Rationale and design of a prospective study

Cervical Dystonia Patient Registry for Observation of OnaBotulinumtoxinA Efficacy (CD PROBE)

Joseph Jankovic, Charles Howard Adler, P. David Charles, Cynthia Comella, Mark Stacy, Marc Schwartz, Susan M. Sutch, Mitchell F. Brin, Spyridon Papapetropoulos

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Background: A registry of patients with cervical dystonia (Cervical Dystonia Patient Registry for Observation of onaBotulinumtoxinA Efficacy [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.

Original languageEnglish (US)
Article number140
JournalBMC Neurology
Volume11
DOIs
StatePublished - Nov 4 2011

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Torticollis
Registries
Observation
Prospective Studies
Physicians
Injections
Demography
Neurotoxins
Electromyography
Therapeutics
onabotulinumtoxinA
Age of Onset
Clinical Trials
Muscles

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Rationale and design of a prospective study : Cervical Dystonia Patient Registry for Observation of OnaBotulinumtoxinA Efficacy (CD PROBE). / Jankovic, Joseph; Adler, Charles Howard; Charles, P. David; Comella, Cynthia; Stacy, Mark; Schwartz, Marc; Sutch, Susan M.; Brin, Mitchell F.; Papapetropoulos, Spyridon.

In: BMC Neurology, Vol. 11, 140, 04.11.2011.

Research output: Contribution to journalArticle

Jankovic, Joseph ; Adler, Charles Howard ; Charles, P. David ; Comella, Cynthia ; Stacy, Mark ; Schwartz, Marc ; Sutch, Susan M. ; Brin, Mitchell F. ; Papapetropoulos, Spyridon. / Rationale and design of a prospective study : Cervical Dystonia Patient Registry for Observation of OnaBotulinumtoxinA Efficacy (CD PROBE). In: BMC Neurology. 2011 ; Vol. 11.
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abstract = "Background: A registry of patients with cervical dystonia (Cervical Dystonia Patient Registry for Observation of onaBotulinumtoxinA Efficacy [CD PROBE]) was initiated to capture data regarding physician practices and patient outcomes with onabotulinumtoxinA (BOTOX{\circledR}, 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 na{\"i}ve 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.",
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