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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

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
        • Hôpital Hotel Dieu
      • Nice, France, 06002
        • Hôpital Pasteur
      • Nimes, France, 30029
        • Hopital Caremeau
      • Paris, France, 75674
        • Hopital 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
        • Hopital Bellevue
      • Strasbourg, France, 67091
        • Hôpital CIVIL
      • Toulouse, France, 31059
        • Hôpital 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
        • Bürgerhospital
      • 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

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

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

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

October 1, 2004

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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