Academic Journals Database
Disseminating quality controlled scientific knowledge

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

ADD TO MY LIST
 
Author(s): Jankovic Joseph | Adler Charles | Charles P David | Comella Cynthia | Stacy Mark | Schwartz Marc | Sutch Susan | Brin Mitchell | Papapetropoulos Spyridon

Journal: BMC Neurology
ISSN 1471-2377

Volume: 11;
Issue: 1;
Start page: 140;
Date: 2011;
Original page

ABSTRACT
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

Tango Rapperswil
Tango Rapperswil

     Affiliate Program