StrokePhase 3NCT02580838
The Effects of Early and Late Injection of Botulinum Toxin Type A on Upper Limb Function in Patients With Stroke
A Phase 3 study testing OnabotulinumtoxinA in people with Stroke, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The aim of this study is to determine whether early use of OnabotulinumtoxinA is more effective to improve functional outcomes of upper limb in patients with stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- OnabotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2015to Sep 2025
- 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
- stroke affecting one body side
- spasticity develops after stroke
Who cannot join
- musculoskeletal conditions that affected upper limb function prior to stroke
- concurrent use of anti-spasticity medications
- patients with neuromuscular junction or myopathic disorders such as myasthenia gravis or others
- patients with a known allergy to any onabotulinumtoxinA or to any of the excipients of onabotulinumtoxinA (such as human serum albumin)
- patients who are pregnant or may become pregnant at the time of the proposed injection
Trial locations and contacts
1 site in 1 country.
Richard Lin contact
Taiwan1 site, 1 recruiting
- Recruiting
Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital
Tainan, 138
Richard Lin, Tel: 886-6-2353535 ext. 2666, richelin@mail.ncku.edu.tw
About this study
The aim of this study is to determine whether early use of OnabotulinumtoxinA is more effective to improve functional outcomes of upper limb in patients with stroke.
Read the detailed description
Many patients surviving stroke have significant impairment of function in the affected upper limb due to the development of spasticity. Botulinum toxin type A injection is a powerful treatment option for control of spasticity. In this study, the patients will be randomly assigned into three groups: early OnabotulinumtoxinA group will receive OnabotulinumtoxinA injection when their spasticity develop, late OnabotulinumtoxinA group will have injection at 6 months after emergence of spasticity, the third group will not have OnabotulinumtoxinA intervention. The aim of this randomized controlled study is to evaluate the effects of early and late injection of botulinum toxin type A on upper limb function in patients with stroke.
- Conditions
- Stroke
- Being tested
- OnabotulinumtoxinA
- Keywords
- Stroke, Spasticity, OnabotulinumtoxinA
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinADrug
Also called Botox
Early OnabotulinumtoxinA group will receive OnabotulinumtoxinA injection when their spasticity develop, late OnabotulinumtoxinA group will have injection at 6 months after emergence of spasticity, the third group will not have OnabotulinumtoxinA intervention.
| Study group | Role | What they receive |
|---|---|---|
| early OnabotulinumtoxinA group | Experimental | OnabotulinumtoxinA will be injected immediately when spasticity develop in early OnabotulinumtoxinA group. Receives: Drug: OnabotulinumtoxinA |
| late OnabotulinumtoxinA group | Active comparator | OnabotulinumtoxinA will be injected at 6 months after emergence of spasticity in late OnabotulinumtoxinA group. Receives: Drug: OnabotulinumtoxinA |
| no OnabotulinumtoxinA group | No intervention | OnabotulinumtoxinA will not be injected for this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
Measured: change from baseline Modified Ashworth Scale at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2023 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Lin, Principal investigator, Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580838
- Sponsor's protocol ID
- B-BR-102-032
- Status last verified
- Oct 2015
- First submitted
- 11 Oct 2015
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Early and Late Injection of Botulinum Toxin Type A on Upper Limb Function in Patients With Stroke
- ClinicalTrials.gov ID
- NCT02580838
- Acronym / sponsor ID
- B-BR-102-032
- Conditions
- Stroke
- Keywords
- Stroke, Spasticity, OnabotulinumtoxinA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 20 Oct 2015 (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.
The aim of this study is to determine whether early use of OnabotulinumtoxinA is more effective to improve functional outcomes of upper limb in patients with stroke.
Detailed description
Many patients surviving stroke have significant impairment of function in the affected upper limb due to the development of spasticity. Botulinum toxin type A injection is a powerful treatment option for control of spasticity. In this study, the patients will be randomly assigned into three groups: early OnabotulinumtoxinA group will receive OnabotulinumtoxinA injection when their spasticity develop, late OnabotulinumtoxinA group will have injection at 6 months after emergence of spasticity, the third group will not have OnabotulinumtoxinA intervention. The aim of this randomized controlled study is to evaluate the effects of early and late injection of botulinum toxin type A on upper limb function in patients with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| early OnabotulinumtoxinA group | Experimental | Drug: OnabotulinumtoxinAOnabotulinumtoxinA will be injected immediately when spasticity develop in early OnabotulinumtoxinA group. |
| late OnabotulinumtoxinA group | Active comparator | Drug: OnabotulinumtoxinAOnabotulinumtoxinA will be injected at 6 months after emergence of spasticity in late OnabotulinumtoxinA group. |
| no OnabotulinumtoxinA group | No intervention | –OnabotulinumtoxinA will not be injected for this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stroke affecting one body side
- spasticity develops after stroke
Key exclusion criteria (5 listed)
- musculoskeletal conditions that affected upper limb function prior to stroke
- concurrent use of anti-spasticity medications
- patients with neuromuscular junction or myopathic disorders such as myasthenia gravis or others
- patients with a known allergy to any onabotulinumtoxinA or to any of the excipients of onabotulinumtoxinA (such as human serum albumin)
- patients who are pregnant or may become pregnant at the time of the proposed injection
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: BotoxEarly OnabotulinumtoxinA group will receive OnabotulinumtoxinA injection when their spasticity develop, late OnabotulinumtoxinA group will have injection at 6 months after emergence of spasticity, the third group will not have OnabotulinumtoxinA intervention. | Drug | early OnabotulinumtoxinA group, late OnabotulinumtoxinA group |
Primary outcome
Modified Ashworth Scale
Time frame: change from baseline Modified Ashworth Scale at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Richard Lin contact
Richard Lin principal investigator
Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital
1 site in 1 country: 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 Stroke, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 5 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: status not confirmed, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Lin (886-6-2353535 ext. 2666, richelin@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (time frame: change from baseline Modified Ashworth Scale at 4 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 30 Sep 2022.