Characterizing Prodrome (Premonitory Phase) in Migraine: Results From the PRODROME Trial Screening Period
Todd J. Schwedt1, Richard B. Lipton2, Peter J. Goadsby3, Chia-Chun Chiang1, Brad Klein4, Chengcheng Liu5, Sung Yun Yu5, Lawrence Severt5, Michelle Finnegan5, Joel M. Trugman5
1Mayo Clinic, 2Albert Einstein College of Medicine, 3King's College and University of California Los Angeles, 4Thomas Jefferson, 5AbbVie
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.
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.
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.