Page 69 - The clinical aspects and management of chronic migraine Judith Anne Pijpers

Withdrawal and botulinum toxin A: a double blind RCT
Procedures
Participants started with a 4-week baseline-assessment period, followed by a 12- week randomised, double-blind, placebo-controlled phase with BTA injections immediately prior to medication withdrawal (Figure 1). After this double- blind phase, patients who had withdrawn from medication but remained to have chronic migraine were offered open-label BTA injections (155 units, one treatment cycle) in addition to standard care regarding acute headache medication (open-label phase). Participants who were not eligible for BTA open label treatment received standard care with acute headache medication and, if needed, prophylactic treatment. Study follow-up visits were planned at weeks 12, 24, 48, with additional clinical visits according to medical need. Participants kept 4-week paper diaries with daily registration of headache characteristics, accompanying symptoms, and use of acute headache medication during the baseline observation period and post treatment weeks 9-12, 21-24, 33-36, and 45-48. The diaries had to be send in every week, to ensure an accurate status. Cross checking of data (entry) was performed both manually in a random manner and electronically with fixed algorithms. Determination of migraine and non- migraine headache on any given calendar day was calculated by an algorithm based on the ICHD criteria. In addition, electronic questionnaires were filled out every 12 weeks regarding quality of life (SF-36 29), headache impact and disability (HIT-6 30, MIDAS 31), depression and anxiety (HADS 32). Adverse events were recorded based on spontaneous reports from participants and upon questioning by the study investigators at day 3 and week 12.
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