Post Marketing Surveillance Study of Dysport

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00210431

Enrollment

783

Registered

2005-09-21

Start date

2004-10-31

Completion date

2006-06-30

Last updated

2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France, Germany, Russia

Outcome results