Trial record 3 of 20 for:    Open Studies | "Torticollis"

A Prospective, Observational Study of Patients With Cervical Dystonia (Dystonie) Treated With OnabotulinumtoxinA

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01655862
First received: July 31, 2012
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

This is an observational study to assess health-related quality of life in patients with cervical dystonia (dystonie) treated with OnabotulinumtoxinA per routine clinical practice.


Condition Intervention
Torticollis
Biological: OnabotulinumtoxinA

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:
  • Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score [ Time Frame: Baseline, 96 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient's Global Impression of Change (PGIC) Using a 7-Point Scale [ Time Frame: Baseline, 96 Weeks ] [ Designated as safety issue: No ]
  • Work Productivity Assessment Using a 10-Item Questionnaire [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Hospital Anxiety and Depression Scale (HAD) Score [ Time Frame: Baseline, 96 Weeks ] [ Designated as safety issue: No ]
  • Reasons for Withdrawal of Treatment [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: July 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
OnabotulinumtoxinA
OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.
Biological: OnabotulinumtoxinA
OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.
Other Names:
  • botulinum toxin Type A
  • BOTOX®

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Cervical Dystonia (Dystonie)

Criteria

Inclusion Criteria:

  • Diagnosis of cervical dystonia (dystonie) and able to receive botulinum toxin Type A as deemed medically necessary by the physician

Exclusion Criteria:

  • Participation in a clinical trial for any botulinum toxin indication
  • Planning elective surgery during the observational study period
  • Treatment with any botulinum toxin product for cervical dystonia (dystonie)
  • Treatment with any botulinum toxin product for a non-cervical dystonia (dystonie) condition within 2 months of study start
  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: NCT01655862

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com

Locations
Canada, Quebec
Recruiting
Montreal, Quebec, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01655862     History of Changes
Other Study ID Numbers: CMA-BTX-12-001
Study First Received: July 31, 2012
Last Updated: June 13, 2014
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on August 28, 2014