A Retrospective Chart Review of BOTOX® and Xeomin® for the Treatment of Cervical Dystonia and Blepharospasm

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01814774
First received: March 18, 2013
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of Cervical Dystonia and Blepharospasm in clinical practice.


Condition Intervention
Cervical Dystonia
Blepharospasm
Other: No Intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Dose of Botulinum Toxin Used to Treat Cervical Dystonia [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    The average dose of botulinum toxin received per patient per year was calculated.

  • Dose of Botulinum Toxin Used to Treat Blepharospasm [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    The average dose of botulinum toxin received per patient per year was calculated.


Secondary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    An Adverse Event was any unfavorable and unintended sign, symptom, or disease documented in the medical chart that occurred after treatment with botulinum toxin, or pre-existing conditions that worsened during the retrospective period.

  • Botulinum Toxin Inter-injection Interval [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    Injection-interval was the time in weeks between injections of botulinum toxin.


Enrollment: 48
Study Start Date: January 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
BOTOX®
Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Other: No Intervention
No treatment (intervention) was administered.
Xeomin®
Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
Other: No Intervention
No treatment (intervention) was administered.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants with cervical dystonia or blepharospasm previously treated with Xeomin® and BOTOX®.

Criteria

Inclusion Criteria:

  • confirmed primary diagnosis of idiopathic cervical dystonia or blepharospasm for at least 2 years
  • treatment with Xeomin® and BOTOX® for at least 1 year each

Exclusion Criteria:

  • having a neuromuscular junction transmission disorder or taking any medications that could affect neuromuscular junction transmission
  • previous surgical procedure involving bone or muscle for the management of cervical dystonia or blepharospasm
  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: NCT01814774

Locations
Norway
Bergen, Norway
United Kingdom
Wakefield, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01814774     History of Changes
Other Study ID Numbers: TRU2011
Study First Received: March 18, 2013
Results First Received: June 4, 2014
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board
Norway: Ethics Committee

Additional relevant MeSH terms:
Blepharospasm
Dystonia
Dystonic Disorders
Torticollis
Eyelid Diseases
Eye Diseases
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014