Reliably measured, robust efficacy in Chronic Migraine1-5

8 to 9 fewer headache days per month from baseline at primary time point of week 24 (vs 6 to 7 with placebo)1,2,4

PREEMPT 1

  • 8 to 9 fewer migraine/probable migraine days per month at 24 weeks (vs 6 to 7 with placebo)
  • Week 4 was the first prespecified efficacy evaluation time point; primary end point was measured at 24 weeks

PREEMPT = Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy.

8 to 9 fewer headache days per month from baseline at primary time point of week 24 (vs 6 to 7 with placebo)1,3,4

PREEMPT 2

  • 8 to 9 fewer migraine/probable migraine days per month at 24 weeks (vs 6 to 7 with placebo)
  • Week 4 was the first prespecified efficacy evaluation time point; primary end point was measured at 24 weeks

PREEMPT = Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy.

Study design: PREEMPT 1 and 2 were randomized, double-blind, placebo-controlled studies (N = 1384) across 122 sites. Subjects included adult Chronic Migraine patients not using any concurrent headache prophylaxis and, during a 28-day baseline period, had ≥ 15 headache days lasting 4 hours or more, with ≥ 50% being migraine/probable migraine days. Patients were allowed to use acute headache treatments during the study. Primary time point was 24 weeks.1

BOTOX® was evaluated in 2 randomized, double-blind, placebo-controlled studies of adult Chronic Migraine patients1,6

Patient population

N = 1384

Study sites

122

Headache days during 28-day baseline period

≥ 15 lasting 4 hours or more (≥ 50% being migraine/probable migraine days)

Concurrent headache prophylaxis

Not allowed

Acute headache treatments

Allowed

Primary end point

Mean change from baseline in frequency of headache days at 24 weeks (2 treatment cycles)

REDUCTION FROM BASELINE IN HEADACHE DAYS/MONTH

≥ 50% reduction from baseline in headache days/month at week 247,8

Responder rate data based on “Other” end point in PREEMPT clinical trials

Significant difference in BOTOX® vs placebo in PREEMPT 2 but not PREEMPT 1

REDUCTION FROM BASELINE IN HEADACHE DAYS/MONTH

≥ 75% reduction from baseline in headache days/month at week 247,8

Responder rate data based on “Other” end point in PREEMPT clinical trials

HIT-6™ results in PREEMPT

Proportion of patients with severe HIT-6TM* category scores at week 242,3,†

*HIT-6TM: Headache Impact Test-6.

Total scores range from 36 (no impact) to 78 (severe impact); scores from 60 to 78 indicate severe impact.

Long-term efficacy and safety results from the 2-year, open-label COMPEL trial

Efficacy consistent with PREEMPT trials over 108 weeks and up to 9 treatments5,9,10

  • 8.0, 10.0, 10.5, and 11.6 fewer headache days per month from baseline at weeks 24, 60, 84, and 108, respectively
  • Data from the subgroup of patients who did not use an oral preventive medication anytime during the study are presented (n = 340)
  • This nonrandomized, 2-year, open-label study:
    • Has potential for bias due to no placebo or active comparator arm and low persistency rates given the duration
    • Considered the established efficacy and safety of BOTOX® for Chronic Migraine and determined that it was most appropriate to avoid giving patients placebo for the study duration because of the debilitating impact of the disease
  • Adverse events from the COMPEL trial were consistent with those from the PREEMPT trials

Study design: Open-label study (n = 716) in which enrolled patients received 155 units of BOTOX® (31 sites in a fixed-site, fixed-dose paradigm across 7 head/neck muscles over 12 weeks for 9 treatment cycles [108 weeks]). The primary end point was headache-day reduction at week 108. 56% of patients enrolled received all 9 treatments, and 52% received all study treatments and attended the final follow-up visit.

COMPEL = Chronic Migraine OnabotulinuMtoxinA Prolonged Efficacy open Label.

Access a proven Chronic Migraine preventive treatment, sooner

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