Post Marketing Surveillance Study of Dysport - Full Text View

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 IV

Genetics Home Reference related topics:

early-onset primary dystonia familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics:

Botox Cerebral Palsy Dystonia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Cross-Sectional, Defined Population, Prospective Study

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.

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
	Hopital Timone Adultes
	Marseille, France, 13385
	Centre Hospitalier
	Chambery, France, 73011
	Centre Hospitalier Lyon Sud
	Pierre Benite, France, 69495
	Hopital Caremeau
	Nimes, France, 30029
	Hopital Sainte Anne
	Paris, France, 75674
	CHU Charles Nicolle
	Rouen, France, 76031
	Hopital Purpan
	Toulouse, France, 31059
	Hopital Civil
	Strasbourg, France, 67091
	Hopital Bellevue
	Saint-Etienne, France, 42055
	Centre Hospitalier Saint Esprit
	Agen, France, 47923
	Hopital Hotel Dieu
	Nantes, France, 44093
	Hopital Pasteur
	Nice, France, 06002
	Center Hospitalier du Pays d'Aix
	Aix en Provence, France, 13616
	Hopital Rangueil
	Toulouse, France, 31059
	Centre Hospitalier Pitie Salpetriere
	Paris, France, 75651
	Hopital Central
	Nancy, France, 54035
	Hopital Saint Antione
	Paris, France, 75571

Germany
	Med. Hochschule
	Hannover, Germany, 30625
	Neurologische Praxis
	Hamburg, Germany, 20249
	Klinikum der Stadt Villingen-Schwenningen
	Villingen-Schwenningen, Germany, 78054
	Praxis für Neurologie
	Berlin, Germany, 10178
	Bürgerhospital
	Stuttgart, Germany, 70191
	E.-Karls-Universität
	Tübingen, Germany, 72076
	Städt. Krankenhaus Martha-Maria
	Halle-Dölau, Germany, 6120
	Rhein. F.-Wilhelms-Universität
	Bonn, Germany, 53127
	Praxis für Neurologie
	Gießen, Germany, 35390

Russian Federation, Kazakhstan
	Rehabilitation Centre "Balbulak"
	Alma-ata, Kazakhstan, Russian Federation
	Alma-Ata State Institute of Postgraduate Education
	Alma-Ata, Kazakhstan, Russian Federation, 480070

Russian Federation, Russia
	Institute of Medical Aestetic "Vallex-M"
	Moscow, Russia, Russian Federation, 117393
	Centre of plastic surgery "Reconstruction and Recreation"
	Moscow, Russia, Russian Federation, 115522
	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
	Scientific Research Institute of Neurology
	Moscow, Russia, Russian Federation, 123367
	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

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

Study placed in the following topic categories:

Benign essential blepharospasm

Mouth Diseases

Spasm

Dystonic Disorders

Cerebral Infarction

Brain Damage, Chronic

Talipes equinovarus

Dystonia

Brain Diseases

Cerebrovascular Disorders

Hemifacial Spasm

Signs and Symptoms

Cerebral Palsy

Musculoskeletal Diseases

Movement Disorders

Muscle Hypertonia

Brain Ischemia

Botulinum Toxin Type A

Congenital Abnormalities

Brain Injuries

Facies

Eye Diseases

Stroke

Vascular Diseases

Clubfoot

Central Nervous System Diseases

Ischemia

Blepharospasm

Dyskinesias

Paralysis

Additional relevant MeSH terms:

Foot Deformities, Acquired

Neuromuscular Manifestations

Nervous System Diseases

Eyelid Diseases

Cardiovascular Diseases

Foot Deformities, Congenital

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00210431