This paper describes the development and validation of a migraine-specific quality-of-life instrument that is capable of measuring health-related quality-of-life impairments attributed to migraine. Item selection, item reduction, and pretesting and finalization of items during the instrument development phase resulted in a total of 16 questions which were incorporated into the Migraine-Specific Quality of Life Questionnaire (Version 1:0) (©1992 Glaxo Wellcome Inc). Three meaningful dimensions were hypothesized: Role Function-Restrictive, Role Function-Preventive, and Emotional Function. In the instrument validation phase, the Migraine-Specific Quality of Life Questionnaire was mailed to 1109 migraine patients, providing a response rate of 45% (n=458). Initial psychometric evaluation of the questionnaire indicated that it possessed adequate reliability with Cronbach's alpha for the three dimensions ranging between 0.70 to 0.85. The Migraine-Specific Quality of Life Questionnaire possessed adequate content and criterion validity. All but three items satisfied the test of construct validity. In conclusion, the Migraine-Specific Quality of Life Questionnaire has acceptable psychometric properties and can be used to estimate the effect of migraine and its treatment on the patient's health-related quality of life.