OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial

This study investigates the effectiveness of onabotulinumtoxinA for chronic migraine treatment. It is part of the PREEMPT 1 trial, focused on safety and efficacy. The study lasted 24 weeks and included a placebo-controlled phase. Participants received either onabotulinumtoxinA or a placebo every 12 weeks. The primary measure was the change in headache days per month. Results show that onabotulinumtoxinA significantly reduced headache days compared to placebo. Patients receiving onabotulinumtoxinA reported an average reduction of 9.0 headache days. In contrast, those on placebo showed a 6.7 day reduction. All secondary endpoints also favored onabotulinumtoxinA. The treatment was generally safe, with few adverse events reported. Only 3.5% of patients receiving onabotulinumtoxinA discontinued due to side effects. Overall, findings support onabotulinumtoxinA as an effective migraine prophylaxis option for adults. Clinical relevance: This research confirms that onabotulinumtoxinA is effective for chronic migraine prevention, improving patient outcomes and quality of life.