%0 Journal Article
%T Rationale and design of a prospective study: Cervical Dystonia Patient Registry for Observation of OnaBotulinumtoxinA Efficacy (CD PROBE)
%A Joseph Jankovic
%A Charles H Adler
%A P David Charles
%A Cynthia Comella
%A Mark Stacy
%A Marc Schwartz
%A Susan M Sutch
%A Mitchell F Brin
%A Spyridon Papapetropoulos
%J BMC Neurology
%D 2011
%I BioMed Central
%R 10.1186/1471-2377-11-140
%X This is a prospective, multicenter, clinical registry in the United States enrolling subjects with cervical dystonia (CD) who are toxin na£¿ve and/or new to the physicians' practices, or who had been in a clinical trial but received their last injection ¡Ý 16 weeks prior to enrollment. Subjects are followed over 3 injection cycles of onabotulinumtoxinA, with assessments at time of injection and 4-6 weeks later. Information on physician's practice, patient demographics, CD disease history, duration of treatment intervals and neurotoxin dose, dilution, use of electromyography, and muscles injected are collected. Outcomes are assessed by physicians and subjects using various questionnaires.This ongoing registry includes 609 subjects with the following baseline data: 75.9% female, 93.6% Caucasian, mean age 57.6 ¡À 14.3, age at symptom onset 48.3 ¡À 16.2, and time to diagnosis 5.4 ¡À 8.6 years, with an additional 1.0 ¡À 3.5 years before treatment. Of those employed at the time of diagnosis, 36.6% stopped working as a result of CD. CD PROBE, the largest clinical registry of CD treatment, will provide useful data on current treatment practices with onabotulinumtoxinA, potentially leading to refinements for optimization of outcomes.NCT00836017Cervical dystonia (CD), the most common form of adult-onset focal dystonia, is manifested by sustained, involuntary contractions of the cervical musculature [1]. Patients usually present with pain and postural changes of the neck, often associated with irregular head tremor (dystonic tremor) [2]. Impaired neck mobility, chronic pain, and a reduction in the patient's self-image may adversely impact quality of life and result in disability [3,4].Physicians and patients had few treatment options prior to the introduction of botulinum toxin for CD over a quarter century ago [5]. Supported with evidence from randomized controlled trials and meta-analyses, botulinum toxin has become the treatment of choice for CD [6,7]. An evidence-based review by
%U http://www.biomedcentral.com/1471-2377/11/140