Post Marketing Surveillance Study of Dysport

Cerebral Palsy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210431
• Other study ID #: Y-47-52120-093
• Status: Completed
• Start date: October 2004
• Est. completion date: June 2006

Study information

• Verified date: March 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 783
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharospasm
• Cerebral Palsy
• Cerebrovascular Accident
• Cervical Dystonia
• Clubfoot
• Dystonia
• Equinus Deformity
• Facial Hyperdynamic Lines
• Hemifacial Spasm
• Muscle Spasticity
• Spasmodic Torticollis
• Stroke
• Torticollis

Locations

Country	Name	City	State
France	Centre Hospitalier Saint Esprit	Agen
France	Center Hospitalier du Pays d'Aix	Aix en Provence
France	Centre Hospitalier	Chambery
France	Hopital Timone Adultes	Marseille
France	Hopital Central	Nancy
France	Hopital Hotel Dieu	Nantes
France	Hopital Pasteur	Nice
France	Hopital Caremeau	Nimes
France	Centre Hospitalier Pitie Salpetriere	Paris
France	Hopital Saint Antione	Paris
France	Hopital Sainte Anne	Paris
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	CHU Charles Nicolle	Rouen
France	Hopital Bellevue	Saint-Etienne
France	Hopital Civil	Strasbourg
France	Hopital Purpan	Toulouse
France	Hopital Rangueil	Toulouse
Germany	Praxis für Neurologie	Berlin
Germany	Rhein. F.-Wilhelms-Universität	Bonn
Germany	Praxis für Neurologie	Gießen
Germany	Städt. Krankenhaus Martha-Maria	Halle-Dölau
Germany	Neurologische Praxis	Hamburg
Germany	Med. Hochschule	Hannover
Germany	Bürgerhospital	Stuttgart
Germany	E.-Karls-Universität	Tübingen
Germany	Klinikum der Stadt Villingen-Schwenningen	Villingen-Schwenningen
Russian Federation	Alma-Ata State Institute of Postgraduate Education	Alma-Ata	Kazakhstan
Russian Federation	Rehabilitation Centre "Balbulak"	Alma-ata	Kazakhstan
Russian Federation	Centre for Aesthetic Dermatology and Surgery of Russian Academy of Sciences	Moscow
Russian Federation	Centre of plastic surgery "Reconstruction and Recreation"	Moscow
Russian Federation	Cosmetological Centre "Diamond"	Moscow
Russian Federation	Federal Centre "Pediatric Rehabilitology"	Moscow
Russian Federation	Institute of Medical Aestetic "Vallex-M"	Moscow
Russian Federation	Moscow Medical Academy	Moscow
Russian Federation	National Medical Centre of Surgery	Moscow
Russian Federation	Scientific Research Institute of Neurology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

France,  Germany,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- assessment of efficacy as assessed by treating physician at scheduled follow up visit
Primary	- data on adverse events since treatment with Dysport