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Post Marketing Surveillance Study of Dysport

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00210431
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : January 25, 2019
Information provided by:

Brief Summary:
The purpose of this study is to provide further information regarding the risks and benefits of Dysport in marketed indications.

Condition or disease
Blepharospasm Hemifacial Spasm Cervical Dystonia Spasmodic Torticollis Cerebral Palsy Muscle Spasticity Cerebrovascular Accident Equinus Deformity Facial Hyperdynamic Lines

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Study Type : Observational
Enrollment : 800 participants
Observational Model: Other
Time Perspective: Prospective
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.
Study Start Date : October 2004
Actual Study Completion Date : June 2006

Primary Outcome Measures :
  1. - assessment of efficacy as assessed by treating physician at scheduled follow up visit
  2. - data on adverse events since treatment with Dysport

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00210431

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

Layout table for additonal information Identifier: NCT00210431     History of Changes
Other Study ID Numbers: Y-47-52120-093
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Cerebral Palsy
Muscle Spasticity
Hemifacial Spasm
Equinus Deformity
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Dystonic Disorders
Movement Disorders
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Eyelid Diseases
Eye Diseases
Mouth Diseases
Stomatognathic Diseases