Muscle SpasticityPhase 4NCT01256021
The Efficacy and Safety of MEDITOXIN® in Children With Cerebral Palsy
A Phase 4 study testing Botulinum Toxin Type A in people with Muscle Spasticity, run by Medy-Tox at 4 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Muscle Spasticity
- What is being tested?
- Botulinum Toxin Type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Aug 2010to May 2011
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients aged between 2 and 18 years with diagnosis of spastic cerebral palsy
- Patients with toe-walking due to peroneal muscle spasticity (patients with equinus foot deformity due to spasticity)
- Patients who voluntarily consent to participate in this study and whose legally acceptable representative has signed the informed consent form (if the patient is able to write, his/her signature should be also obtained).
Who cannot join
- Patients who had previously received botulinum toxin within 3 months prior to the study entry
- Patients with known hypersensitivity to botulinum toxin
- Patients who requires legs, feet or ankle surgery at present
- Patients with severe athetoid movement
- Patients who is participating in other investigational study at present
- Patients, by the investigator's discretion, who are not suitable for this study.
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Seoul National University Bundang Hospital
Seongnam
Seoul National Universtiy Hospital
Seoul, 110-744
Asan Medical Center
Seoul
Yonsei University Severance Hospital
Seoul
About this study
Official title: Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Safety and Efficacy of MEDITOXIN® in Children With Cerebral Palsy
The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of children with cerebral palsy.
Read the detailed description
The allocated subject is injected Meditoxin® 4U/kg body weight(for patients with hemiplegia) or 6U/kg body weight(for patients with diplegia)in the affected gastrocnemius muscle for the treatment of patients who suffer Equinus Foot Deformity with pediatric cerebral palsy due to spasticity.
The efficacy and safety are evaluated for 12weeks through 3 follow up visits.
- Conditions
- Muscle Spasticity
- Being tested
- Botulinum Toxin Type A
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Neuronox®, Siax®
1 time, gastrocnemius muscles injection, dose of 4U/kg body weight in patients with hemiplegia, dose of 6U/kg body weight in patients with diplegia, Maximum dosage 200U
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | Meditoxin Receives: Drug: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in MAS score from baseline to week 4
The investigator assessed MAS score using a 5-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) The "+1" (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 2
Measured: 4 weeks
Secondary outcomes (4)
Mean change from baseline in MAS score from baseline to week 12
The investigator assessed MAS score using a 5-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) The "+1" (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 2
Measured: 12 weeks
Mean change from baseline in PROM(Passive Range of Motion of ankle) at ankle dorsiflexion from baseline to week 4, 12
Measured: 4, 12 Weeks
Mean change from baseline in VAS(Visual Analogue Scale)assessed by caregiver/patient from baseline to week4
Individual goals of treatment were chosen one among pain, ease of care, standing, walking. The VAS used in this study is a straight 10cm horizontal line with anchor points of very satisfied (score 0)and very dissatisfied (score 10).
Measured: 4, 12 weeks
Improvement in Global Assessment assessed by caregiver/patient
Measured: 4, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2011
- Study completionMay 2011
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eun S Park, Ph D, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256021
- Sponsor's protocol ID
- MT_PRT_CP02
- Status last verified
- Mar 2019
- First submitted
- 6 Dec 2010
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Safety and Efficacy of MEDITOXIN® in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01256021
- Acronym / sponsor ID
- MT_PRT_CP02
- Conditions
- Muscle Spasticity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 8 Dec 2010 (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 purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of children with cerebral palsy.
Detailed description
The allocated subject is injected Meditoxin® 4U/kg body weight(for patients with hemiplegia) or 6U/kg body weight(for patients with diplegia)in the affected gastrocnemius muscle for the treatment of patients who suffer Equinus Foot Deformity with pediatric cerebral palsy due to spasticity.
The efficacy and safety are evaluated for 12weeks through 3 follow up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Experimental | Drug: Botulinum Toxin Type AMeditoxin |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pediatric patients aged between 2 and 18 years with diagnosis of spastic cerebral palsy
- Patients with toe-walking due to peroneal muscle spasticity (patients with equinus foot deformity due to spasticity)
- Patients who voluntarily consent to participate in this study and whose legally acceptable representative has signed the informed consent form (if the patient is able to write, his/her signature should be also obtained).
Key exclusion criteria (6 listed)
- Patients who had previously received botulinum toxin within 3 months prior to the study entry
- Patients with known hypersensitivity to botulinum toxin
- Patients who requires legs, feet or ankle surgery at present
- Patients with severe athetoid movement
- Patients who is participating in other investigational study at present
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 |
|---|---|---|
| Botulinum Toxin Type AAlso: Neuronox®, Siax®1 time, gastrocnemius muscles injection, dose of 4U/kg body weight in patients with hemiplegia, dose of 6U/kg body weight in patients with diplegia, Maximum dosage 200U | Drug | Treatment Group 1 |
Primary outcome
Mean change from baseline in MAS score from baseline to week 4
Time frame: 4 weeks
The investigator assessed MAS score using a 5-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part[s] rigid in flexion or extension) The "+1" (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder [less than half] of ROM [range of motion]) of MAS score is regarded as score 2
4 secondary outcomes
Mean change from baseline in MAS score from baseline to week 12
Time frame: 12 weeks
Mean change from baseline in PROM(Passive Range of Motion of ankle) at ankle dorsiflexion from baseline to week 4, 12
Time frame: 4, 12 Weeks
Mean change from baseline in VAS(Visual Analogue Scale)assessed by caregiver/patient from baseline to week4
Time frame: 4, 12 weeks
Improvement in Global Assessment assessed by caregiver/patient
Time frame: 4, 12 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 27 Mar 2019.
Related trials for Muscle Spasticity
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
RecruitingPhase 4
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
Not yet recruitingEarly Phase 1
Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence
Spasticity, Stroke
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.
Eun S Park, Ph D principal investigator
Severance Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin Type A in people with Muscle Spasticity, run by Medy-Tox at 4 sites 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 3 inclusion and 6 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 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 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?
Mean change from baseline in MAS score from baseline to week 4 (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 27 Mar 2019.