Spasticity, MusclePhase 4NCT03908580
MEDITOXIN® Treatment in Subjects With Post-Stroke Upper Limb Spasticity
A Phase 4 study testing Meditoxin in people with Spasticity, Muscle, run by Medy-Tox.
Trial summary
This study is "A Prospective, Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Treatment of Post Stroke Upper Limb Spasticity". Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Spasticity, Muscle
- What is being tested?
- Meditoxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 6 Sep 2013to 31 Mar 2015
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female over 20 years.
- Subjects that was diagnosed with stroke at least 1 month before participating in the clinical trial.
- Subjects with MAS score of ≥2 for local muscle spasticity of wrist flexor.
Who cannot join
- Subjects with generalized neuromuscular junction disorder (ex: myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, etc.).
- Subjects with fixed joint, muscle contracture, or atrophy in the treatment area.
- Subjects with botulinum toxin treatment within 3 months before administration of the investigational product.
- Known immunization or hypersensitivity to any botulinum toxin preparations.
- Subjects who have recieved the following treatments within 4 weeks from screening: Muscle relaxants, Benzodiazepines, Aminoglycosides, Other antibiotics, Anticholinergics
About this study
Official title: A Prospective, Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Treatment of Post Stroke Upper Limb Spasticity
This study is "A Prospective, Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Treatment of Post Stroke Upper Limb Spasticity".
- Conditions
- Spasticity, Muscle
- Being tested
- 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.
MeditoxinDrug
Also called Neuronox®
Meditoxin® (Botulinum toxin type A) was injected up to 360 U.
| Study group | Role | What they receive |
|---|---|---|
| Meditoxin® | Experimental | Botulinum toxin type A was intramuscularly injected up to 360U and up to 4 sites, depending on the muscle size. Receives: Drug: Meditoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor
Change in muscle tone determined by MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) of wrist flexor in subjects with post stroke upper limb spasticity at week 4 after administration compared to baseline.
Measured: 4 weeks
Secondary outcomes (7)
Change in muscle tone determined by MAS (Modified Ashworth Scale) of elbow flexor and finger flexor
Change in muscle tone determined by MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) of elbow flexor and finger flexor at week 4 and 16 after administration compared to baseline, and at 4 weeks after re-administration compared to the time of re-visit.
Measured: 4 weeks, 16 weeks, and 4 weeks after re-visit
Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor
Change in muscle tone determined by MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) of wrist flexor at week 16 after administration compared to baseline, and at 4 weeks after re-administration compared to the time of re-visit.
Measured: 16 weeks, and 4 weeks after re-visit
The effective rate of wrist flexor, elbow flexor, and finger flexor
The effective rate of wrist flexor, elbow flexor, and finger flexor at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit, defining the muscle with MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) score of ≥1 among the wrist flexor, elbow flexor, and finger flexor muscles as responders when the MAS is reduced by 1 score compared to baseline (week 0).
Measured: 4 weeks, 16 weeks, and 4 weeks after re-visit
Change in DAS (Disability Assessment Scale) score
Change in score of goal assessment section in DAS (Disability Assessment Scale: Measures disability associated with upper limb spasticity in patients; score 0 to 3, 3 being the most severe disability) at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit.
Measured: 4 weeks, 16 weeks, and 4 weeks after re-visit
Change in QOL (SF-36v2; Quality of Life) score
Change in score of Short Form 36 ver.2 (SF-36v2; Quality of Life, QOL: a questionnaire with 36 questions regarding general health change affecting patient's quality of life; score from 1 up to 5, from minimum to high impact on quality of life) at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit.
Measured: 4 weeks, 16 weeks, and 4 weeks after re-visit
Subject's or caregiver's global assessment
Subject's or caregiver's global assessment (rating from -3 to +3 on the overall treatment effect, with +3 being very satisfied with treatment) at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit.
Measured: 4 weeks, 16 weeks, and 4 weeks after re-visit
Number of participants with Adverse Events (AEs) to assess safety of investigational product.
Safety of IP assessed by the number of partiicipants with adverse events determined by MedDra ver 16.0 from enrollment to the end of study.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start6 Sep 2013
- Primary completion31 Oct 2014
- Study completion31 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity, MuscleStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908580
- Sponsor's protocol ID
- MT_PRT_ST02
- Status last verified
- Apr 2019
- First submitted
- 26 Mar 2019
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Treatment of Post Stroke Upper Limb Spasticity
- ClinicalTrials.gov ID
- NCT03908580
- Acronym / sponsor ID
- MT_PRT_ST02
- Conditions
- Spasticity, Muscle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2013 (actual)
- Primary completion
- 31 Oct 2014 (actual)
- Study completion
- 31 Mar 2015 (actual)
- First posted
- 9 Apr 2019 (actual)
- 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 study is "A Prospective, Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Treatment of Post Stroke Upper Limb Spasticity".
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meditoxin® | Experimental | Drug: MeditoxinBotulinum toxin type A was intramuscularly injected up to 360U and up to 4 sites, depending on the muscle size. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female over 20 years.
- Subjects that was diagnosed with stroke at least 1 month before participating in the clinical trial.
- Subjects with MAS score of ≥2 for local muscle spasticity of wrist flexor.
Key exclusion criteria (5 listed)
- Subjects with generalized neuromuscular junction disorder (ex: myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, etc.).
- Subjects with fixed joint, muscle contracture, or atrophy in the treatment area.
- Subjects with botulinum toxin treatment within 3 months before administration of the investigational product.
- Known immunization or hypersensitivity to any botulinum toxin preparations.
- Subjects who have recieved the following treatments within 4 weeks from screening: Muscle relaxants, Benzodiazepines, Aminoglycosides, Other antibiotics, Anticholinergics
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 |
|---|---|---|
| MeditoxinAlso: Neuronox®Meditoxin® (Botulinum toxin type A) was injected up to 360 U. | Drug | Meditoxin® |
Primary outcome
Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor
Time frame: 4 weeks
Change in muscle tone determined by MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) of wrist flexor in subjects with post stroke upper limb spasticity at week 4 after administration compared to baseline.
7 secondary outcomes
Change in muscle tone determined by MAS (Modified Ashworth Scale) of elbow flexor and finger flexor
Time frame: 4 weeks, 16 weeks, and 4 weeks after re-visit
Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor
Time frame: 16 weeks, and 4 weeks after re-visit
The effective rate of wrist flexor, elbow flexor, and finger flexor
Time frame: 4 weeks, 16 weeks, and 4 weeks after re-visit
Change in DAS (Disability Assessment Scale) score
Time frame: 4 weeks, 16 weeks, and 4 weeks after re-visit
Change in QOL (SF-36v2; Quality of Life) score
Time frame: 4 weeks, 16 weeks, and 4 weeks after re-visit
Subject's or caregiver's global assessment
Time frame: 4 weeks, 16 weeks, and 4 weeks after re-visit
Number of participants with Adverse Events (AEs) to assess safety of investigational product.
Time frame: Through study completion, an average of 1 year
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 9 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meditoxin in people with Spasticity, Muscle, 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 3 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: finished, as of the sponsor's last update on 9 Apr 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?
Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor (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 9 Apr 2019.