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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 : March 31, 2020
Sponsor:
Information provided by:
Ipsen

Tracking Information
First Submitted Date September 13, 2005
First Posted Date September 21, 2005
Last Update Posted Date March 31, 2020
Study Start Date October 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: September 29, 2015)
  • - assessment of efficacy as assessed by treating physician at scheduled follow up visit
  • - data on adverse events since treatment with Dysport
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post Marketing Surveillance Study of Dysport
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 (CAMR)
Brief Summary The purpose of this study is to provide further information regarding the risks and benefits of Dysport in marketed indications.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Blepharospasm
  • Hemifacial Spasm
  • Cervical Dystonia
  • Spasmodic Torticollis
  • Cerebral Palsy
  • Muscle Spasticity
  • Cerebrovascular Accident
  • Equinus Deformity
  • Facial Hyperdynamic Lines
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 30, 2020)
783
Original Enrollment
 (submitted: September 13, 2005)
800
Actual Study Completion Date June 2006
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France,   Germany,   Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT00210431
Other Study ID Numbers Y-47-52120-093
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Ipsen
Collaborators Not Provided
Investigators
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date March 2020