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Open Access Study protocol

Rationale and design of a prospective study: Cervical Dystonia Patient Registry for Observation of OnaBotulinumtoxinA Efficacy (CD PROBE)

Joseph Jankovic1*, Charles H Adler2, P David Charles3, Cynthia Comella4, Mark Stacy5, Marc Schwartz6, Susan M Sutch7, Mitchell F Brin89 and Spyridon Papapetropoulos1011

Author Affiliations

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

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BMC Neurology 2011, 11:140  doi:10.1186/1471-2377-11-140

Published: 4 November 2011

Abstract

Background

A registry of patients with cervical dystonia (

    C
ervical
    D
ystonia
    P
atient
    R
egistry for
    O
bservation of ona
    B
otulinumtoxinA
    E
fficacy [CD PROBE]) was initiated to capture data regarding physician practices and patient outcomes with onabotulinumtoxinA (BOTOX®, Allergan, Inc., Irvine, CA, USA). Methods and baseline demographics from an interim analysis are provided.

Methods/Design

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.

Discussion

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.

Trial registration

NCT00836017