10,11,28-30 Results from exploratory studies in patients with chronic daily headache (CDH) suggested efficacy with onabotulinumtoxinA within the CM patient population subset, warranting confirmation and further investigation.10,11,31 Therefore, we designed and conducted 2 large, phase 3 studies

to evaluate the efficacy, safety, and tolerability of onabotulinumtoxinA in adults with CM. A pooled analysis of these 2 Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) studies was performed to examine the durability and precision of the individual study efficacy and tolerability results and, potentially, to provide additional clinically relevant insights. We report herein the pooled results of the randomized, placebo-controlled, double-blind phases of these phase 3 studies. Study Design.— The PREEMPT studies were H 89 molecular weight conducted from January 23, 2006 to July 16, 2008, at 56 North American sites in PREEMPT 1 and from February 7, 2006 to August 11, 2008, at 66 global sites (50 North American and 16 European) in PREEMPT 2. Predefined pooling of PREEMPT 1 and 2 studies was performed to confirm the efficacy, safety, and tolerability of onabotulinumtoxinA for prophylaxis

of headaches selleck products in adults with CM and to provide additional Bay 11-7085 statistical power to identify efficacy, safety, and tolerability results that could be missed if each study were reported only separately. Each

study had a 28-day baseline screening phase (hereafter referred to as baseline) and a 24-week, double-blind phase with 2 injection cycles, followed by a 32-week, open-label phase with 3 injection cycles (Fig. 1). Patients used an interactive voice response system (IVRS) daily telephone diary to record their headache symptoms and acute treatments. Both studies were conducted in accordance with the Declaration of Helsinki ethical principles, Good Clinical Practices, principles of informed consent, and requirements of public registration of clinical trials (ClinicalTrials.gov Identifiers NCT00156910 and NCT00168428). Each investigator obtained approval from an Independent Ethics Committee or a local Institutional Review Board prior to study initiation. Written informed consent was obtained from each randomized patient. Study Patients.— Inclusion and exclusion criteria of the individual PREEMPT studies were the same and are described elsewhere.32,33 Briefly, eligible patients were men or women aged 18-65 years with a history of migraine meeting the diagnostic criteria listed in ICHD-II (2004) Section 1, Migraine,4 with “complicated migraine” excepted.