Muscle SpasticityPhase 3NCT02145689
Long-Term Study of 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.
Trial summary
This is a long-term 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?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to May 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- For patients entering from the 191622-127 study, successful completion of study 191622-127
- For patients entering directly into study 191622-129, 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
About this study
This is a long-term safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.
- Conditions
- Muscle Spasticity, Stroke
- Being tested
- onabotulinumtoxinA
- 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
Up to 4 treatments of onabotulinumtoxinA injected into muscles of the study limb on fulfillment of the retreatment criteria.
| Study group | Role | What they receive |
|---|---|---|
| onabotulinumtoxinA Dose 1 | Experimental | Up to 4 treatments of onabotulinumtoxinA Dose 1 injected into muscles of the study limb on fulfillment of the retreatment criteria. Receives: Biological: onabotulinumtoxinA |
| onabotulinumtoxinA Dose 2 | Experimental | Up to 4 treatments of onabotulinumtoxinA Dose 2 injected into muscles of the study limb on fulfillment of the retreatment criteria. Receives: Biological: onabotulinumtoxinA |
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 Treated Muscle Groups Using a 6-Point Scale
Measured: Baseline, Up to 60 Weeks
Secondary outcomes (3)
Clinical Global Impression (CGI) of Overall Change by Physician Compared to Baseline Using a 9-Point Scale
Measured: Baseline, Up to 60 Weeks
Change from Baseline in Pain on an 11-Point Scale
Measured: Baseline, Up to 60 Weeks
Change from Baseline in the 19-Item Spasticity Impact Assessment-Upper Limb (SIA-UL) Score
Measured: Baseline, Up to 60 Weeks
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 startAug 2014
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Why it stopped: The study was withdrawn prior to enrollment due to corporate decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 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
- NCT02145689
- Sponsor's protocol ID
- 191622-129
- Other IDs
- 2013-002327-42
- Status last verified
- Aug 2014
- First submitted
- 21 May 2014
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Study of OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity
- ClinicalTrials.gov ID
- NCT02145689
- Acronym / sponsor ID
- 191622-129
- Conditions
- Muscle Spasticity, Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn prior to enrollment due to corporate decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 23 May 2014 (estimated)
- Results
- Not posted in the source record
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 long-term 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
- 2
| Arm | Type | Receives |
|---|---|---|
| onabotulinumtoxinA Dose 1 | Experimental | Biological: onabotulinumtoxinAUp to 4 treatments of onabotulinumtoxinA Dose 1 injected into muscles of the study limb on fulfillment of the retreatment criteria. |
| onabotulinumtoxinA Dose 2 | Experimental | Biological: onabotulinumtoxinAUp to 4 treatments of onabotulinumtoxinA Dose 2 injected into muscles of the study limb on fulfillment of the retreatment criteria. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For patients entering from the 191622-127 study, successful completion of study 191622-127
- For patients entering directly into study 191622-129, 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 AUp to 4 treatments of onabotulinumtoxinA injected into muscles of the study limb on fulfillment of the retreatment criteria. | Biological | onabotulinumtoxinA Dose 1, onabotulinumtoxinA Dose 2 |
Primary outcome
Change from Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Treated Muscle Groups Using a 6-Point Scale
Time frame: Baseline, Up to 60 Weeks
3 secondary outcomes
Clinical Global Impression (CGI) of Overall Change by Physician Compared to Baseline Using a 9-Point Scale
Time frame: Baseline, Up to 60 Weeks
Change from Baseline in Pain on an 11-Point Scale
Time frame: Baseline, Up to 60 Weeks
Change from Baseline in the 19-Item Spasticity Impact Assessment-Upper Limb (SIA-UL) Score
Time frame: Baseline, Up to 60 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
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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
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.
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 2 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: withdrawn, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 Treated Muscle Groups Using a 6-Point Scale (time frame: Baseline, Up to 60 Weeks). 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 13 Aug 2014.