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

Completed

• Conditions: Muscle Spasticity

• Registration Number: NCT01020500
• Lead Sponsor: Ipsen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Study Start: 2010-01
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 469

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Around 3 to 5 months post injection

Secondary Outcome Measures

Name	Time	Method
Global assessment of benefits by both the investigator and the subject (or guardian)	Around 3 to 5 months post injection
Overall attainment of the treatment goals using the GAS T score	Around 3 to 5 months post injection
Result of standardized outcome measures (e.g., muscle tone reduction, pain scores, arm function test)	Around 3 to 5 months post injection

Trial Locations

Locations (96)

Rankin Park (site 036006); 🇦🇺 Newcastle, Australia

Northshore Private Hospital (site 036003); 🇦🇺 Sydney, Australia

Royal Prince Alfred Hospital (site 036005); 🇦🇺 Sydney, Australia

Ryde Rehabilitation Center (site 036002); 🇦🇺 Sydney, Australia

St Joseph's Hospital (site 036004); 🇦🇺 Sydney, Australia

St Vincent's Hospital (site 036001); 🇦🇺 Sydney, Australia

NÖ LKH Grimmenstein-Hochegg (site 040002); 🇦🇹 Grimmenstein, Austria

Gaital-Kliniken Hermagor (site 040001); 🇦🇹 Hermagor, Austria

Revalidatieziekenhuis Hof ter Schelde, August Vermeylenlaan 6 (site 056001); 🇧🇪 Antwerpen, Belgium

AZ St. Jan, Ruddershove 10, (site 056002); 🇧🇪 Brugge, Belgium

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