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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01840475
First received: April 23, 2013
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

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.


Condition
Post-stroke Arm Spasticity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • 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).



Secondary Outcome Measures:
  • 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: Approximateky every 4 months starting from baseline up to 2 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).



Estimated Enrollment: 300
Study Start Date: March 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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]).


  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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®
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01840475

Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
Austria
Recruiting
Hermagor, Austria
Germany
Recruiting
Berlin, Germany
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Martin Gerwe, MD Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01840475     History of Changes
Other Study ID Numbers: A-94-52120-174
Study First Received: April 23, 2013
Last Updated: September 30, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety
Switzerland: Swissmedic

Additional relevant MeSH terms:
Stroke
Muscle Spasticity
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014