Muscle SpasticityPhase 4NCT02757404
Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity
A Phase 4 study testing Ultrasonography guidance injection of Meditoxin®., Electrical stimulation guidance injection of Meditoxin®. and Manual needle placement injection of Meditoxin®. in people with Muscle Spasticity, run by Medy-Tox.
Trial summary
Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Muscle Spasticity
- What is being tested?
- Ultrasonography guidance injection of Meditoxin®., Electrical stimulation guidance injection of Meditoxin®. and Manual needle placement injection of Meditoxin®.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2016to 16 Aug 2016
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject aged over 20.
- Subjects who has grade 1 + and more spasticity at least one of upper limb muscles as measured on Modified Ashworth Scale after stroke.
- Subjects who was diagnosed stroke at least 1 month prior to study participation.
- Subjects or legal representatives who voluntarily decided the participation of the study and signed the informed consent.
Who cannot join
- Subjects who had spinal injuries to be a factor of spasticity except for stroke prior to study enrollment.
- Subjects with allergy or hypersensitivity to the Botulinum Toxin.
- Subjects who have changed the muscle relaxant taking for treatment within past 4 weeks prior to study participation.
- Subjects who have taken injection treatments using alcohol or phenol in upper limb within past 6 months prior to study participation.
- Subjects with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis).
- Subjects who have been injected with botulinum toxin within past 3 months before the injection.
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- Subjects who are pregnant or lactating of disagreed to avoid pregnancy during 3 months study period.
- Subjects who are scheduled to take part in other clinical trial during the study period.
- Patients who are not eligible for this study at the medical discretion of the investigator.
About this study
Official title: Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity
Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity.
Read the detailed description
This study is "A Multicenter, Prospective, Randomized, Evaluator Blinded, Comparing Phase 4 Study to Evaluate the Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity".
- Conditions
- Muscle Spasticity
- Being tested
- Ultrasonography guidance injection of Meditoxin®., Electrical stimulation guidance injection of Meditoxin®., Manual needle placement injection of Meditoxin®.
- Keywords
- botulinum toxin, spasticity, injection technique, neuronox, meditoxin
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography guidance injection of Meditoxin®.Drug
Meditoxin® will be injected to upper limb spasticity by using the ultrasonography guidance.
Electrical stimulation guidance injection of Meditoxin®.Drug
Meditoxin® will be injected to upper limb spasticity by using the electrical stimulation guidance.
Manual needle placement injection of Meditoxin®.Drug
Meditoxin® will be injected to upper limb spasticity by using the manual needle placement.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonography guidance | Experimental | Ultrasonography guidance injection of Meditoxin®. Receives: Drug: Ultrasonography guidance injection of Meditoxin®. |
| Electrical stimulation guidance | Experimental | Electrical stimulation guidance injection of Meditoxin®. Receives: Drug: Electrical stimulation guidance injection of Meditoxin®. |
| Manual needle placement | Experimental | Manual needle placement injection of Meditoxin®. Receives: Drug: Manual needle placement injection of Meditoxin®. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms.
Measured: 4 weeks
Secondary outcomes (2)
Comparison evaluation on improvement rate of spasticity assessed by Modified Tardieu Scale between 3 arms.
Measured: 4 weeks
Comparison evaluation on improvement rate of range of motion on each joint between 3 arms.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study start30 May 2016
- Primary completion16 Aug 2016
- Study completion16 Aug 2016
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MyungEun Chung, Principal investigator, St. Paul's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757404
- Sponsor's protocol ID
- MT_PRT_ST04
- Status last verified
- Mar 2019
- First submitted
- 25 Apr 2016
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity
- ClinicalTrials.gov ID
- NCT02757404
- Acronym / sponsor ID
- MT_PRT_ST04
- Conditions
- Muscle Spasticity
- Keywords
- botulinum toxin, spasticity, injection technique, neuronox, meditoxin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 30 May 2016 (actual)
- Primary completion
- 16 Aug 2016 (actual)
- Study completion
- 16 Aug 2016 (actual)
- First posted
- 2 May 2016 (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.
Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity.
Detailed description
This study is "A Multicenter, Prospective, Randomized, Evaluator Blinded, Comparing Phase 4 Study to Evaluate the Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultrasonography guidance | Experimental | Drug: Ultrasonography guidance injection of Meditoxin®.Ultrasonography guidance injection of Meditoxin®. |
| Electrical stimulation guidance | Experimental | Drug: Electrical stimulation guidance injection of Meditoxin®.Electrical stimulation guidance injection of Meditoxin®. |
| Manual needle placement | Experimental | Drug: Manual needle placement injection of Meditoxin®.Manual needle placement injection of Meditoxin®. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subject aged over 20.
- Subjects who has grade 1 + and more spasticity at least one of upper limb muscles as measured on Modified Ashworth Scale after stroke.
- Subjects who was diagnosed stroke at least 1 month prior to study participation.
- Subjects or legal representatives who voluntarily decided the participation of the study and signed the informed consent.
Key exclusion criteria (9 listed)
- Subjects who had spinal injuries to be a factor of spasticity except for stroke prior to study enrollment.
- Subjects with allergy or hypersensitivity to the Botulinum Toxin.
- Subjects who have changed the muscle relaxant taking for treatment within past 4 weeks prior to study participation.
- Subjects who have taken injection treatments using alcohol or phenol in upper limb within past 6 months prior to study participation.
- Subjects with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis).
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 |
|---|---|---|
| Ultrasonography guidance injection of Meditoxin®.Meditoxin® will be injected to upper limb spasticity by using the ultrasonography guidance. | Drug | Ultrasonography guidance |
| Electrical stimulation guidance injection of Meditoxin®.Meditoxin® will be injected to upper limb spasticity by using the electrical stimulation guidance. | Drug | Electrical stimulation guidance |
| Manual needle placement injection of Meditoxin®.Meditoxin® will be injected to upper limb spasticity by using the manual needle placement. | Drug | Manual needle placement |
Primary outcome
Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms.
Time frame: 4 weeks
2 secondary outcomes
Comparison evaluation on improvement rate of spasticity assessed by Modified Tardieu Scale between 3 arms.
Time frame: 4 weeks
Comparison evaluation on improvement rate of range of motion on each joint between 3 arms.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Muscle Spasticity
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Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
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Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
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Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
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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.
MyungEun Chung principal investigator
St. Paul's Hospital, The Catholic University of Korea
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ultrasonography guidance injection of Meditoxin®., Electrical stimulation guidance injection of Meditoxin®. and Manual needle placement injection of Meditoxin®. in people with Muscle Spasticity, run by Medy-Tox.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 29 Mar 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms. (time frame: 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 29 Mar 2019.