BlepharospasmNCT01686061
Blepharospasm Patient Survey for Patients With Blepharospasm
An observational study of Blepharospasm, run by Merz Pharmaceuticals GmbH at 5 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Blepharospasm
- How many people
- 124 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2012to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA or onabotulinumtoxinA treatment.
Who may be able to join
- Male or female subject aged > 18 years and < 81 years
- Documented clinical diagnosis of blepharospasm
- Currently receiving incobotulinumtoxinA, abobotulinumtoxinA or onabotulinumtoxinA
Who cannot join
- Previous treatment with rimabotulinumtoxinB in the last 2 treatment cycles
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Merz Investigative Site # 0001
Boston, Massachusetts, 02111
Merz Investigative Site # 0006
Columbus, Ohio, 43215
Merz Investigative Site #003
Durham, North Carolina, 27710
Merz Investigative Site #0007
Fountain Valley, California, 92708
Merz Investigative Site # 0002
Sarasota, Florida, 34239
About this study
Official title: 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.
Read the detailed description
This study is open to males and females > 18 years and < 81 years with a clinical diagnosis of blepharospasm.
- Conditions
- Blepharospasm
- Being tested
- No intervention- only one time survey
- Medical subject headings
- Blepharospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention- only one time surveyOther
| Study group | Role | What they receive |
|---|---|---|
| Blepharospasm Survey Group | Not described Receives: Other: No intervention- only one time survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: This is a single, structured interview about experiences with Botulinum Toxins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharospasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merz North America, Inc.
- Responsible party
- Sponsor
- Investigators
- Micki Seoane, Study director, Merz Pharmaceutical, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686061
- Sponsor's protocol ID
- MUS6020100920
- Status last verified
- Apr 2014
- First submitted
- 12 Sep 2012
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blepharospasm Patient Survey: A Structured Interview Evaluating Previous and Current incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA Treatment for Patients With Blepharospasm
- ClinicalTrials.gov ID
- NCT01686061
- Acronym / sponsor ID
- MUS6020100920
- Conditions
- Blepharospasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Merz North America, Inc.
- Study start
- Sep 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 17 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blepharospasm Survey Group | – | Other: No intervention- only one time survey |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA or onabotulinumtoxinA treatment.
Key inclusion criteria (3 listed)
- Male or female subject aged > 18 years and < 81 years
- Documented clinical diagnosis of blepharospasm
- Currently receiving incobotulinumtoxinA, abobotulinumtoxinA or onabotulinumtoxinA
Key exclusion criteria (1 listed)
- Previous treatment with rimabotulinumtoxinB in the last 2 treatment cycles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention- only one time survey | Other | Blepharospasm Survey Group |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Micki Seoane study director
Merz Pharmaceutical, LLC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blepharospasm, run by Merz Pharmaceuticals GmbH at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Botulinum Toxin Treatment Information (time frame: This is a single, structured interview about experiences with Botulinum Toxins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.