To Document the Effectiveness of BoNT-A Injection in Adult Subjects With Upper Limb Spasticity Following Stroke (ULIS2)

This study has been completed.
Information provided by:
Ipsen Identifier:
First received: November 24, 2009
Last updated: June 20, 2011
Last verified: June 2011
The purpose of the study is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one BoNT-A injection cycle in accordance with routine practices.

Muscle Spasticity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An International, Prospective Cohort to Document the Effectiveness of One BoNT-A Injection Cycle Based on Attainment of Individual Person-centred Goals in Adult Subjects Suffering From Upper Limb Spasticity Following Stroke

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS) following one BoNT-A injection cycle in accordance with routine practices [ Time Frame: Around 3 to 5 months post injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall attainment of the treatment goals using the GAS T score [ Time Frame: Around 3 to 5 months post injection ] [ Designated as safety issue: No ]
  • Result of standardized outcome measures (e.g., muscle tone reduction, pain scores, arm function test) [ Time Frame: Around 3 to 5 months post injection ] [ Designated as safety issue: No ]
  • Global assessment of benefits by both the investigator and the subject (or guardian) [ Time Frame: Around 3 to 5 months post injection ] [ Designated as safety issue: No ]

Enrollment: 469
Study Start Date: January 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital Clinics

Inclusion Criteria:

  • Upper limb spasticity following stroke
  • At least a 12-week interval between the last injection (BoNT-A or BoNT-B) and inclusion
  • Decision already been agreed to inject BoNT-A
  • Agreement with the subject on goal setting

Exclusion Criteria:

  • Contraindications to any BoNT-A preparations
  Contacts and Locations
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Please refer to this study by its identifier: NCT01020500

  Show 96 Study Locations
Sponsors and Collaborators
Study Director: Ipsen Study Director Ipsen
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ipsen Study Director, Ipsen Identifier: NCT01020500     History of Changes
Other Study ID Numbers: Y-79-52120-138 
Study First Received: November 24, 2009
Last Updated: June 20, 2011
Health Authority: China: Ministry of Health
Czech Republic: State Institute for Drug Control
France: French Data Protection Authority
Mexico: Federal Commission for Sanitary Risks Protection
Portugal: Data Protection Authority (CNPD)
Spain: Local Regulatory Authority ("Comunidad Autónoma")

Additional relevant MeSH terms:
Muscle Spasticity
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms processed this record on May 26, 2016