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Abstract Details

A Novel Approach to Defining Success in the Acute Treatment of Migraine: Pooled Results From the ACHIEVE I and ACHIEVE II Trials
Headache
Headache Posters (7:00 AM-5:00 PM)
111
Migraine is characterized by a symptom complex comprising 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 and may improve the measurement of treatment effects. 
To evaluate an alternative method of characterizing success in acute migraine treatment.

We used a confirmatory latent class model (LCM) approach to define success. Pooled data for placebo and ubrogepant 50 mg from the ACHIEVE I and ACHIEVE II trials and data for ubrogepant 100 mg from ACHIEVE I were used. LCM inputs included baseline and 2-hour data for pain (4-point scale), functional disability (4-point scale), and binary measures for nausea, photophobia, and phonophobia. We assessed the predictive validity of LCM classifications using satisfaction with study medications (SWSM) 24 hours post-dose; results were compared with 2-hour pain freedom (2hPF), a current regulatory endpoint.

The pooled analysis sample included 2247 participants. Treatment success rates based on LCM were 53.2% for ubrogepant 50 mg, 54.9% for ubrogepant 100 mg, and 39.0% for placebo, yielding a placebo-corrected difference of 14.2% (P<0.001) for the 50 mg dose and 15.9% (P<0.001) for the 100 mg dose. The LCM approach estimated higher rates of treatment success and larger placebo-corrected differences than found with 2hPF. Using SWSM as the gold standard, sensitivity and correct classification rates were higher for LCM treatment success than for 2hPF.
The LCM approach yielded greater separation from placebo than the regulatory endpoint, 2hPF; more sensitively predicted treatment satisfaction at 24 hours; and better aligned with our clinical understanding of migraine as a symptom complex. Compared with LCM classifications, the regulatory endpoint of 2hPF failed to capture a substantial proportion of patients satisfied with treatment. 
Authors/Disclosures
Richard B. Lipton, MD, FAAN (Albert Einstein College of Medicine)
PRESENTER
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.
Charles Iaconangelo, PhD (Pharmerit) Dr. Iaconangelo has received personal compensation for serving as an employee of Open Health Group.
Daniel Serrano, PhD (Pharmerit International) Dr. Serrano has nothing to disclose.
Aubrey Adams, PhD Dr. Manack Adams has received personal compensation for serving as an employee of Abbvie. Dr. Manack Adams has stock in 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.