Clinical trial NCT00210431: Post Marketing Surveillance Study of Dysport
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 (CAMR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blepharospasm
Hemifacial Spasm
Cervical Dystonia
Spasmodic Torticollis
Cerebral Palsy
Muscle Spasticity
Cerebrovascular Accident
Equinus Deformity
Facial Hyperdynamic Lines
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 783
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE

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


Eligibility 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

Primary outcomes:
measure: - assessment of efficacy as assessed by treating physician at scheduled follow up visit
measure: - data on adverse events since treatment with Dysport
Secondary outcomes:
Other outcomes:
Locations:
city: Agen
country: France
facility: Centre Hospitalier Saint Esprit
city: Aix en Provence
country: France
facility: Center Hospitalier du Pays d'Aix
city: Chambery
country: France
facility: Centre Hospitalier
city: Marseille
country: France
facility: Hopital Timone Adultes
city: Nancy
country: France
facility: Hopital Central
city: Nantes
country: France
facility: Hopital Hotel Dieu
city: Nice
country: France
facility: Hopital Pasteur
city: Nimes
country: France
facility: Hopital Caremeau
city: Paris
country: France
facility: Hopital Saint Antione
city: Paris
country: France
facility: Centre Hospitalier Pitie Salpetriere
city: Paris
country: France
facility: Hopital Sainte Anne
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rouen
country: France
facility: CHU Charles Nicolle
city: Saint-Etienne
country: France
facility: Hopital Bellevue
city: Strasbourg
country: France
facility: Hopital Civil
city: Toulouse
country: France
facility: Hopital Purpan
city: Toulouse
country: France
facility: Hopital Rangueil
city: Berlin
country: Germany
facility: Praxis für Neurologie
city: Bonn
country: Germany
facility: Rhein. F.-Wilhelms-Universität
city: Gießen
country: Germany
facility: Praxis für Neurologie
city: Halle-Dölau
country: Germany
facility: Städt. Krankenhaus Martha-Maria
city: Hamburg
country: Germany
facility: Neurologische Praxis
city: Hannover
country: Germany
facility: Med. Hochschule
city: Stuttgart
country: Germany
facility: Bürgerhospital
city: Tübingen
country: Germany
facility: E.-Karls-Universität
city: Villingen-Schwenningen
country: Germany
facility: Klinikum der Stadt Villingen-Schwenningen
city: Alma-Ata
country: Russian Federation
facility: Alma-Ata State Institute of Postgraduate Education
state: Kazakhstan
city: Alma-ata
country: Russian Federation
facility: Rehabilitation Centre "Balbulak"
state: Kazakhstan
city: Moscow
country: Russian Federation
facility: Centre of plastic surgery "Reconstruction and Recreation"
city: Moscow
country: Russian Federation
facility: Institute of Medical Aestetic "Vallex-M"
city: Moscow
country: Russian Federation
facility: Moscow Medical Academy
city: Moscow
country: Russian Federation
facility: Scientific Research Institute of Neurology
city: Moscow
country: Russian Federation
facility: Cosmetological Centre "Diamond"
city: Moscow
country: Russian Federation
facility: National Medical Centre of Surgery
city: Moscow
country: Russian Federation
facility: Federal Centre "Pediatric Rehabilitology"
city: Moscow
country: Russian Federation
facility: Centre for Aesthetic Dermatology and Surgery of Russian Academy of Sciences
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: