Blepharospasm Patient Survey for Patients With Blepharospasm

October 26, 2022 updated by: Merz Pharmaceuticals GmbH

Blepharospasm Patient Survey: A Structured Interview Evaluating Previous and Current incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA Treatment for Patients With Blepharospasm

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Merz Investigative Site #0007
    • Florida
      • Sarasota, Florida, United States, 34239
        • Merz Investigative Site # 0002
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Merz Investigative Site # 0001
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Merz Investigative Site #003
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Merz Investigative Site # 0006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 81 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Blepharospasm Survey Group
Other: No intervention- only one time survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Botulinum Toxin Treatment Information
Time Frame: This is a single, structured interview about experiences with Botulinum Toxins
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)
This is a single, structured interview about experiences with Botulinum Toxins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merz Pharmaceuticals GmbH

Collaborators

Merz North America, Inc.

Investigators

  • Study Director: Micki Seoane, Merz Pharmaceutical, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

September 14, 2012

First Posted (ESTIMATE)

September 17, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2022

Last Update Submitted That Met QC Criteria

October 26, 2022

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUS6020100920

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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