Rationale and design of a prospective study: <ul>C</ul>ervical <ul>D</ul>ystonia <ul>P</ul>atient <ul>R</ul>egistry for <ul>O</ul>bservation of <ul>O</ul>na<ul>B</ul>otulinumtoxinA <ul>E</ul>fficacy (CD PROBE)

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 onabot...

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Main Authors:	Schwartz Marc, Stacy Mark, Comella Cynthia, Charles P David, Adler Charles H, Jankovic Joseph, Sutch Susan M, Brin Mitchell F, Papapetropoulos Spyridon
Format:	Article
Language:	English
Published:	BMC 2011-11-01
Series:	BMC Neurology
Online Access:	http://www.biomedcentral.com/1471-2377/11/140

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spelling	doaj-93bc4e9ee38047bcb85c495f0ee572ac2020-11-24T20:53:21ZengBMCBMC Neurology1471-23772011-11-0111114010.1186/1471-2377-11-140Rationale and design of a prospective study: <ul>C</ul>ervical <ul>D</ul>ystonia <ul>P</ul>atient <ul>R</ul>egistry for <ul>O</ul>bservation of <ul>O</ul>na<ul>B</ul>otulinumtoxinA <ul>E</ul>fficacy (CD PROBE)Schwartz MarcStacy MarkComella CynthiaCharles P DavidAdler Charles HJankovic JosephSutch Susan MBrin Mitchell FPapapetropoulos Spyridon<p>Abstract</p> <p>Background</p> <p>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<sup>®</sup>, Allergan, Inc., Irvine, CA, USA). Methods and baseline demographics from an interim analysis are provided.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p><a href="http://www.clinicaltrials.gov/ct2/show/NCT00836017">NCT00836017</a></p> http://www.biomedcentral.com/1471-2377/11/140
collection	DOAJ
language	English
format	Article
sources	DOAJ
author	Schwartz Marc Stacy Mark Comella Cynthia Charles P David Adler Charles H Jankovic Joseph Sutch Susan M Brin Mitchell F Papapetropoulos Spyridon
spellingShingle	Schwartz Marc Stacy Mark Comella Cynthia Charles P David Adler Charles H Jankovic Joseph Sutch Susan M Brin Mitchell F Papapetropoulos Spyridon Rationale and design of a prospective study: <ul>C</ul>ervical <ul>D</ul>ystonia <ul>P</ul>atient <ul>R</ul>egistry for <ul>O</ul>bservation of <ul>O</ul>na<ul>B</ul>otulinumtoxinA <ul>E</ul>fficacy (CD PROBE) BMC Neurology
author_facet	Schwartz Marc Stacy Mark Comella Cynthia Charles P David Adler Charles H Jankovic Joseph Sutch Susan M Brin Mitchell F Papapetropoulos Spyridon
author_sort	Schwartz Marc
title	Rationale and design of a prospective study: <ul>C</ul>ervical <ul>D</ul>ystonia <ul>P</ul>atient <ul>R</ul>egistry for <ul>O</ul>bservation of <ul>O</ul>na<ul>B</ul>otulinumtoxinA <ul>E</ul>fficacy (CD PROBE)
title_short	Rationale and design of a prospective study: <ul>C</ul>ervical <ul>D</ul>ystonia <ul>P</ul>atient <ul>R</ul>egistry for <ul>O</ul>bservation of <ul>O</ul>na<ul>B</ul>otulinumtoxinA <ul>E</ul>fficacy (CD PROBE)
title_full	Rationale and design of a prospective study: <ul>C</ul>ervical <ul>D</ul>ystonia <ul>P</ul>atient <ul>R</ul>egistry for <ul>O</ul>bservation of <ul>O</ul>na<ul>B</ul>otulinumtoxinA <ul>E</ul>fficacy (CD PROBE)
title_fullStr	Rationale and design of a prospective study: <ul>C</ul>ervical <ul>D</ul>ystonia <ul>P</ul>atient <ul>R</ul>egistry for <ul>O</ul>bservation of <ul>O</ul>na<ul>B</ul>otulinumtoxinA <ul>E</ul>fficacy (CD PROBE)
title_full_unstemmed	Rationale and design of a prospective study: <ul>C</ul>ervical <ul>D</ul>ystonia <ul>P</ul>atient <ul>R</ul>egistry for <ul>O</ul>bservation of <ul>O</ul>na<ul>B</ul>otulinumtoxinA <ul>E</ul>fficacy (CD PROBE)
title_sort	rationale and design of a prospective study: <ul>c</ul>ervical <ul>d</ul>ystonia <ul>p</ul>atient <ul>r</ul>egistry for <ul>o</ul>bservation of <ul>o</ul>na<ul>b</ul>otulinumtoxina <ul>e</ul>fficacy (cd probe)
publisher	BMC
series	BMC Neurology
issn	1471-2377
publishDate	2011-11-01
description	<p>Abstract</p> <p>Background</p> <p>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<sup>®</sup>, Allergan, Inc., Irvine, CA, USA). Methods and baseline demographics from an interim analysis are provided.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p><a href="http://www.clinicaltrials.gov/ct2/show/NCT00836017">NCT00836017</a></p>
url	http://www.biomedcentral.com/1471-2377/11/140
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Rationale and design of a prospective study: <ul>C</ul>ervical <ul>D</ul>ystonia <ul>P</ul>atient <ul>R</ul>egistry for <ul>O</ul>bservation of <ul>O</ul>na<ul>B</ul>otulinumtoxinA <ul>E</ul>fficacy (CD PROBE)

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