Post Marketing Surveillance Study of Dysport

NCT00210431 | Completed

• 1 other identifier: Y-47-52120-093
• Study Type: observational
• Target: 783
• Locations: 3 countries
• Sites: 36

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• - assessment of efficacy as assessed by treating physician at scheduled follow up visit

• - data on adverse events since treatment with Dysport

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (36)

Centre Hospitalier Saint Esprit

Agen, 47923, France

Location

Center Hospitalier du Pays d'Aix

Aix-en-Provence, 13616, France

Location

Centre Hospitalier

Chambéry, 73011, France

Location

Hopital Timone Adultes

Marseille, 13385, France

Location

Hopital Central

Nancy, 54035, France

Location

Hopital Hotel Dieu

Nantes, 44093, France

Location

Hopital Pasteur

Nice, 06002, France

Location

Hopital Caremeau

Nîmes, 30029, France

Location

Hopital Saint Antione

Paris, 75571, France

Location

Centre Hospitalier Pitie Salpetriere

Paris, 75651, France

Location

Hopital Sainte Anne

Paris, 75674, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU Charles Nicolle

Rouen, 76031, France

Location

Hopital Bellevue

Saint-Etienne, 42055, France

Location

Hopital Civil

Strasbourg, 67091, France

Location

Hopital Purpan

Toulouse, 31059, France

Location

Hopital Rangueil

Toulouse, 31059, France

Location

Praxis für Neurologie

Berlin, 10178, Germany

Location

Rhein. F.-Wilhelms-Universität

Bonn, 53127, Germany

Location

Praxis für Neurologie

Giessen, 35390, Germany

Location

Städt. Krankenhaus Martha-Maria

Halle-Dölau, 6120, Germany

Location

Neurologische Praxis

Hamburg, 20249, Germany

Location

Med. Hochschule

Hanover, 30625, Germany

Location

Bürgerhospital

Stuttgart, 70191, Germany

Location

E.-Karls-Universität

Tübingen, 72076, Germany

Location

Klinikum der Stadt Villingen-Schwenningen

Villingen-Schwenningen, 78054, Germany

Location

Alma-Ata State Institute of Postgraduate Education

Alma-Ata, Kazakhstan, 480070, Russia

Location

Rehabilitation Centre "Balbulak"

Alma-Ata, Kazakhstan, Russia

Location

Centre of plastic surgery "Reconstruction and Recreation"

Moscow, 115522, Russia

Location

Institute of Medical Aestetic "Vallex-M"

Moscow, 117393, Russia

Location

Moscow Medical Academy

Moscow, 119021, Russia

Location

Scientific Research Institute of Neurology

Moscow, 123367, Russia

Location

Cosmetological Centre "Diamond"

Moscow, 125367, Russia

Location

National Medical Centre of Surgery

Moscow, 125367, Russia

Location

Federal Centre "Pediatric Rehabilitology"

Moscow, 142031, Russia

Location

Centre for Aesthetic Dermatology and Surgery of Russian Academy of Sciences

Moscow, Russia

Location

MeSH Terms

Conditions

Blepharospasm; Hemifacial Spasm; Torticollis; Cerebral Palsy; Muscle Spasticity; Stroke; Equinus Deformity

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Mouth Diseases; Stomatognathic Diseases; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dystonia; Dyskinesias; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Talipes; Foot Deformities, Acquired; Foot Deformities; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: October 1, 2004
• Study Completion: June 1, 2006
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

RU (10); DE (9); FR (17)