Page 70 - The clinical aspects and management of chronic migraine Judith Anne Pijpers

Chapter 4
Figure 1: Trial profile
Screening
721 patients assessed for eligibility
500 Excluded
Did not meet inclusion criteria
42 Excluded:
36 Declined to participate:
9 refused withdrawal therapy
7 refused Botulinum toxin A treatment
7 preferred the regular withdrawal therapy 5 refused investment of time and effort trial 1 refused due to personal circumstances
6 declined without specification
6 other ongoing protocol 1 misdiagnosed as CM
221 patients eligible
179 patients enrolled and randomized
Baseline
Double – blind
90 received botulinum toxin A
89 received placebo
3 Discontinued
2 Lack of efficacy
1 psychiatric comorbidity
12 weeks
Optional Open label
87 completed
88 completed
31 eligible for open label
56 not eligible for open label
41 eligible for open label
47 not eligible for open label
N = 87
N = 74
N = 71
22 completed
N = 68
49 completed
27 completed
N = 88
N = 78
N = 73
N = 78
46 completed
28 received botulinum toxin A
N=3 N=9
59 received regular care
32 received botulinum toxin A
56 received regular care
24 weeks
Follow-up
24 completed
50 completed
27 completed
51 completed
36 weeks
Follow-up
48 weeks
Follow-up
Analysis
20 completed
90 included in primary analysis 87 included in long term analyses
48 completed
30 completed
89 included in primary analysis 88 included in long term analyses
48 completed
1 Discontinued
1 Lack of efficacy
68
Primary analysis included all participants (intention-to-treat), using outcomes after 12 weeks. Of 90 participants receiving withdrawal and BTA during the double blind phase, 31 still had chronic migraine after 12 weeks, of whom 28 participants received one cycle open label BTA. Accordingly, of 89 participants receiving withdrawal and placebo during the double blind phase, 41 still had chronic migraine, of whom 32 received one cycle open label BTA. Long term analyses, comparing one or two cycles of BTA versus placebo after 12, 24, 36, and 48 weeks, included all participants providing at least one outcome measurement. The open-label results (i.e. outcomes after 24, 36, and 48 weeks) of placebo treated patients receiving open label BTA were set as missing (depicted in grey within dashed boxes). The boxes show the number of participants of whom data was available.