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)

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

Hopital Saint Antione; 🇫🇷 Paris, France

Centre Hospitalier Pitie Salpetriere; 🇫🇷 Paris, France

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