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Post Marketing Surveillance Study of Dysport

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00210431
First Posted: September 21, 2005
Last Update Posted: October 1, 2015
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.
Information provided by:
Ipsen
  Purpose
The purpose of this study is to provide further information regarding the risks and benefits of Dysport in marketed indications.

Condition Phase
Blepharospasm Hemifacial Spasm Cervical Dystonia Spasmodic Torticollis Cerebral Palsy Muscle Spasticity Cerebrovascular Accident Equinus Deformity Facial Hyperdynamic Lines Phase 4

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Ipsen:

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

Estimated Enrollment: 800
Study Start Date: October 2004
Study Completion Date: June 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00210431


Locations
France
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
Germany
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
Bürgerhospital
Stuttgart, Germany, 70191
E.-Karls-Universität
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, Russia, Russian Federation, 115522
Institute of Medical Aestetic "Vallex-M"
Moscow, Russia, Russian Federation, 117393
Moscow Medical Academy
Moscow, Russia, Russian Federation, 119021
Scientific Research Institute of Neurology
Moscow, Russia, Russian Federation, 123367
Cosmetological Centre "Diamond"
Moscow, Russia, Russian Federation, 125367
National Medical Centre of Surgery
Moscow, Russia, Russian Federation, 125367
Federal Centre "Pediatric Rehabilitology"
Moscow, Russia, Russian Federation, 142031
Centre for Aesthetic Dermatology and Surgery of Russian Academy of Sciences
Moscow, Russia, Russian Federation
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Jean-Loic Robin Ipsen
  More Information

ClinicalTrials.gov Identifier: NCT00210431     History of Changes
Other Study ID Numbers: Y-47-52120-093
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: October 1, 2015
Last Verified: September 2007

Additional relevant MeSH terms:
Blepharospasm
Cerebral Palsy
Dystonia
Stroke
Torticollis
Muscle Spasticity
Hemifacial Spasm
Equinus Deformity
Clubfoot
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dyskinesias
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
Spasm