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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01655862
First received: July 31, 2012
Last updated: January 12, 2016
Last verified: January 2016
  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 ]

Enrollment: 62
Study Start Date: July 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 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   (Child, Adult, Senior)
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

Locations
Canada, Quebec
Chicoutimi, Quebec, Canada, G7H 6B9
Clinique Neuro-Rive Sud
Greenfield Park, Quebec, Canada, J4V 2J2
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Chum-Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Queen Elizabeth Health Centre: Medical Specialist Clinic
Montreal, Quebec, Canada, H4A 3L5
CHU - Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Polyclinique Medicale des Ponts
St-Romuald, Quebec, Canada, G6W 8H1
Canada
CHU de Québec, Hôpital de l'Enfant-Jésus
Quebec, Canada, G1J 1Z4
Centre Medical Le Mesnil
Quebec, Canada, G2K 0H1
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

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: January 12, 2016
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
Botulinum Toxins, Type A
AbobotulinumtoxinA
OnabotulinumtoxinA
IncobotulinumtoxinA
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

ClinicalTrials.gov processed this record on September 26, 2016