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

March 30, 2020 updated by: Ipsen

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

302

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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®

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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]).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

"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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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: Approximately every 4 months starting from baseline up to 2 years

"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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

February 6, 2018

Study Completion (ACTUAL)

February 6, 2018

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

April 23, 2013

First Posted (ESTIMATE)

April 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-94-52120-174

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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