BlepharospasmNCT00210431
Post Marketing Surveillance Study of Dysport
An observational study of Blepharospasm and Hemifacial Spasm, run by Ipsen at 36 sites in 3 countries.
Trial summary
The purpose of this study is to provide further information regarding the risks and benefits of Dysport in marketed indications. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Blepharospasm, Hemifacial Spasm, Cervical Dystonia
- How many people
- 783 participants
- Where
- 36 sitesin 3 countries
- Study dates
- Oct 2004to Jun 2006
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adult or child over the age of 2 years
- scheduled to receive Dysport as per their normal treatment practice, and in conformance with their country's Summary of Product Characteristics
Who cannot join
- history of hypersensitivity to Dysport or drugs with a similar chemical structure
- treatment with any other investigational drug within the last 30 days before survey entry
Trial locations and contacts
36 sites in 3 countries.
36 sites in 3 countries
France17 sites
Centre Hospitalier Saint Esprit
Agen, 47923
Center Hospitalier du Pays d'Aix
Aix-en-Provence, 13616
Centre Hospitalier
Chambéry, 73011
Hopital Timone Adultes
Marseille, 13385
Hopital Central
Nancy, 54035
Hopital Hotel Dieu
Nantes, 44093
Hopital Pasteur
Nice, 06002
Hopital Caremeau
Nîmes, 30029
Hopital Saint Antione
Paris, 75571
Centre Hospitalier Pitie Salpetriere
Paris, 75651
Hopital Sainte Anne
Paris, 75674
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
CHU Charles Nicolle
Rouen, 76031
Hopital Bellevue
Saint-Etienne, 42055
Hopital Civil
Strasbourg, 67091
Hopital Purpan
Toulouse, 31059
Hopital Rangueil
Toulouse, 31059
Russia10 sites
Alma-Ata State Institute of Postgraduate Education
Alma-Ata, Kazakhstan, 480070
Rehabilitation Centre "Balbulak"
Alma-Ata, Kazakhstan
Centre of plastic surgery "Reconstruction and Recreation"
Moscow, 115522
Institute of Medical Aestetic "Vallex-M"
Moscow, 117393
Moscow Medical Academy
Moscow, 119021
Scientific Research Institute of Neurology
Moscow, 123367
Cosmetological Centre "Diamond"
Moscow, 125367
National Medical Centre of Surgery
Moscow, 125367
Federal Centre "Pediatric Rehabilitology"
Moscow, 142031
Centre for Aesthetic Dermatology and Surgery of Russian Academy of Sciences
Moscow
Germany9 sites
Praxis für Neurologie
Berlin, 10178
Rhein. F.-Wilhelms-Universität
Bonn, 53127
Praxis für Neurologie
Giessen, 35390
Städt. Krankenhaus Martha-Maria
Halle-Dölau, 6120
Neurologische Praxis
Hamburg, 20249
Med. Hochschule
Hanover, 30625
Bürgerhospital
Stuttgart, 70191
E.-Karls-Universität
Tübingen, 72076
Klinikum der Stadt Villingen-Schwenningen
Villingen-Schwenningen, 78054
About this study
Official title: A Post Marketing Surveillance Study of Dysport Formulated With a Batch of Bulk Active Substance From a New Primary Manufacturing Facility at the Centre for Applied Microbiology & Research (CAMR)
The purpose of this study is to provide further information regarding the risks and benefits of Dysport in marketed indications.
- Conditions
- Blepharospasm, Hemifacial Spasm, Cervical Dystonia, Spasmodic Torticollis, Cerebral Palsy, Muscle Spasticity
- Medical subject headings
- Blepharospasm, Hemifacial Spasm, Torticollis, Cerebral Palsy, Muscle Spasticity, Stroke, Equinus Deformity
What is being measured
The primary outcome is the main question the study is designed to answer.
- assessment of efficacy as assessed by treating physician at scheduled follow up visit
- data on adverse events since treatment with Dysport
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2004
- Study completionJun 2006
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.
- More trials run by IpsenThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 783 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210431
- Sponsor's protocol ID
- Y-47-52120-093
- Status last verified
- Mar 2020
- First submitted
- 13 Sep 2005
- Last updated
- 31 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Marketing Surveillance Study of Dysport Formulated With a Batch of Bulk Active Substance From a New Primary Manufacturing Facility at the Centre for Applied Microbiology & Research (CAMR)
- ClinicalTrials.gov ID
- NCT00210431
- Acronym / sponsor ID
- Y-47-52120-093
- Conditions
- Blepharospasm, Hemifacial Spasm, Cervical Dystonia, Spasmodic Torticollis, Cerebral Palsy, Muscle Spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 783 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- Jun 2006 (actual)
- First posted
- 21 Sep 2005 (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 study is to provide further information regarding the risks and benefits of Dysport in marketed indications.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- adult or child over the age of 2 years
- scheduled to receive Dysport as per their normal treatment practice, and in conformance with their country's Summary of Product Characteristics
Key exclusion criteria (2 listed)
- history of hypersensitivity to Dysport or drugs with a similar chemical structure
- treatment with any other investigational drug within the last 30 days before survey entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
- assessment of efficacy as assessed by treating physician at scheduled follow up visit
- data on adverse events since treatment with Dysport
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 31 Mar 2020.
Related trials for Blepharospasm
RecruitingPhase 2
DaxibotulinumtoxinA for Blepharospasm
Blepharospasm of Both Eyelids, Blepharospasm of Left Eyelid
RecruitingPhase 4
Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm
Benign Essential Blepharospasm, Hemifacial Spasm
RecruitingObservational study
Brain Networks in Dystonia
Spasmodic Dysphonia, Singer's Dystonia
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.
Ipsen Medical Director study director
Ipsen
36 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blepharospasm and Hemifacial Spasm, run by Ipsen at 36 sites in 3 countries.
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 2 inclusion and 2 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 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in France, Russia, Germany. 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?
- assessment of efficacy as assessed by treating physician at scheduled follow up visit. The study lists 2 primary outcomes in all. 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 31 Mar 2020.