Muscle SpasticityPhase 3NCT03289702
CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase3)
A Phase 3 study testing CORETOX® and BOTOX® in people with Muscle Spasticity, run by Medy-Tox at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of CORETOX® in the treatment of post-stroke upper limb spasticity Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Muscle Spasticity
- What is being tested?
- CORETOX® and BOTOX®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Nov 2017to 9 Nov 2018
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥ 19 years
- ≥ 6 months since the last stroke
- ≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of elbow flexor and finger flexor as measured on MAS(0 to 4)
- Informed consent has been obtained
Who cannot join
- Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
- History(within 4 months of screening visit) or planned(during study period) treatment with phenol or alcohol injection or surgery in the target limb
- History(within 4 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb
- Fixed joint/muscle contracture
- Severe atrophy
- Concurrent treatment with an intrathecal baclofen
Show all 15Show fewer
- Patients who have bleeding tendency or taking anti-coagulant
- Dysphagia and Breathing Difficulties
- History(within 4 months of screening visit) Planned(during study period) treatment with Botulinum Toxin
- Known allergy or sensitivity to study medication or its components
- Concurrent or planed Muscle relaxants and/or benzodiazepine medication If patient has taken these medication stable from one month before screening and no treatment changes are not planned during the study, participation is allowed.
- Current Physical, occupational, Splinting therapy These therapy regimens will be permitted if they have been stable in the one month before screening; no treatment and no changes are planned during the study.
- Patient who are participating in other clinical trials at the screening
- Females who are pregnant, breastfeeding, or planning a pregnancy during the study period, or female of childbearing potential, not using a reliable means of contraception.
- Patients who are not eligible for this study at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Active Drug Controlled, Multi-Center, Phase I/III Clinical Trial to Evaluate the Efficacy and Safety of CORETOX® in Treatment of Post Stroke Upper Limb Spasticity
The purpose of this study is to evaluate the efficacy and safety of CORETOX® in the treatment of post-stroke upper limb spasticity
- Conditions
- Muscle Spasticity
- Being tested
- CORETOX®, BOTOX®
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORETOX®Drug
Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.
BOTOX®Drug
Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U.
| Study group | Role | What they receive |
|---|---|---|
| CORETOX® | Experimental | Not described Receives: Drug: CORETOX® |
| BOTOX® | Active comparator | Not described Receives: Drug: BOTOX® |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAS(Modified Ashworth Scale)of wrist flexor
Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale)
Measured: 4 weeks
Secondary outcomes (3)
MAS(modified Ashworth Score)of elbow and finger flexor
Change from baseline at week 4 for elbow flexor and finger flexor muscle tone as measured on MAS
Measured: 4 weeks after injection
MAS(modified Ashworth Score)of wrist, elbow and finger flexor
Change from baseline at week 8, 12 for wrist flexor, elbow flexor and finger flexor muscle tone as measured on MAS
Measured: 8, 12 weeks after injection
Percentage of treatment responder at week 4, 8, 12 after injection
A treatment response is defined as 1-point improvement on the MAS of injection site
Measured: 4, 8, 12 weeks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start13 Nov 2017
- Primary completion30 Jun 2018
- Study completion9 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 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
- NCT03289702
- Sponsor's protocol ID
- MT03-KR16MST907 (Phase3)
- Status last verified
- Dec 2021
- First submitted
- 19 Sep 2017
- Last updated
- 7 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee J, Chun MH, Ko YJ, Lee SU, Kim DY, Paik NJ, Kwon BS, Park YG. Efficacy and Safety of MT10107 (Coretox) in Poststroke Upper Limb Spasticity Treatment: A Randomized, Double-Blind, Active Drug-Controlled, Multicenter, Phase III Clinical Trial. Arch Phys Med Rehabil. 2020 Sep;101(9):1485-1496. doi: 10.1016/j.apmr.2020.03.025. Epub 2020 Jun 1.
PubMed 32497599
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active Drug Controlled, Multi-Center, Phase I/III Clinical Trial to Evaluate the Efficacy and Safety of CORETOX® in Treatment of Post Stroke Upper Limb Spasticity
- ClinicalTrials.gov ID
- NCT03289702
- Acronym / sponsor ID
- MT03-KR16MST907 (Phase3)
- Conditions
- Muscle Spasticity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 9 Nov 2018 (actual)
- First posted
- 21 Sep 2017 (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.
The purpose of this study is to evaluate the efficacy and safety of CORETOX® in the treatment of post-stroke upper limb spasticity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CORETOX® | Experimental | Drug: CORETOX® |
| BOTOX® | Active comparator | Drug: BOTOX® |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients ≥ 19 years
- ≥ 6 months since the last stroke
- ≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of elbow flexor and finger flexor as measured on MAS(0 to 4)
- Informed consent has been obtained
Key exclusion criteria (15 listed)
- Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
- History(within 4 months of screening visit) or planned(during study period) treatment with phenol or alcohol injection or surgery in the target limb
- History(within 4 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb
- Fixed joint/muscle contracture
- Severe atrophy
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 |
|---|---|---|
| CORETOX®Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U. | Drug | CORETOX® |
| BOTOX®Upper limb will be injected and evaluated in the study. Maximum injection dose is 360U. | Drug | BOTOX® |
Primary outcome
MAS(Modified Ashworth Scale)of wrist flexor
Time frame: 4 weeks
Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale)
3 secondary outcomes
MAS(modified Ashworth Score)of elbow and finger flexor
Time frame: 4 weeks after injection
MAS(modified Ashworth Score)of wrist, elbow and finger flexor
Time frame: 8, 12 weeks after injection
Percentage of treatment responder at week 4, 8, 12 after injection
Time frame: 4, 8, 12 weeks after injection
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 7 Dec 2021.
- Derived from this study: PubMed 32497599Lee J, Chun MH, Ko YJ, Lee SU, Kim DY, Paik NJ, Kwon BS, Park YG. Efficacy and Safety of MT10107 (Coretox) in Poststroke Upper Limb Spasticity Treatment: A Randomized, Double-Blind, Active Drug-Controlled, Multicenter, Phase III Clinical Trial. Arch Phys Med Rehabil. 2020 Sep;101(9):1485-1496. doi: 10.1016/j.apmr.2020.03.025. Epub 2020 Jun 1.
- Individual participant dataSharing planned: Undecided
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Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
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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.
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 CORETOX® and BOTOX® in people with Muscle Spasticity, run by Medy-Tox at 1 site in South Korea.
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 15 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 7 Dec 2021. 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 South Korea. 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?
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?
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?
On the ClinicalTrials.gov record for NCT03289702, which also lists 1 linked publication.
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 7 Dec 2021.