Rationale and design of a prospective study: Cervical Dystonia Patient Registry for Observation of OnaBotulinumtoxinA Efficacy (CD PROBE)
1 Baylor College of Medicine, Department of Neurology, Houston, TX, USA
2 Mayo Clinic, Department of Neurology, Scottsdale, AZ, USA
3 Vanderbilt University Medical Center, Department of Neurology, Nashville, TN, USA
4 Rush University Medical Center, Department of Neurological Sciences, Chicago, IL, USA
5 Duke University Medical Center, Department of Neurology, Durham, NC, USA
6 MedNet Solutions, Inc., Biostatistics, Minnetonka, MN, USA
7 UBC-Envision Group, Scientific Solutions, Philadelphia, PA, USA
8 Allergan, Inc., Global Drug Development, Irvine, CA, USA
9 University of California, School of Medicine, Irvine, CA, USA
10 Allergan, Inc., Medical Affairs, Irvine, CA, USA
11 University of Miami, Miller School of Medicine, Miami, FL, USA
BMC Neurology 2011, 11:140 doi:10.1186/1471-2377-11-140Published: 4 November 2011
A registry of patients with cervical dystonia (
This is a prospective, multicenter, clinical registry in the United States enrolling subjects with cervical dystonia (CD) who are toxin naïve and/or new to the physicians' practices, or who had been in a clinical trial but received their last injection ≥ 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 ± 14.3, age at symptom onset 48.3 ± 16.2, and time to diagnosis 5.4 ± 8.6 years, with an additional 1.0 ± 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.