NCT01686061

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

October 28, 2022

Status Verified

April 1, 2014

Enrollment Period

7 months

First QC Date

September 12, 2012

Last Update Submit

October 26, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Blepharospasm Survey Group

Other: No intervention- only one time survey

Interventions

Blepharospasm Survey Group

Eligibility Criteria

Age18 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Previous treatment with rimabotulinumtoxinB in the last 2 treatment cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Merz Investigative Site #0007

Fountain Valley, California, 92708, United States

Location

Merz Investigative Site # 0002

Sarasota, Florida, 34239, United States

Location

Merz Investigative Site # 0001

Boston, Massachusetts, 02111, United States

Location

Merz Investigative Site #003

Durham, North Carolina, 27710, United States

Location

Merz Investigative Site # 0006

Columbus, Ohio, 43215, United States

Location

MeSH Terms

Conditions

Blepharospasm

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Study Officials

  • Micki Seoane

    Merz Pharmaceutical, LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 17, 2012

Study Start

September 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

October 28, 2022

Record last verified: 2014-04

Locations