stiffness, the most consistent prodrome symptoms included feeling tired/sleepy/fatigue (92%, n=494), a “feeling difficult to describe” (90.1%, n=60), sensitivity to light (87.2%, n=605), and cognitive symptoms (85.2%, n=328).
There is a high degree of within participant consistency of most prodrome symptoms across attacks.
Authors/Disclosures
Todd J. Schwedt, MD, FAAN (Mayo Clinic)
PRESENTER 		Dr. Schwedt has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eli Lilly. Dr. Schwedt has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Schwedt has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Schwedt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Schwedt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Schwedt has received personal compensation in the range of $0-$499 for serving as a Consultant for Amgen. Dr. Schwedt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Scilex. Dr. Schwedt has stock in Aural Analytics. Dr. Schwedt has stock in Nocira. Dr. Schwedt has stock in Allevalux. The institution of Dr. Schwedt has received research support from National Institutes of Health. The institution of Dr. Schwedt has received research support from United States Department of Defense. The institution of Dr. Schwedt has received research support from Patient Centered Outcomes Research Institute. The institution of Dr. Schwedt has received research support from SPARK Neuro. The institution of Dr. Schwedt has received research support from Henry Jackson Foundation. The institution of Dr. Schwedt has received research support from Pfizer. The institution of Dr. Schwedt has received research support from National Headache Foundation. The institution of Dr. Schwedt has received research support from American Heart Association. Dr. Schwedt has received intellectual property interests from a discovery or technology relating to health care. Dr. Schwedt has received intellectual property interests from a discovery or technology relating to health care. Dr. Schwedt has received intellectual property interests from a discovery or technology relating to health care. Dr. Schwedt has received intellectual property interests from a discovery or technology relating to health care. Dr. Schwedt has received publishing royalties from a publication relating to health care.
Andrew M. Blumenfeld, MD, FAAN (Cedars Sinai) Dr. Blumenfeld has received personal compensation for serving as an employee of The Los Angeles Headache Center. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Allergan/Abbvie. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Best Doctors. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Guidepoint. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GLG. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Theranica. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Revance. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Axsome. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Axon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Cedar Sinai. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Revance. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Allergan/Abbvie. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Teva. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for AXSOME.
Logan Roberts, PhD (AbbVie) Dr. Roberts has received personal compensation for serving as an employee of AbbVie. Dr. Roberts has stock in AbbVie.
Yingyi Liu (AbbVie) Yingyi Liu has received personal compensation for serving as an employee of AbbVie.
Elimor Brand-Schieber, PhD (Axovant Gene Therapy) Dr. Brand-Schieber has received personal compensation for serving as an employee of AbbVie. Dr. Brand-Schieber has stock in AbbVie.
Janette Contreras-De Lama Janette Contreras-De Lama has received personal compensation for serving as an employee of AbbVie. Janette Contreras-De Lama has stock in AbbVie.
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.