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

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ClinicalTrials.gov Identifier: NCT01020500
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : June 21, 2011
Sponsor:
Information provided by:
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.

Condition or disease
Muscle Spasticity

Study Type : Observational
Actual Enrollment : 469 participants
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
Study Start Date : January 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011



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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020500


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ipsen Study Director, Ipsen
ClinicalTrials.gov Identifier: NCT01020500     History of Changes
Other Study ID Numbers: Y-79-52120-138
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: June 21, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms