Blepharospasm Patient Survey for Patients With Blepharospasm

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01686061
First received: September 12, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

The purpose of this survey is to collect detailed information on patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA, including how often they are treated with botulinum toxin, how long their treatment lasts, how satisfied they are with their treatment, and if there is any improvement in their symptoms with the treatment.


Condition Intervention
Blepharospasm
Other: No intervention- only one time survey

Study Type: Observational
Official Title: Blepharospasm Patient Survey: A Structured Interview Evaluating Previous and Current incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA Treatment for Patients With Blepharospasm

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Botulinum Toxin Treatment Information [ Time Frame: This is a single, structured interview about experiences with Botulinum Toxins ] [ Designated as safety issue: No ]
    The following information for patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA, or onabotulinumtoxinA treatment is collected: (1) botulinum treatment information such as intervals for botulinum injections, physician's rationale for injection interval, overall experience with botulinum toxin injections (onset, maximum effect, decline of effect), current injection cycle experience (current satisfaction, satisfaction at maximum effect, and visual analog scale (VAS) of current health status); and (2) disability status using the Blepharospasm Disability Index (BSDI) and the Jankovic Rating Scale (JRS)


Enrollment: 124
Study Start Date: September 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Blepharospasm Survey Group Other: No intervention- only one time survey

Detailed Description:

This study is open to males and females > 18 years and < 81 years with a clinical diagnosis of blepharospasm.

  Eligibility

Ages Eligible for Study:   18 Years to 81 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA or onabotulinumtoxinA treatment.

Criteria

Inclusion Criteria:

  • Male or female subject aged > 18 years and < 81 years
  • Documented clinical diagnosis of blepharospasm
  • Currently receiving incobotulinumtoxinA, abobotulinumtoxinA or onabotulinumtoxinA

Exclusion Criteria:

  • Previous treatment with rimabotulinumtoxinB in the last 2 treatment cycles
  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: NCT01686061

Locations
United States, California
Merz Investigative Site #0007
Fountain Valley, California, United States, 92708
United States, Florida
Merz Investigative Site # 0002
Sarasota, Florida, United States, 34239
United States, Massachusetts
Merz Investigative Site # 0001
Boston, Massachusetts, United States, 02111
United States, North Carolina
Merz Investigative Site #003
Durham, North Carolina, United States, 27710
United States, Ohio
Merz Investigative Site # 0006
Columbus, Ohio, United States, 43215
Sponsors and Collaborators
Merz Pharmaceuticals, LLC
Investigators
Study Director: Micki Seoane Merz Pharmaceutical, LLC
  More Information

No publications provided

Responsible Party: Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01686061     History of Changes
Other Study ID Numbers: MUS6020100920
Study First Received: September 12, 2012
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Blepharospasm
Eyelid Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 22, 2014