Muscle SpasticityPhase 1NCT05164003
CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase1)
A Phase 1 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 safety and pharmacodynamic 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®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jul 2017to 29 Sep 2017
- Phase
- Phase 1
- 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
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- 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 safety and pharmacodynamic 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
Up to a total of 360U of the IP was allowed to be injected at three flexors; wrist, elbow and finger.
BOTOX®Drug
Up to a total of 360U of the comparator was allowed to be injected at three flexors; wrist, elbow and finger.
| 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.
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) Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)
Measured: 4 weeks
Secondary outcomes (3)
Modified Ashworth Scale of elbow and finger flexor
Change from baseline at week 4 for elbow flexor and finger flexor muscle tone as measured on MAS Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)
Measured: 4 weeks after the injection
Modified Ashworth Scale 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 Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)
Measured: 8 and 12 weeks after the injection
Modified Ashworth Scale of wrist, elbow and finger flexor
The responder rate of wrist, elbow, and finger flexor tone at week 4, 8 and 12 if the responder rate is defined as at least 1-point decrease in MAS score after IP administration.
Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)
Measured: 4, 8 and 12 weeks after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start17 Jul 2017
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT05164003
- Sponsor's protocol ID
- MT03-KR16MST907 (Phase1)
- Status last verified
- Dec 2021
- First submitted
- 5 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- 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 11 Jan 2022. 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
- NCT05164003
- Acronym / sponsor ID
- MT03-KR16MST907 (Phase1)
- Conditions
- Muscle Spasticity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 20 Dec 2021 (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 safety and pharmacodynamic 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
- 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®Up to a total of 360U of the IP was allowed to be injected at three flexors; wrist, elbow and finger. | Drug | CORETOX® |
| BOTOX®Up to a total of 360U of the comparator was allowed to be injected at three flexors; wrist, elbow and finger. | Drug | BOTOX® |
Primary outcome
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) Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)
3 secondary outcomes
Modified Ashworth Scale of elbow and finger flexor
Time frame: 4 weeks after the injection
Modified Ashworth Scale of wrist, elbow and finger flexor
Time frame: 8 and 12 weeks after the injection
Modified Ashworth Scale of wrist, elbow and finger flexor
Time frame: 4, 8 and 12 weeks after the 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 11 Jan 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Muscle Spasticity
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Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
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Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
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Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence
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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 1 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 11 Jan 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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 11 Jan 2022.