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Clinical Trials/NCT01239628
NCT01239628
Terminated
Not Applicable

A National, Prospective, Non-interventional Survey to Evaluate Injection Intervals and Treatment Modalities up to 3 Years Follow up of Botulinum Toxin A in Adult Subjects Suffering From Upper Limb Spasticity Post-CVA (Cerebrovascular Accident)

Ipsen11 sites in 1 country45 target enrollmentDecember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Upper Limb Spasticity After Stroke
Sponsor
Ipsen
Enrollment
45
Locations
11
Primary Endpoint
Documentation of the injection intervals
Status
Terminated
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2010
End Date
December 2015
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Ipsen
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Documentation of the injection intervals

Time Frame: 3 years

Documentation of treatment modalities

Time Frame: 3 years

Secondary Outcomes

  • Documentation of the main reason(s) for dose change(s)(3 years)
  • Documentation of the main reason(s) for change in injection intervals(3 years)
  • Documentation of the physician satisfaction with the treatment(3 years)
  • Documentation of the patient satisfaction with the treatment(3 years)

Study Sites (11)

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