Post Marketing Surveillance Study of Dysport
This study has been completed.
Sponsor:
Ipsen
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00210431
First received: September 13, 2005
Last updated: September 12, 2007
Last verified: September 2007
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Purpose
The purpose of this study is to provide further information regarding the risks and benefits of Dysport in marketed indications.
| Condition | Phase |
|---|---|
|
Blepharospasm Hemifacial Spasm Cervical Dystonia Spasmodic Torticollis Cerebral Palsy Muscle Spasticity Cerebrovascular Accident Equinus Deformity Facial Hyperdynamic Lines |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Cross-Sectional Time Perspective: Prospective |
| Official 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
benign essential blepharospasm
dopa-responsive dystonia
early-onset primary dystonia
U.S. FDA Resources
Further study details as provided by Ipsen:
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210431
Locations
| France | |
| Centre Hospitalier Saint Esprit | |
| Agen, France, 47923 | |
| Center Hospitalier du Pays d'Aix | |
| Aix en Provence, France, 13616 | |
| Centre Hospitalier | |
| Chambery, France, 73011 | |
| Hopital Timone Adultes | |
| Marseille, France, 13385 | |
| Hopital Central | |
| Nancy, France, 54035 | |
| Hopital Hotel Dieu | |
| Nantes, France, 44093 | |
| Hopital Pasteur | |
| Nice, France, 06002 | |
| Hopital Caremeau | |
| Nimes, France, 30029 | |
| Centre Hospitalier Pitie Salpetriere | |
| Paris, France, 75651 | |
| Hopital Sainte Anne | |
| Paris, France, 75674 | |
| Hopital Saint Antione | |
| Paris, France, 75571 | |
| Centre Hospitalier Lyon Sud | |
| Pierre Benite, France, 69495 | |
| CHU Charles Nicolle | |
| Rouen, France, 76031 | |
| Hopital Bellevue | |
| Saint-Etienne, France, 42055 | |
| Hopital Civil | |
| Strasbourg, France, 67091 | |
| Hopital Purpan | |
| Toulouse, France, 31059 | |
| Hopital Rangueil | |
| Toulouse, France, 31059 | |
| Germany | |
| Praxis für Neurologie | |
| Berlin, Germany, 10178 | |
| Rhein. F.-Wilhelms-Universität | |
| Bonn, Germany, 53127 | |
| Praxis für Neurologie | |
| Gießen, Germany, 35390 | |
| Städt. Krankenhaus Martha-Maria | |
| Halle-Dölau, Germany, 6120 | |
| Neurologische Praxis | |
| Hamburg, Germany, 20249 | |
| Med. Hochschule | |
| Hannover, Germany, 30625 | |
| Bürgerhospital | |
| Stuttgart, Germany, 70191 | |
| E.-Karls-Universität | |
| Tübingen, Germany, 72076 | |
| Klinikum der Stadt Villingen-Schwenningen | |
| Villingen-Schwenningen, Germany, 78054 | |
| Russian Federation | |
| Alma-Ata State Institute of Postgraduate Education | |
| Alma-Ata, Kazakhstan, Russian Federation, 480070 | |
| Rehabilitation Centre "Balbulak" | |
| Alma-ata, Kazakhstan, Russian Federation | |
| Institute of Medical Aestetic "Vallex-M" | |
| Moscow, Russia, Russian Federation, 117393 | |
| Scientific Research Institute of Neurology | |
| Moscow, Russia, Russian Federation, 123367 | |
| Centre for Aesthetic Dermatology and Surgery of Russian Academy of Sciences | |
| Moscow, Russia, Russian Federation | |
| National Medical Centre of Surgery | |
| Moscow, Russia, Russian Federation, 125367 | |
| Centre of plastic surgery "Reconstruction and Recreation" | |
| Moscow, Russia, Russian Federation, 115522 | |
| Moscow Medical Academy | |
| Moscow, Russia, Russian Federation, 119021 | |
| Federal Centre "Pediatric Rehabilitology" | |
| Moscow, Russia, Russian Federation, 142031 | |
| Cosmetological Centre "Diamond" | |
| Moscow, Russia, Russian Federation, 125367 | |
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Jean-Loic Robin | Ipsen |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00210431 History of Changes |
| Other Study ID Numbers: | Y-47-52120-093 |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 12, 2007 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices France: Ministry of Higher Education and Research |
Additional relevant MeSH terms:
|
Congenital Abnormalities Blepharospasm Cerebral Palsy Equinus Deformity Clubfoot Dystonia Dystonic Disorders Muscle Spasticity Cerebral Infarction Stroke Torticollis Hemifacial Spasm Eyelid Diseases Eye Diseases Brain Damage, Chronic |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Foot Deformities, Acquired Foot Deformities Musculoskeletal Diseases Foot Deformities, Congenital Dyskinesias Neurologic Manifestations Signs and Symptoms Movement Disorders Muscular Diseases Muscle Hypertonia Neuromuscular Manifestations Brain Infarction |
ClinicalTrials.gov processed this record on May 16, 2013