Blepharospasm Patient Survey for Patients With Blepharospasm

Blepharospasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01686061
• Other study ID #: MUS6020100920
• Status: Completed
• Start date: September 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2014
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 81 Years

Eligibility

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

Related Conditions & MeSH terms

• Blepharospasm

Intervention

Other:
• No intervention- only one time survey

Locations

Country	Name	City	State
United States	Merz Investigative Site # 0001	Boston	Massachusetts
United States	Merz Investigative Site # 0006	Columbus	Ohio
United States	Merz Investigative Site #003	Durham	North Carolina
United States	Merz Investigative Site #0007	Fountain Valley	California
United States	Merz Investigative Site # 0002	Sarasota	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH	Merz North America, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Botulinum Toxin Treatment Information	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