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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01239628
First received: November 10, 2010
Last updated: March 27, 2014
Last verified: March 2014

November 10, 2010
March 27, 2014
December 2010
December 2015   (final data collection date for primary outcome measure)
  • Documentation of the injection intervals [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Documentation of treatment modalities [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Documentation of the main reason(s) for dose change(s) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Documentation of the patient satisfaction with the treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Documentation of the physician satisfaction with the treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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.
 
Active, not recruiting
34
January 2016
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01239628
A-48-52120-152
No
Ipsen
Ipsen
Not Provided
Study Director: Medical Director, Neurology Ipsen
Ipsen
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP