Post Marketing Surveillance Study of Dysport

Completed

• Conditions: Cervical Dystonia; Cerebrovascular Accident; Blepharospasm; Spasmodic Torticollis; Cerebral Palsy; Hemifacial Spasm; Muscle Spasticity; Equinus Deformity; Facial Hyperdynamic Lines

• Registration Number: NCT00210431
• Lead Sponsor: Ipsen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Completion: 2006-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 783

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- assessment of efficacy as assessed by treating physician at scheduled follow up visit
- data on adverse events since treatment with Dysport

Trial Locations

Locations (35)

Hopital Purpan; 🇫🇷 Toulouse, France

Centre Hospitalier Saint Esprit; 🇫🇷 Agen, France

Hopital Timone Adultes; 🇫🇷 Marseille, France

Hopital Central; 🇫🇷 Nancy, France

Centre Hospitalier Pitie Salpetriere; 🇫🇷 Paris, France

Hopital Pasteur; 🇫🇷 Nice, France

Hopital Caremeau; 🇫🇷 Nimes, France

Hopital Saint Antione; 🇫🇷 Paris, France

Hopital Civil; 🇫🇷 Strasbourg, France

Hopital Rangueil; 🇫🇷 Toulouse, France

Praxis für Neurologie; 🇩🇪 Gießen, Germany

Bürgerhospital; 🇩🇪 Stuttgart, Germany

Rhein. F.-Wilhelms-Universität; 🇩🇪 Bonn, Germany

Med. Hochschule; 🇩🇪 Hannover, Germany

E.-Karls-Universität; 🇩🇪 Tübingen, Germany

Scientific Research Institute of Neurology; 🇷🇺 Moscow, Russian Federation

Moscow Medical Academy; 🇷🇺 Moscow, Russian Federation

Federal Centre "Pediatric Rehabilitology"; 🇷🇺 Moscow, Russian Federation

Centre for Aesthetic Dermatology and Surgery of Russian Academy of Sciences; 🇷🇺 Moscow, Russian Federation

Hopital Hotel Dieu; 🇫🇷 Nantes, France

Hopital Sainte Anne; 🇫🇷 Paris, France

Hopital Bellevue; 🇫🇷 Saint-Etienne, France

Klinikum der Stadt Villingen-Schwenningen; 🇩🇪 Villingen-Schwenningen, Germany

Center Hospitalier du Pays d'Aix; 🇫🇷 Aix en Provence, France

Centre Hospitalier; 🇫🇷 Chambery, France

CHU Charles Nicolle; 🇫🇷 Rouen, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Benite, France

Rehabilitation Centre "Balbulak"; 🇷🇺 Alma-ata, Kazakhstan, Russian Federation

Centre of plastic surgery "Reconstruction and Recreation"; 🇷🇺 Moscow, Russian Federation

Institute of Medical Aestetic "Vallex-M"; 🇷🇺 Moscow, Russian Federation

Städt. Krankenhaus Martha-Maria; 🇩🇪 Halle-Dölau, Germany

Neurologische Praxis; 🇩🇪 Hamburg, Germany

Alma-Ata State Institute of Postgraduate Education; 🇷🇺 Alma-Ata, Kazakhstan, Russian Federation

Cosmetological Centre "Diamond"; 🇷🇺 Moscow, Russian Federation

National Medical Centre of Surgery; 🇷🇺 Moscow, Russian Federation