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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00836017
First received: February 2, 2009
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

This study is an observational trial which will measure the efficacy of onabotulinumtoxinA in treating Cervical Dystonia.


Condition Intervention
Cervical Dystonia
Other: No Intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score [ Time Frame: 4-6 weeks after treatment 3 (Up to 104.3 weeks) ] [ Designated as safety issue: No ]
    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:
  • Percentage of Participants With Cervical Dystonia (CD) Severity Mild [ Time Frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Pain Numeric Rating Scale Score [ Time Frame: Baseline, 4-6 weeks after treatment 3 (Up to 104.3 weeks) ] [ Designated as safety issue: No ]
    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.


Enrollment: 1046
Study Start Date: January 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836017

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

No publications provided by Allergan

Additional 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
Study First Received: February 2, 2009
Results First Received: June 19, 2014
Last Updated: June 19, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014