Post Marketing Surveillance Study of Dysport

March 30, 2020 updated by: Ipsen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
783

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France, 47923
        • Centre Hospitalier Saint Esprit
      • Aix en Provence, France, 13616
        • Center Hospitalier du Pays d'Aix
      • Chambery, France, 73011
        • Centre Hospitalier
      • Marseille, France, 13385
        • Hopital Timone Adultes
      • Nancy, France, 54035
        • Hôpital Central
      • Nantes, France, 44093
        • Hopital Hotel Dieu
      • Nice, France, 06002
        • Hôpital Pasteur
      • Nimes, France, 30029
        • Hopital Caremeau
      • Paris, France, 75674
        • Hôpital Sainte Anne
      • Paris, France, 75571
        • Hopital Saint Antione
      • Paris, France, 75651
        • Centre Hospitalier Pitie Salpetriere
      • Pierre Benite, France, 69495
        • Centre Hospitalier LYON SUD
      • Rouen, France, 76031
        • CHU Charles Nicolle
      • Saint-Etienne, France, 42055
        • Hôpital Bellevue
      • Strasbourg, France, 67091
        • Hôpital Civil
      • Toulouse, France, 31059
        • Hopital Purpan
      • Toulouse, France, 31059
        • Hopital Rangueil
  • Germany
      • Berlin, Germany, 10178
        • Praxis für Neurologie
      • Bonn, Germany, 53127
        • Rhein. F.-Wilhelms-Universität
      • Gießen, Germany, 35390
        • Praxis für Neurologie
      • Halle-Dölau, Germany, 6120
        • Städt. Krankenhaus Martha-Maria
      • Hamburg, Germany, 20249
        • Neurologische Praxis
      • Hannover, Germany, 30625
        • Med. Hochschule
      • Stuttgart, Germany, 70191
        • BurgerHospital
      • Tübingen, Germany, 72076
        • E.-Karls-Universität
      • Villingen-Schwenningen, Germany, 78054
        • Klinikum der Stadt Villingen-Schwenningen
  • Russian Federation
      • Moscow, Russian Federation, 115522
        • Centre of plastic surgery "Reconstruction and Recreation"
      • Moscow, Russian Federation, 117393
        • Institute of Medical Aestetic "Vallex-M"
      • Moscow, Russian Federation, 119021
        • Moscow Medical Academy
      • Moscow, Russian Federation, 123367
        • Scientific Research Institute of Neurology
      • Moscow, Russian Federation, 125367
        • Cosmetological Centre "Diamond"
      • Moscow, Russian Federation, 125367
        • National Medical Centre of Surgery
      • Moscow, Russian Federation, 142031
        • Federal Centre "Pediatric Rehabilitology"
      • Moscow, Russian Federation
        • Centre for Aesthetic Dermatology and Surgery of Russian Academy of Sciences
    • Kazakhstan
      • Alma-Ata, Kazakhstan, Russian Federation, 480070
        • Alma-Ata State Institute of Postgraduate Education
      • Alma-ata, Kazakhstan, Russian Federation
        • Rehabilitation Centre "Balbulak"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
- assessment of efficacy as assessed by treating physician at scheduled follow up visit
- data on adverse events since treatment with Dysport

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2005

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Y-47-52120-093

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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