OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity

March 14, 2017 updated by: Allergan
This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
  • United States
    • Kansas
      • Overland Park, Kansas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Upper limb spasticity in the elbow and shoulder due to stroke, with the most recent stroke at least 3 months ago

Exclusion Criteria:

  • Spasticity in the non-study upper limb that requires treatment
  • Presence of fixed contractures in of the study muscles in elbow or shoulder
  • Profound atrophy of muscles to be injected
  • Previous surgical intervention, nerve block, or muscle block for the treatment of spasticity in the study limb in the last 12 months
  • Injection of corticosteroids or anesthetics, use of casting or dynamic splinting or constraint-induced movement therapy (CIMT) for the study limb within 3 months
  • Ultrasound therapy, electrical stimulation, or acupuncture in the study limb within 1 month
  • Condition other than stroke contributing to upper limb spasticity
  • Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, and/or amyotrophic lateral sclerosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: onabotulinumtoxinA 500U
OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
Biological: onabotulinumtoxinA
OnabotulinumtoxinA injected into predefined muscles of the study limb on Day 1.
Other Names:
  • BOTOX®
  • botulinum toxin type A
Experimental: onabotulinumtoxinA 300U
OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
Biological: onabotulinumtoxinA
OnabotulinumtoxinA injected into predefined muscles of the study limb on Day 1.
Other Names:
  • BOTOX®
  • botulinum toxin type A
Placebo Comparator: placebo (normal saline)
Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
Drug: placebo (normal saline)
Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale
Time Frame: Baseline, Week 6
The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the elbow flexors by passively moving the elbow flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Baseline, Week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale
Time Frame: Baseline, Week 6
The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the shoulder adductors by passively moving the shoulder adductor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Baseline, Week 6
Change From Baseline in Pain on an 11-Point Scale
Time Frame: Baseline, Week 6
The patient is asked to select a number that best describes his/her pain in the treated areas of the study limb on an 11-point scale from 0 = "no pain" to 10 = "pain as bad as can be imagined". Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score >0 are included in the analyses. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Baseline, Week 6
Change From Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
Time Frame: Baseline, Week 6
The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The dressing domain was calculated based on the average of 2 questions.
Baseline, Week 6
Change From Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
Time Frame: Baseline, Week 6
The SIA-UL asks the patient to assess the impact of upper limb spasticity his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The showering/bathing domain was based on a single question.
Baseline, Week 6
Change From Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
Time Frame: Baseline, Week 6
The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The self-care domain was calculated based on the average of 4 questions.
Baseline, Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 191622-127
  • 2013-002346-37 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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