Trial Designs for Evaluating Migraine Treatment

Headache intensity rated on a 11-point Numerical Rating Scale (("How intense is your headache right now?"; 0=no pain; 10=worst imaginable pain).

Occurrence of adverse events in each treatment condition recorded by the presence of adverse events ascribed to the treatment, measured using structured prompting (fatigue/drowsiness, nausea/vomiting, altered taste, feeling of warmth, flushing, feeling of cold, heaviness, muscle pain, chest pain/pressure, tingling sensations, dizziness, shortness of breath, or any other adverse event/symptom). For each prompted symptom, participants respond "yes" or "no" and indicate whether they believe the symptom is related to the medication, the migraine attack, or another cause.

PANAS will be used to measure positive and negative emotions or feelings in the present moment. Positive affectivity refers to positive emotions and expressions. Negative affectivity, on the other hand, refers to negative emotions and expressions. This scale consists of words that describe different emotions and is scored on a Likert Scale ranging from 1 to 5 (1= very slightly or not at all, 2 = little, 3 = moderately, 4 = quite a bit and 5 = extremely).

Functional disability due to migraine will be measured on a 4-point scale (0= no disability (i.e., able to function normally); 1=mild disability (i.e., able to perform all activities of daily living but with some difficulty); 2=moderate disability (i.e., unable to perform certain activities of daily living); 3=severe disability (i.e., unable to perform most to all activities of daily living or requiring bed rest)

Use of rescue medication for episodic migraine (type of rescue medications, dose and time of administration) will be noted

Freedom from pain will be measured as yes/no.

Absence of the most bothersome migraine-associated symptoms such as nausea, vomiting, photophobia, and phonophobia. The participants are asked to answer the question by answering yes or no.

Intensity of the experienced adverse events will be measured on a 11-point Numerical Rating Scale (e.g., "To what extent have you been feeling fatigue/dizziness?"; 0=not at all; 10=worst imaginable).

Participants are asked to identify their most bothersome migraine-related symptom other than headache.

Presence of other migraine-related symptoms, including nausea, vomiting, photophobia, phonophobia, or other symptoms is assessed dichotomously (yes/no).

Desire for pain relief is rated on a 11-point NRS ("How strong is your desire for pain relief from the treatment you just received?"; 0 = no desire, 10 = strongest possible desire).

Participants indicate which treatment they believe to have received (sumatriptan or placebo), how certain they are on an 11-point NRS (0 = not at all certain, 10 = completely certain), and the reasons for this response (e.g., adverse events, symptom relief, characteristics of the pill or envelope, or other reasons).

After completion of all six treatment conditions, participants complete a single, retrospective assessment indicating which treatment they preferred overall or whether they perceived no meaningful difference between treatments. Participants are also asked to briefly describe the reasons for their preference.

This parameter is measured as a predictor. Expectations are assessed using two 11-point numerical rating scales (NRSs) measuring expected headache intensity ("How intense do you expect your headache to be in two hours, once the pill has taken effect?"; 0 = no pain, 10 = worst pain imaginable) and expected treatment effect ("How effective do you expect the treatment to be?"; 0 = no treatment effect, 10 = best possible treatment effect)

This parameter is measured as a predictor. Desire for pain relief is rated on a 11-point NRS ("How strong is your desire for pain relief from the treatment you just received?"; 0 = no desire, 10 = strongest possible desire)