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A Prospective, Non-interventional Survey to Evaluate Injection Intervals and Treatment Modalities of Botulinum Toxin A (BoNT-A) in Adult Patients Suffering From Upper Limb Spasticity After Stroke (DECIDE)

This study has been terminated.
(Participant enrolment was lower than expected)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01239628
First Posted: November 11, 2010
Last Update Posted: February 29, 2016
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.
Information provided by (Responsible Party):
Ipsen
November 10, 2010
November 11, 2010
February 29, 2016
December 2010
December 2015   (Final data collection date for primary outcome measure)
  • Documentation of the injection intervals [ Time Frame: 3 years ]
  • Documentation of treatment modalities [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT01239628 on ClinicalTrials.gov Archive Site
  • Documentation of the main reason(s) for change in injection intervals [ Time Frame: 3 years ]
  • Documentation of the main reason(s) for dose change(s) [ Time Frame: 3 years ]
  • Documentation of the patient satisfaction with the treatment [ Time Frame: 3 years ]
  • Documentation of the physician satisfaction with the treatment [ Time Frame: 3 years ]
Same as current
Not Provided
Not Provided
 
A Prospective, Non-interventional Survey to Evaluate Injection Intervals and Treatment Modalities of Botulinum Toxin A (BoNT-A) in Adult Patients Suffering From Upper Limb Spasticity After Stroke
A National, Prospective, Non-interventional Survey to Evaluate Injection Intervals and Treatment Modalities up to 3 Years Follow up of Botulinum Toxin A (BoNT-A) in Adult Patients Suffering From Upper Limb Spasticity Post-CVA (Cerebrovascular Accident)
The purpose of the protocol is to evaluate injection intervals and treatment modalities up to 3 years follow-up of botulinum toxin A (BoNT-A) in adult patients suffering from upper limb spasticity after stroke.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with a history of stroke, suffering from upper limb spasticity
Upper Limb Spasticity After Stroke
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
45
December 2015
December 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject able to comply with the protocol
  • Provision of written informed consent prior to collecting the data
  • Male or female patients of 18 years or older
  • Presenting with upper limb spasticity after stroke for which treatment with botulinum toxin A is indicated

Exclusion Criteria:

  • The subject has already been included in this survey
  • Patients who already received BoNT-A treatment for upper limb spasticity
  • Patients with known intolerance for BoNT-A
  • Subjects unable to comply with the protocol
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01239628
A-48-52120-152
No
Not Provided
Not Provided
Ipsen
Ipsen
Not Provided
Study Director: Medical Director, Neurology Ipsen
Ipsen
February 2016