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Abstract Details

Assessment of the Patient Experience Across All Phases of Migraine
Headache
P12 - Poster Session 12 (12:00 PM-1:00 PM)
7-011
To identify a patient-reported outcome (PRO) measure to fully assess the impact across all phases of migraine, particularly the interictal phase.
Migraine symptoms typically present across five phases: prodrome, aura, headache, postdrome, and the interictal period. While an attack adversely affects a patient’s functioning and health-related quality of life, migraine also impacts patients between attacks. Fit for purpose PROs are required to reliably and sensitively characterize the full impact of migraine on patient lives.
To identify a best fit PRO, a targeted literature review was conducted: one strategy addressed existing prodromal, postdromal, and interictal instruments; the other focused on PROs specific to migraine disease. Selected articles included those describing specific symptoms, impacts, and experiences associated with migraine in adult patients; including articles describing PROs designed to assess prodromal, postdromal, or interictal symptoms and impacts.

A total abstract pool of 123 unique citations was reviewed, yielding 15 full text papers meeting criteria. Seven PROs were identified, four of which were selected for in-depth review, including the Post-Migraine Questionnaire, Migraine Physical Function Impact Diary, Migraine Functional Impact Questionnaire, and the Migraine Interictal Burden Scale. Summary information included a review of both descriptive background and an instrument summary including an evaluation of potential measurement gaps.

Importantly, no individual PRO designed to assess symptoms and impacts across the full continuum of migraine and focusing on interictal phase was identified.
Evaluation of patient perceptions of treatment-related improvements across the migraine experience continuum is needed to fully evaluate treatment benefit. While results of this review identified a comprehensive constellation of symptoms and impacts across the five phases of migraine, it did not identify a single measure that includes assessment of the full patient experience across all phases of migraine that meets the rigor described in the FDA PRO guidance.
Authors/Disclosures
Juliana VanderPluym, MD (Mayo Clinic)
PRESENTER 		Dr. VanderPluym has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Neurology and Neuroscience Reports. The institution of Dr. VanderPluym has received research support from Amgen.
Verena Ramirez Campos, MD (Teva) Dr. Ramirez Campos has received personal compensation for serving as an employee of teva.
No disclosure on file
Joshua M. Cohen, MD No disclosure on file
Sanjay Gandhi, MD (Teva Pharmaceuticals) Dr. Gandhi has received personal compensation for serving as an employee of Teva Pharmaceuticals.
No disclosure on file
No disclosure on file
Carla Demuro No disclosure on file
Richard B. Lipton, MD, FÂ鶹´«Ã½Ó³»­ (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.