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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT01020500
First received: November 24, 2009
Last updated: June 20, 2011
Last verified: June 2011

November 24, 2009
June 20, 2011
January 2010
May 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01020500 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
To Document the Effectiveness of BoNT-A Injection in Adult Subjects With Upper Limb Spasticity Following Stroke
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

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.

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

Hospital Clinics

Muscle Spasticity
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
469
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Mexico,   Belgium,   Italy,   Korea, Republic of,   France,   Portugal,   Taiwan,   Finland,   Sweden,   United Kingdom,   Czech Republic,   Russian Federation,   Austria,   Malaysia,   Spain,   Thailand,   Germany,   Philippines,   Australia,   China,   Singapore
 
NCT01020500
Y-79-52120-138
No
Ipsen Study Director, Ipsen
Ipsen
Not Provided
Study Director: Ipsen Study Director Ipsen
Ipsen
June 2011

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