NCT01840475

Arm Spasticity - Non-Interventional Study Early BIRD (BoNT Treatment: Initial and Repeated Documentation)

International, Multicenter, Non-interventional, Prospective, Longitudinal Study to Investigate the Effectiveness of Botulinum Toxin A (Dysport®) Injections in Patients Suffering From Post-stroke Arm Spasticity With Respect to Early, Medium or Late Start of Treatment.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 302 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

Botulinum toxin A (BoNT-A) is effective and safe in alleviating post-stroke spasticity and reducing the burden of associated symptoms. The hypothesis for this non-interventional study in arm spasticity (AS-NIS early BIRD) is no significant difference between naïve and pre-treated patients. The patients will be divided in sub-groups according to the time interval between occurrence of stroke and start of treatment (early, medium and late start of treatment according to the first and third quartiles time distribution). It is hypothesized that the "early" start of treatment group will have a reduced modified Ashworth scale (MAS) on the elbow and wrist flexors when compared to the "late" start of treatment group.

Conditions

• Post-stroke Arm Spasticity

Timeline

• Start date: 2013-03-01
• Primary completion: 2018-02-06
• Completion: 2018-02-06
• First posted: 2013-04-25
• Last updated: 2020-03-31

Locations

5 sites across 5 countries: Austria, France, Germany, Netherlands, Switzerland