Blepharospasm Patient Survey for Patients With Blepharospasm

Sponsor

Merz North America, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01686061

Collaborator

(none)

124

Enrollment

Locations

Duration (Months)

24.8

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blepharospasm	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.

Study Design

Study Type:

Observational

Actual Enrollment :

124 participants

Official Title:

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

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Blepharospasm Survey Group

Other: No intervention- only one time survey

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 81 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Merz Investigative Site #0007	Fountain Valley	California	United States	92708
2	Merz Investigative Site # 0002	Sarasota	Florida	United States	34239
3	Merz Investigative Site # 0001	Boston	Massachusetts	United States	02111
4	Merz Investigative Site #003	Durham	North Carolina	United States	27710
5	Merz Investigative Site # 0006	Columbus	Ohio	United States	43215

Sponsors and Collaborators

Merz North America, Inc.

Investigators

Study Director: Micki Seoane, Merz Pharmaceutical, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Merz North America, Inc.

ClinicalTrials.gov Identifier:

NCT01686061

Other Study ID Numbers:

MUS6020100920

First Posted:

Sep 17, 2012

Last Update Posted:

Apr 8, 2014

Last Verified:

Apr 1, 2014

Additional relevant MeSH terms:

Blepharospasm

Study Results

No Results Posted as of Apr 8, 2014