A Prospective, Non-interventional Survey to Evaluate Injection Intervals and Treatment Modalities of Botulinum Toxin A (BoNT-A) in Adult Patients Suffering From Upper Limb Spasticity After Stroke (DECIDE)

March 30, 2020 updated by: Ipsen

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)

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

45

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

  • Belgium
      • Antwerpen, Belgium
        • ZNA Middelheim
      • Antwerpen, Belgium
        • St- Augustinus
      • Brugge, Belgium, 8000
        • AZ St-Jan
      • Edegem, Belgium
        • RevalidatieZiekenhuis RevArte
      • Gent, Belgium, 9000
        • AZ Sint Lucas
      • Herk-de-Stad, Belgium
        • Revalidatiecentrum St Ursula
      • Lanaken, Belgium
        • ZOL, Campus Sint Barbara
      • Lier, Belgium
        • Heilig Hart Ziekenhuis
      • Lodelinsart, Belgium
        • Hôpital Marie Curie
      • Montigny-le-Tilleul, Belgium
        • CHU Leonardo da Vinci
      • Verviers, Belgium
        • CHPLT Peltzer

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a history of stroke, suffering from upper limb spasticity

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Documentation of the injection intervals
Time Frame: 3 years
3 years
Documentation of treatment modalities
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Documentation of the main reason(s) for change in injection intervals
Time Frame: 3 years
3 years
Documentation of the main reason(s) for dose change(s)
Time Frame: 3 years
3 years
Documentation of the patient satisfaction with the treatment
Time Frame: 3 years
3 years
Documentation of the physician satisfaction with the treatment
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Ipsen

Investigators

  • Study Director: Medical Director, Neurology, 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

December 1, 2010

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

November 10, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (Estimate)

November 11, 2010

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-48-52120-152

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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