Post Marketing Surveillance Study of Dysport

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

Completed

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Key information

Conditions

Blepharospasm Brain Damage, Chronic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Palsy Cerebrovascular Accident Cerebrovascular Disorders Cervical Dystonia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyskinesias Dystonia EQUINUS DEFORMITY Eye Diseases Eyelid Diseases Facial Hyperdynamic Lines Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Hemifacial Spasm Limb Deformities, Congenital Lower Extremity Deformities, Congenital Mouth Diseases Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm Spasmodic Torticollis Stomatognathic Diseases Stroke Talipes Torticollis Vascular Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Saint Esprit, Agen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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)

Important dates

Study start: 2004
Study completion: 2006
First posted: Sep 21, 2005
Registry last updated: Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed