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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
  Purpose

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.


Condition
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)
  Eligibility

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

Criteria

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
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: NCT01020500

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

No publications provided

Responsible Party: Ipsen Study Director, Ipsen
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on November 25, 2014