Abstract Details

Title Characterizing Prodrome (Premonitory Phase) in Migraine: Results From the PRODROME Trial Screening Period

Topic Headache

Presentation(s) S41 - Emergent Sciences and Top Headache Research (5:06 PM-5:18 PM)

Poster/Presentation
Number 009

Background The PRODROME trial assessed the efficacy, safety, and tolerability of ubrogepant vs placebo in preventing the onset of moderate or severe headache when administered during the prodrome. The screening period was used to characterize prodromal symptoms and identify eligible participants.

Objective Characterize prodromal (premonitory) symptoms and time to onset of headache in people with migraine who stated they could identify attacks with prodromal symptoms reliably followed by headache.

Design/Methods

The PRODROME (NCT04492020) trial enrolled adults with 2-8 migraine attacks per month who stated that they could identify migraine attacks with prodromal symptoms reliably followed by headache. Using an e-diary, participants reported “qualifying prodrome events,” defined as a migraine attack with prodromal symptoms in which the participant was confident a headache would follow within 1-6 hours. Here, we report the common prodromal symptoms, the proportion of qualifying prodrome events followed by a headache, time to onset of headache, and the percentage of participants who identified prodromal symptoms that were followed by headache ≥75% of the time.

Results A total of 920 participants entered e-diary data, with a mean (median) of 5.2 (5.0) qualifying prodrome events reported per participant. Of 4802 qualifying prodrome events, the most common symptoms were sensitivity to light (57.2%), fatigue (50.1%), neck pain (41.9%), sensitivity to sound (33.9%), and dizziness (27.8%). The majority (95.1%) of qualifying prodrome events were followed by a headache within 24 hours; 90.5% were followed by a headache within 6 hours; and 81.5% within 1-6 hours. For each participant, a mean (median) of 84.4% (100%) of their qualifying prodrome events were followed by a headache within 1-6 hours, with 76.9% of participants identifying qualifying prodrome events that were followed by headache within 1-6 hours ≥75% of the time.

Conclusions Participants were able to identify migraine attacks in which prodromal symptoms were reliably followed by headache within 1-6 hours.

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 Allergan. Dr. Schwedt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Schwedt has received personal compensation in the range of $10,000-$49,999 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 $500-$4,999 for serving as a Consultant for Satsuma. Dr. Schwedt has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biodelivery Science. 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 Axsome. Dr. Schwedt has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Collegium. Dr. Schwedt has received personal compensation in the range of $5,000-$9,999 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. The institution of Dr. Schwedt has received research support from Amgen. 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. 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.
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 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 stock in Biohaven. Dr. Lipton has stock in Manistee. Dr. Lipton has stock in Axon. Dr. Lipton has 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.
Peter Goadsby, MD, PhD, FRS (University of California, Los Angeles)	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 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 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.
Chia-Chun Chiang, MD (Mayo Clinic)	Dr. Chiang has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Chiang has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aruene Corporation . The institution of Dr. Chiang has received research support from American Heart Association.
Brad C. Klein, MD, MBA, FAAN (Abington Neurological Associates, Ltd.)	Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly and Company. Dr. Klein has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ipsen. Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Klein has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Klein has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen. Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Dr. Klein has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for AbbVie. Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Eli Lilly and Company. Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biohaven. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Impel. Dr. Klein has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biodelivery Science. The institution of Dr. Klein has received research support from AbbVie. Dr. Klein has received personal compensation in the range of $500-$4,999 for serving as a Shareholder with AppsbyDocs, LLC. Dr. Klein has a non-compensated relationship as a Chair, Practice Management Committee with American Headache Society that is relevant to AAN interests or activities.
	No disclosure on file
	No disclosure on file
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Michelle Finnegan	Michelle Finnegan has received personal compensation for serving as an employee of AbbVie.
Joel M. Trugman, MD, FAAN	Dr. Trugman has received personal compensation for serving as an employee of AbbVie. Dr. Trugman has stock in AbbVie.