OBJECTIVES: Persons with migraine experience a variety of autonomic, cognitive, and sensory symptoms associated with migraine attacks. Allowing the patient to self-identify a most bothersome symptom (MBS) without limitation can provide a unique patient-centered approach for identifying and measuring migraine-associated symptoms that matter most to an individual patient. The objective of this analysis was to assess baseline patient-identified MBSs in patients with chronic migraine (CM) enrolled in the PROMISE-2 trial.

METHODS: PROMISE-2 (NCT02974153) was a double-blind, randomized, placebo-controlled trial evaluating eptinezumab for the preventive treatment of CM. At screening, patients verbally described the MBS associated with their migraine attacks, which was then categorized by the investigator into a predefined list of 8 symptoms or an “Other, Specify” option with free-text description. Symptoms categorized as “other” were recoded to the predefined list or to new symptom classes. Baseline MBSs were pooled across the 3 treatment arms (N=1072).

RESULTS: 59% of patients chose an MBS that corresponded with the predefined list, while 41% specified their own option. Combining the predefined and recoded “other” options, MBSs included light sensitivity (18.7%), nausea/vomiting (together or separately, 15.1%), pain with activity (13.7%), sound sensitivity (7.3%), cognitive disruption (4.1%), fatigue (2.4%), and mood changes (1.5%). Additional items from the “other” list included pain (12.4%) and headache (11.2%), as well as throbbing/pulsation (4.7%), multiple symptoms (2.5%), smell sensitivity (0.9%), vision impact (0.7%), aura (0.7%), and pressure/tightness (0.7%), among others.

CONCLUSIONS: These results demonstrate that migraine is associated with numerous symptoms that are most bothersome to patients, beyond the ICHD-3 diagnostic symptoms. Approximately 25% of the MBSs identified in PROMISE-2 are not included in the ICHD-3 diagnostic classification for migraine. Future efforts should endeavor to capture a broader range of MBSs in individuals with migraine in order to enhance doctor-patient communication and optimize individual treatment goals.