Post Marketing Surveillance Study of Dysport

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00210431
First received: September 13, 2005
Last updated: September 12, 2007
Last verified: September 2007
  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: Observational Model: Defined Population
Time Perspective: Cross-Sectional
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:

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

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Centre Hospitalier Pitie Salpetriere
Paris, France, 75651
Hopital Sainte Anne
Paris, France, 75674
Hopital Saint Antione
Paris, France, 75571
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
Institute of Medical Aestetic "Vallex-M"
Moscow, Russia, Russian Federation, 117393
Scientific Research Institute of Neurology
Moscow, Russia, Russian Federation, 123367
Centre for Aesthetic Dermatology and Surgery of Russian Academy of Sciences
Moscow, Russia, Russian Federation
National Medical Centre of Surgery
Moscow, Russia, Russian Federation, 125367
Centre of plastic surgery "Reconstruction and Recreation"
Moscow, Russia, Russian Federation, 115522
Moscow Medical Academy
Moscow, Russia, Russian Federation, 119021
Federal Centre "Pediatric Rehabilitology"
Moscow, Russia, Russian Federation, 142031
Cosmetological Centre "Diamond"
Moscow, Russia, Russian Federation, 125367
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Jean-Loic Robin Ipsen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00210431     History of Changes
Other Study ID Numbers: Y-47-52120-093
Study First Received: September 13, 2005
Last Updated: September 12, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Ministry of Higher Education and Research

Additional relevant MeSH terms:
Equinus Deformity
Clubfoot
Congenital Abnormalities
Blepharospasm
Cerebral Palsy
Dystonia
Dystonic Disorders
Muscle Spasticity
Cerebral Infarction
Stroke
Torticollis
Hemifacial Spasm
Eyelid Diseases
Eye Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Movement Disorders
Muscular Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Brain Infarction

ClinicalTrials.gov processed this record on April 14, 2014