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Post Marketing Surveillance Study of Dysport

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00210431
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : January 25, 2019
Sponsor:
Information provided by:
Ipsen

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

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

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Study Type : Observational
Enrollment : 800 participants
Observational Model: Other
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.
Study Start Date : October 2004
Actual Study Completion Date : June 2006





Primary Outcome Measures :
  1. - assessment of efficacy as assessed by treating physician at scheduled follow up visit
  2. - data on adverse events since treatment with Dysport


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210431


Locations
Show Show 36 study locations
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen

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ClinicalTrials.gov Identifier: NCT00210431    
Other Study ID Numbers: Y-47-52120-093
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Muscle Spasticity
Equinus Deformity
Talipes
Clubfoot
Hemifacial Spasm
Cerebral Palsy
Dystonia
Stroke
Torticollis
Blepharospasm
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Dyskinesias
Dystonic Disorders
Movement Disorders
Congenital Abnormalities
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Eyelid Diseases
Eye Diseases
Mouth Diseases