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

This study is currently recruiting participants.
Verified March 2014 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01840475
First received: April 23, 2013
Last updated: March 27, 2014
Last verified: March 2014

April 23, 2013
March 27, 2014
March 2013
October 2017   (final data collection date for primary outcome measure)
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). [ Time Frame: Final study visit: approximately 20 months after first visit ] [ Designated as safety issue: No ]

"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).

Same as current
Complete list of historical versions of study NCT01840475 on ClinicalTrials.gov Archive Site
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). [ Time Frame: Every 4 to 5 months starting from baseline up to 3 years ] [ Designated as safety issue: No ]

"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).

Same as current
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Not Provided
 
Arm Spasticity - Non-Interventional Study Early BIRD (BoNT Treatment: Initial and Repeated Documentation) [AS-NIS Early BIRD]
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.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Patients suffering from post-stroke arm spasticity registered with Neurological clinics, Rehab centers with BoNT out-patient clinics and neurological practices.

Post-stroke Arm Spasticity
Not Provided
  • Botulinum toxin type A (BoNT-A) injection (Dysport®) Naïve
    Subjects naïve to BoNT-A treatment.
  • Botulinum toxin type A (BoNT-A) Pre-treated

    Subjects pre-treated with BoNT-A.

    Investigators follow their individual injection protocol for the treatment with BoNT-A (modalities of administration in accordance with local Summary of Product Characteristics [SmPC]).

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
October 2017
October 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent prior to data collection
  • Hemiparesis and clinically relevant upper limb post-stroke spasticity (modified Ashworth scale 1+ or more for elbow flexors and wrist flexors)
  • With the intention to be treated with Dysport®
  • BoNT naïve or pre-treated with any BoNT product (If pre-treated, at least a 4 months interval between last injection and inclusion)

Exclusion Criteria:

  • Fixed contractures at the upper limb
  • Recurrent stroke
  • Previous surgery to treat spasticity of the affected upper limb
  • Sensitivity to Dysport® or to its excipients or any other contraindications as given in the local SmPC for Dysport®
Both
25 Years to 80 Years
No
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com
Austria,   Germany
 
NCT01840475
A-94-52120-174
No
Ipsen
Ipsen
Not Provided
Study Director: Andrea Reissig, PhD. Ipsen
Ipsen
March 2014

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