Blepharospasm Patient Survey for Patients With Blepharospasm

Completed

• Conditions: Blepharospasm
• Interventions: Other: No intervention- only one time survey

• Registration Number: NCT01686061
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-14
• Study First Posted: 2012-09-17
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2014-04
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

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

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Exclusion Criteria

• Previous treatment with rimabotulinumtoxinB in the last 2 treatment cycles

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Blepharospasm Survey Group	No intervention- only one time survey	-

Primary Outcome Measures

Name	Time	Method
Botulinum Toxin Treatment Information	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)

Trial Locations

Locations (5)

Merz Investigative Site #0007; 🇺🇸 Fountain Valley, California, United States

Merz Investigative Site # 0002; 🇺🇸 Sarasota, Florida, United States

Merz Investigative Site # 0006; 🇺🇸 Columbus, Ohio, United States

Merz Investigative Site # 0001; 🇺🇸 Boston, Massachusetts, United States

Merz Investigative Site #003; 🇺🇸 Durham, North Carolina, United States