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Table 1 Study objectives for 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

Primary Objective

To assess mean change from baseline in the frequency of headache days per 28-day period at 108 weeks (following 9 treatments) using a patient diary completed via IVRS.

Secondary Objectives

To assess mean change from baseline in the frequency of headache days for the 28-day period ending at 60 weeks (following 5 treatments).

To assess the efficacy of onabotulinumtoxinA treatment for CM in adult patients as measured by the mean change from baseline in total HIT-6 score over a 4-week period at 108 weeks (following 9 treatments) and at 60 weeks (following 5 treatments).

To evaluate the long-term safety and tolerability (9 treatment cycles) of onabotulinumtoxinA for CM in adult patients.

  1. CM = chronic migraine; HIT-6 = Headache Impact Test-6; IVRS = interactive voice response system