To Document the Effectiveness of BoNT-A Injection in Adult Subjects With 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.

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Key information

Conditions

Muscle Spasticity Muscle Hypertonia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rankin Park (site 036006), Newcastle, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Secondary outcomes

Overall attainment of the treatment goals using the GAS T score

Time frame: Around 3 to 5 months post injection
Result of standardized outcome measures (e.g., muscle tone reduction, pain scores, arm function test)

Time frame: Around 3 to 5 months post injection
Global assessment of benefits by both the investigator and the subject (or guardian)

Time frame: Around 3 to 5 months post injection

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Acronym: ULIS2

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Nov 25, 2009
Registry last updated: Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed