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CompletedNCT01655862Updated Mar 30, 2017

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

An observational study in Torticollis, sponsored by Allergan. Completed at 8 sites in Canada. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2017-03-30.

Sponsored by Allergan · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
62
Ages
16 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Torticollis
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In context

Dystonia

319 studies on the registry are indexed under Dystonia; 56 are open to participants now.

This study's enrollment of 62 is close to the median of 60 across 126 observational studies indexed under Dystonia.

Browse Dystonia studies →

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Cervical Dystonia (Dystonie)

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
62 participants (actual)
Patient registry
No

Groups and cohorts

  • OnabotulinumtoxinA

    OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.

    Biological: OnabotulinumtoxinA

Interventions

  • BiologicalOnabotulinumtoxinA

    OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.

    Also known as: botulinum toxin Type A, BOTOX®

06

What researchers measure

Primary outcomes

  1. Change from Baseline in Cervical Dystonia Impact Profile Questionnaire (CDIP-58) Score

    Time frame: Baseline, 96 Weeks

Secondary outcomes

  1. Patient's Global Impression of Change (PGIC) Using a 7-Point Scale

    Time frame: Baseline, 96 Weeks

  2. Work Productivity Assessment Using a 10-Item Questionnaire

    Time frame: 96 Weeks

  3. Change from Baseline in Hospital Anxiety and Depression Scale (HAD) Score

    Time frame: Baseline, 96 Weeks

  4. Reasons for Withdrawal of Treatment

    Time frame: 96 Weeks

07

Study locations

8 sites
  • Clinique Neuro-Rive Sud
    Greenfield Park, Quebec J4V 2J2, Canada
  • Hôpital Maisonneuve-Rosemont
    Montreal, Quebec H1T 2M4, Canada
  • Chum-Notre-Dame
    Montreal, Quebec H2L 4M1, Canada
  • Queen Elizabeth Health Centre: Medical Specialist Clinic
    Montreal, Quebec H4A 3L5, Canada
  • CHU - Sherbrooke
    Sherbrooke, Quebec J1H 5N4, Canada
  • Polyclinique Medicale des Ponts
    St-Romuald, Quebec G6W 8H1, Canada
  • CHU de Québec, Hôpital de l'Enfant-Jésus
    Quebec, G1J 1Z4, Canada
  • Centre Medical Le Mesnil
    Quebec, G2K 0H1, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01655862
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Aug 2, 2012
Start date
Jul 2012
Primary completion
Feb 2017
Completion
Feb 2017
Last update
Mar 30, 2017

Study contacts

Goran Davidovic
study director · Allergan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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