Treatment of chronic migraine with Botox (onabotulinumtoxinA): Development, insights, and impact.

Chronic migraine (CM) is a neurological disease characterized by frequent migraine attacks that prevent affected individuals from performing daily activities of living, significantly diminish quality of life, and increase familial burden. Before onabotulinumtoxinA was approved for CM, there were few treatment options for these seriously disabled patients and none had regulatory approval. The terminology and recognition of CM evolved in parallel with the onabotulinumtoxinA clinical development program.

Per cent of patients with chronic migraine who responded per onabotulinumtoxinA treatment cycle: PREEMPT.

Objective: The approved use of onabotulinumtoxinA for prophylaxis of headaches in patients with chronic migraine (CM) involves treatment every 12 weeks. It is currently unknown whether patients who fail to respond to the first onabotulinumtoxinA treatment cycle will respond to subsequent treatment cycles. To help inform decisions about treating non-responders, we examined the probability of treatment cycle 1 non-responders responding in cycle 2, and cycle 1 and 2 non-responders responding in cycle 3.

Assessing clinically meaningful treatment effects in controlled trials: chronic migraine as an example.

Unlabelled: In addition to headache, persons with chronic migraine (CM) experience multiple symptoms, both ictal and interictal, that may contribute to their suffering. Translating clinical trial results into practice requires assessment of the results' clinical meaningfulness. When examining treatment benefit in this disabled patient population, multiple headache-symptom measures should be considered to fully reflect clinical relevance.

Development of onabotulinumtoxinA for chronic migraine.

Discovery of the neuromuscular effects of botulinum toxin began in the early 19th century and has continued to evolve. Currently, onabotulinumtoxinA is approved by the U.S.

Improving the classification of migraine subtypes: an empirical approach based on factor mixture models in the American Migraine Prevalence and Prevention (AMPP) Study.

Objectives: Refine the classification of migraine subtypes by applying factor mixture models (FMM) to a large population sample of people with headache.

Background: Current classification of primary headache disorders is symptom-based and uses somewhat arbitrary boundaries developed by expert consensus. Symptom profiles and headache frequency are used to distinguish among probable migraine (PM), episodic migraine (EM), high-frequency episodic migraine (HFEM), and chronic migraine (CM).

OnabotulinumtoxinA for treatment of chronic migraine: PREEMPT 24-week pooled subgroup analysis of patients who had acute headache medication overuse at baseline.

Acute headache medication overuse (MO) is common in patients with chronic migraine (CM). We evaluated safety and efficacy of onabotulinumtoxinA as preventive treatment of headache in CM patients with baseline MO (CM+MO) in a planned secondary analysis from two similarly designed, randomized, placebo-controlled, parallel, Phase III trials. Patients were randomized to treatment groups (155-195 U of onabotulinumtoxinA or placebo) using MO (patient-reported and diary-captured frequency of intake) as a stratifying variable.

Depression and risk of transformation of episodic to chronic migraine.

The aim of this study was to assess the role of depression as a predictor of new onset of chronic migraine (CM) among persons with episodic migraine (EM). The American Migraine Prevalence and Prevention (AMPP) study followed 24,000 persons with severe headache identified in 2004. Using random-effects logistic regression, we modeled the probability that persons with EM in 2005 or 2006 would develop CM in the subsequent year.

Chronic migraine prevalence, disability, and sociodemographic factors: results from the American Migraine Prevalence and Prevention Study.

Objectives: To estimate the prevalence and distribution of chronic migraine (CM) in the US population and compare the age- and sex-specific profiles of headache-related disability in persons with CM and episodic migraine.

Background: Global estimates of CM prevalence using various definitions typically range from 1.4% to 2.

Relationship between disability and health-related quality of life and caregiver burden in patients with upper limb poststroke spasticity.

Objective: To evaluate the relationship between disability and both health-related quality of life (HRQoL) and caregiver burden in patients with upper limb poststroke spasticity.

Design: Multicenter open-label study.

Setting: Thirty-five sites in North America.

OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program.

Objective: To evaluate safety and efficacy of onabotulinumtoxinA (BOTOX(®) ) as headache prophylaxis in adults with chronic migraine.

Background: Chronic migraine is a prevalent, disabling, and undertreated neurological disorder. OnabotulinumtoxinA is the only approved prophylactic therapy in this highly disabled patient population.

Prevalence and burden of chronic migraine in adolescents: results of the chronic daily headache in adolescents study (C-dAS).

Objective: To estimate the prevalence of chronic migraine (CM) among adolescents and to describe the epidemiologic profile, headache characteristics, disability, and healthcare utilization of adolescents with CM in the USA.

Background: Chronic daily headache (CDH) and CM occur in children and adolescents, but are poorly understood in these populations because their presentation is different from that in adults. It may be difficult to assign a definitive diagnosis to young people suffering from CDH because symptoms may fail to meet the criteria for one of the CDH subtypes.

Method of injection of onabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program.

Chronic migraine (CM) is a prevalent and disabling neurological disorder. Few prophylactic treatments for CM have been investigated. OnabotulinumtoxinA, which inhibits the release of nociceptive mediators, such as glutamate, substance P, and calcitonin gene-related peptide, has been evaluated in randomized, placebo-controlled studies for the preventive treatment of a variety of headache disorders, including CM.

OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program.

Objective: To assess the efficacy, safety, and tolerability of onabotulinumtoxinA (BOTOX) as headache prophylaxis in adults with chronic migraine.

Background: Chronic migraine is a prevalent, disabling, and undertreated neurological disorder. Few preventive treatments have been investigated and none is specifically indicated for chronic migraine.

Formation of neutralizing antibodies in patients receiving botulinum toxin type A for treatment of poststroke spasticity: a pooled-data analysis of three clinical trials.

Objective: The purpose of this study was to investigate the incidence of neutralizing antibody (NAb) formation in patients with poststroke spasticity treated with a specific formulation of botulinum toxin type A (BoNTA).

Methods: Data from 3 previous clinical trials of BoNTA in patients with upper and/or lower limb spasticity were pooled and evaluated. Study 1 was a randomized, double-blind, placebo-controlled, multicenter trial of BoNTA in patients aged >/=21 years who had experienced a stroke >6 months before the initiation of the study.

Pooled analysis of the safety of botulinum toxin type A in the treatment of poststroke spasticity.

Objective: To examine the safety of botulinum toxin type A (BTX-A).

Design: Analysis of pooled data of 9 double-blind, placebo-controlled studies of patients with spasticity after stroke.

Setting: University hospitals and specialty rehabilitation centers in the United States.

Botulinum toxin type A for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo-controlled trial.

Objectives: To identify a treatment-responsive population for botulinum toxin type A (BoNTA) and to evaluate the safety and efficacy of 3 different doses of BoNTA as prophylactic treatment of chronic daily headache (CDH).

Patients And Methods: A randomized, double-blind, placebo-controlled study of BoNTA in patients with CDH was conducted from July 6, 2001, through November 7, 2003, at 28 North American study centers. Eligible patients were injected with BoNTA at 225 U, 150 U, 75 U, or placebo and returned for additional masked treatments at day 90 and day 180.