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Table 5 Secondary and additional efficacy measures to be collected in COMPEL

From: Unmet clinical needs in chronic migraine: Rationale for study and design of COMPEL, an open-label, multicenter study of the long-term efficacy, safety, and tolerability of onabotulinumtoxinA for headache prophylaxis in adults with chronic migraine

Measure

Description

Headache Impact Test (HIT)-6 [33]

• Measures impact of headache and treatment on individual's functional health and well-being.

• 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress.

Patient Global Assessment of Treatment questionnaire (PGAT)

• Measures impact of treatment on headache symptoms and activities of daily living, including items regarding treatment satisfaction.

Migraine-Specific Quality-of-Life Questionnaire (MSQ) [21]

• Measures health-related quality-of-life impairments attributed to migraine.

• Divided into 3 domains: role function - restrictive (how migraines limit one’s daily social- and work-related activities), role function - preventive (how migraines prevent these activities), and emotional function (assesses the emotions associated with migraines).

Migraine Disability Assessment (MIDAS) questionnaire [34]

• Assesses number of days that migraine prevented/limited activities in past 3 months, including paid work, education, household work, and non-work activities (family, social, and leisure).

Generalized Anxiety Disorder Assessment (GAD-7) [15]

• Measures frequency with which patients have been bothered by 7 symptoms of anxiety over the previous 2 weeks.

Patient Health Questionnaire 9-item depression scale (PHQ-9) [35]

• Measures frequency with which patients have been bothered by 9 symptoms of depressive disorders over the previous 2 weeks.

Pittsburgh Sleep Quality Index (PSQI) [18]

• Measures the quality and patterns of sleep in 7 areas: subjective sleep quality; sleep latency; sleep duration; habitual sleep efficiency; sleep disturbances; use of sleeping medication; and daytime dysfunction over the previous month.

Fatigue Severity Scale (FSS) [19]

• 9-item measure assessing the severity of fatigue and its impact on daily living.

Short Form Health Survey with 36 questions (SF-36) [20]

• Generic, multipurpose 8-scale profile of functional health and well-being scores as well as psychometrically based physical and mental health measures and preference-based health utility index.

Healthcare Resource Utilization (HRU)

• HRU questionnaire data collected include medication use, healthcare visits, hospitalizations, and emergency room visits.

Assessment of Chronic Migraine Impacts (ACM-I)

• 24 questions about effect of migraines on one’s life, including daily activities, feelings, energy levels, household, leisure activities, social activities, and work, over the previous 7 days.

Assessment of Chronic Migraine Symptoms (ACM-S)

• 12 questions about migraine symptoms over the previous 24 hours, as a series of dichotomous yes/no questions and others that are rated on a numeric rating scale of 0 to 10.

  1. COMPEL = Chronic migraine OnabotulinuMtoxinA Prolonged Efficacy open Label study