Muscle SpasticityPhase 3NCT02145676
OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity
A Phase 3 study testing onabotulinumtoxinA in people with Muscle Spasticity and Stroke, run by Allergan at 2 sites in 2 countries.
Trial summary
This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Muscle Spasticity, Stroke
- What is being tested?
- onabotulinumtoxinA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2014to Dec 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Upper limb spasticity in the elbow and shoulder due to stroke, with the most recent stroke at least 3 months ago
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.
- Conditions
- Muscle Spasticity, Stroke
- Being tested
- onabotulinumtoxinA, placebo (normal saline)
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onabotulinumtoxinABiological
Also called BOTOX®, botulinum toxin type A
OnabotulinumtoxinA injected into predefined muscles of the study limb on Day 1.
placebo (normal saline)Drug
Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| onabotulinumtoxinA 500U | Experimental | OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1. Receives: Biological: onabotulinumtoxinA |
| onabotulinumtoxinA 300U | Experimental | OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1. Receives: Biological: onabotulinumtoxinA |
| placebo (normal saline) | Placebo comparator | Placebo (normal saline) injected into predefined muscles of the study limb on Day 1. Receives: Drug: placebo (normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale
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.
Measured: Baseline, Week 6
Secondary outcomes (5)
Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale
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.
Measured: Baseline, Week 6
Change From Baseline in Pain on an 11-Point Scale
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.
Measured: Baseline, Week 6
Change From Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
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.
Measured: Baseline, Week 6
Change From Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
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.
Measured: Baseline, Week 6
Change From Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
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.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Muscle SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145676
- Sponsor's protocol ID
- 191622-127
- Other IDs
- 2013-002346-37
- Status last verified
- Mar 2017
- First submitted
- 21 May 2014
- Last updated
- 12 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity
- ClinicalTrials.gov ID
- NCT02145676
- Acronym / sponsor ID
- 191622-127
- Conditions
- Muscle Spasticity, Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 53 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 May 2014 (estimated)
- Results
- Posted 14 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| onabotulinumtoxinA 500U | Experimental | Biological: onabotulinumtoxinAOnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1. |
| onabotulinumtoxinA 300U | Experimental | Biological: onabotulinumtoxinAOnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1. |
| placebo (normal saline) | Placebo comparator | Drug: placebo (normal saline)Placebo (normal saline) injected into predefined muscles of the study limb on Day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Upper limb spasticity in the elbow and shoulder due to stroke, with the most recent stroke at least 3 months ago
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| onabotulinumtoxinAAlso: BOTOX®, botulinum toxin type AOnabotulinumtoxinA injected into predefined muscles of the study limb on Day 1. | Biological | onabotulinumtoxinA 300U, onabotulinumtoxinA 500U |
| placebo (normal saline)Placebo (normal saline) injected into predefined muscles of the study limb on Day 1. | Drug | placebo (normal saline) |
Primary outcome
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.
5 secondary outcomes
Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale
Time frame: Baseline, Week 6
Change From Baseline in Pain on an 11-Point Scale
Time frame: 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
Change From Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing onabotulinumtoxinA in people with Muscle Spasticity and Stroke, run by Allergan at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.