Abstract Details

Title A Novel Approach to Defining Success in the Acute Treatment of Migraine: Demonstrating Therapeutic Benefit at 1-Hour Post-Dose in the Pooled ACHIEVE I and ACHIEVE II Trials

Topic Headache

Presentation(s) P14 - Poster Session 14 (11:45 AM-12:45 PM)

Poster/Presentation
Number 15-002

Objective To evaluate an alternative method of characterizing early treatment success (1-hour post-dose) in clinical trials for the acute treatment of migraine.

Background Migraine attacks include symptoms of head pain, associated symptoms, and functional disability in various combinations. Combining these features as a single endpoint better aligns with the conceptual model of the disease as a symptom complex and may improve the measurement of treatment effects. By characterizing early treatment success (1-hour post-dose) in acute treatment of migraine trials, treatment success findings may be extended from 2-hour post-dose to this earlier timepoint.

Design/Methods Pooled data for placebo and ubrogepant 50mg (ACHIEVE I and ACHIEVE II trials) and data for ubrogepant 100mg (ACHIEVE I) were used for this analysis. To define treatment success, we used confirmatory latent class modeling (LCM) that included inputs at baseline and 1 hour for pain severity and functional disability, and binary measures of nausea, photophobia, and phonophobia. Treatment success rates and predictive validity (using satisfaction with study medications [SWSM] 24-hours post-dose) with LCM were compared with 1-hour pain freedom (1hPF).

Results Treatment success rates based on LCM were 34.3% for ubrogepant 50mg, 34.2% for ubrogepant 100mg, and 25.9% for placebo, yielding a placebo-corrected difference of 8.4% (P<0.001) for the 50mg dose and 8.3% (P<0.001) for the 100mg dose. In comparison, the 1hPF endpoint estimated very low rates with no differences between active treatment and placebo. Using SWSM as the gold standard, sensitivity (0.46 vs 0.07) and Youden’s index (0.26 vs 0.06) were higher for LCM than for 1hPF.

Conclusions The LCM approach was a more sensitive predictor of treatment satisfaction at 24 hours and better aligned with our clinical understanding of migraine as a symptom complex. Compared with LCM, 1hPF failed to capture a substantial proportion of people satisfied with treatment.

Authors/Disclosures
Aubrey Adams, PhD PRESENTER	Dr. Manack Adams has received personal compensation for serving as an employee of Abbvie. Dr. Manack Adams has stock in Abbvie.
Charles Iaconangelo, PhD (Pharmerit)	Dr. Iaconangelo has received personal compensation for serving as an employee of Open Health Group.
	No disclosure on file
Joel M. Trugman, MD, FAAN	Dr. Trugman has received personal compensation for serving as an employee of AbbVie. Dr. Trugman 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.

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