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

Post-stroke Arm Spasticity Clinical Trial

— EARLYBIRD  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840475
• Other study ID #: A-94-52120-174
• Status: Completed
• Start date: March 2013
• Est. completion date: February 6, 2018

Study information

• Verified date: March 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: February 6, 2018
• Est. primary completion date: February 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent prior to data collection

• Hemiparesis and clinically relevant upper limb post-stroke spasticity

• Treated with Dysport® or with the intention to be treated with Dysport® according to local SmPC

• BoNT naïve or pre-treated with any BoNT product

Exclusion Criteria:

• Recurrent stroke

• Sensitivity to Dysport® or to its excipients or any other contraindications as given in the local SmPC for Dysport®

Related Conditions & MeSH terms

• Muscle Spasticity
• Post-stroke Arm Spasticity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Austria,  France,  Germany,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of modified Ashworth scale (MAS) between patients with early start of treatment and patients with late start of treatment in the overall population (naive and pre-treated).	"Early" and "late" start of treatment according to the first and third quartiles time distribution between stroke and start of treatment with BoNT-A.; Investigation of effectiveness of BoNT-A treatment on the evolution of spasticity using MAS (sum of elbow and wrist flexors, EWF).	Final study visit: approximately 20 months after first visit
Secondary	Comparison of modified Ashworth scale (MAS) between patients with early start of treatment and patients with late start of treatment in the overall population (naive and pre-treated).	"Early" and "late" start of treatment according to the first and third quartiles time distribution between stroke and start of treatment with BoNT-A.; Investigation of effectiveness of BoNT-A treatment on the evolution of spasticity using MAS (sum of elbow and wrist flexors, EWF).	Approximately every 4 months starting from baseline up to 2 years