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CD-PROBE: Cervical Dystonia Patient Registry for the Observation of onabotulinumtoxinA Efficacy

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ClinicalTrials.gov Identifier: NCT00836017
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : July 17, 2014
Last Update Posted : July 17, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is an observational trial which will measure the efficacy of onabotulinumtoxinA in treating Cervical Dystonia.

Condition or disease Intervention/treatment
Cervical Dystonia Other: No Intervention

Study Design

Study Type : Observational
Actual Enrollment : 1046 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : January 2009
Primary Completion Date : August 2013
Study Completion Date : August 2013


Groups and Cohorts

Group/Cohort Intervention/treatment
BOTOX®
Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
Other: No Intervention
No intervention was administered as part of the study.


Outcome Measures

Primary Outcome Measures :
  1. Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score [ Time Frame: 4-6 weeks after treatment 3 (Up to 104.3 weeks) ]
    TWSTRS is an assessment scale used to measure the impact of cervical dystonia on patients. The score is comprised of 3 subscales: Severity, Disability, and Pain, each of which is scored independently. The total of these 3 subscales comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater degree of symptom severity.


Secondary Outcome Measures :
  1. Percentage of Participants With Cervical Dystonia (CD) Severity Mild [ Time Frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) ]
    The physician assessed the patient's severity of CD using a 3-point scale: mild, moderate or severe. The percentage of participants with CD Severity Mild is reported.

  2. Percentage of Participants With Improvement in Clinicians Global Impression of Change [ Time Frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) ]
    The physician evaluated the change in the patient's present condition compared to Baseline using a 7-point scale where: 1= very much improved to 7= very much worse. The percentage of participants where the physician's response was: 1=very much improved, 2=much improved or 3=minimally improved is reported.

  3. Percentage of Participants With Improvement in the Patient Global Impression of Change [ Time Frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) ]
    The patient evaluated the change in their present condition compared to Baseline using a 7-point scale where: 1= very much improved to 7= very much worse. The percentage of participants with responses: 1=very much improved, 2=much improved or 3=minimally improved is reported.

  4. Pain Numeric Rating Scale Score [ Time Frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) ]
    Patients rated their level of pain during the past 24 hours using an 11-point scale where: 0=no pain to 10= pain as bad as you can imagine. A lower number score indicated a lower amount of pain.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Cervical Dystonia whom are being treated with onabotulinumtoxinA
Criteria

Inclusion Criteria:

  • Diagnosed with Cervical Dystonia
  • Candidate for botulinum toxin type A therapy
  • New to physician's practice, and/or new to botulinum toxin type A therapy, or has not been injected with botulinum toxin type A for at least 16 weeks as a participant in another clinical trial investigating botulinum toxin type A for cervical dystonia
  • Able to follow study instructions and complete study activities

Exclusion Criteria:

  • Patients undergoing elective surgery during the trial period
  • Females who are pregnant, nursing, or planning a pregnancy
  • History of poor cooperation or compliance with medical treatment or unreliability
  • Any condition or situation in which, in the investigator's opinion, places the patient at significant risk, could confound the study data, or may interfere with the patient's participation in the study, including but not limited to unstable medical conditions
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836017


Locations
United States, Massachusetts
Springfield, Massachusetts, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00836017     History of Changes
Other Study ID Numbers: MedAff BTX-0718
First Posted: February 4, 2009    Key Record Dates
Results First Posted: July 17, 2014
Last Update Posted: July 17, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents