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

This study is currently recruiting participants.
Verified February 2013 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01655862
First received: July 31, 2012
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

This is an observational study to assess health-related quality of life in patients with cervical dystonia 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:

MedlinePlus related topics: Botox Dystonia
U.S. FDA Resources

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

Criteria

Inclusion Criteria:

  • Diagnosis of cervical dystonia 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
  • Treatment with any botulinum toxin product for a non cervical dystonia condition within 2 months of study start
  Contacts and Locations
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: February 1, 2013
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 May 16, 2013