Objective:

To analyze within-person consistency of prodrome symptoms in people with migraine. 

Background:

Prodrome is the earliest clinical manifestation of a migraine attack. This analysis of within-participant prodrome symptoms consistency used data from the 60-day screening period of the phase 3 PRODROME trial. 

Design/Methods:

Eligible adult participants who had at least a 1-year history of migraine and experienced 2 to 8 migraine attacks with moderate to severe headache per month in the 3 months prior to screening were included. During the screening period, participants used an e-diary, pre-programmed with each participant’s identified symptoms, to report qualifying prodrome events, defined as prodromal symptoms that the participant confidently believed would be followed by migraine headache within 1-6 hours. The consistency of each prodrome symptom was calculated as the percentage of qualifying prodrome events for each individual associated with a particular symptom among those who had that symptom at least once during the screening period. Population consistency was calculated by averaging across the consistency estimate for each individual with symptom, giving each individual equal weight.

Results:

During the screening period, 920 participants who have entered eDiary data recorded a total of 4802 qualifying prodrome events with a mean of 5.2 events per participant. Approximately 30 distinct prodrome symptoms were reported. There was a high degree of within-person consistency for reported prodrome symptoms across qualifying events. The consistency rates ranged from 46.4% (vomiting, n=6) to 92.5% (neck pain/stiffness, n=414). In addition to neck pain/stiffness, the most consistent prodrome symptoms included feeling tired/sleepy/fatigue (92%, n=494), a “feeling difficult to describe” (90.1%, n=60), sensitivity to light (87.2%, n=605), and cognitive symptoms (85.2%, n=328).

Conclusions:

There is a high degree of within participant consistency of most prodrome symptoms across attacks.