Cerebral Palsy (CP)Phase 3NCT06840158
Double-blind Comparative Randomized Multicenter
A Phase 3 study testing Miotox (Botulinum toxin type A is a hemagglutinin complex) and BOTOX® in people with Cerebral Palsy (CP), run by Innopharm LLC at 3 sites in Russia.
Trial summary
The name of the study: is a double-blind comparative randomized trial to evaluate the safety and efficacy of the drug Miotox® with the participation of children with cerebral palsy The code/number of the Protocol No. MTK-III-D-cerebral palsy-04/2019, version 5.0 dated 09/01/2021. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Miotox (Botulinum toxin type A is a hemagglutinin complex) and BOTOX®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesRussia
- Study dates
- 15 Oct 2021to 29 Jun 2022
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients were checked for compliance with the following inclusion criteria:
- Written and dated Informed consent of the child's parent to participate in the clinical trial; The age of the child is from 2 to 12 years (2 years 0 months 0 days - 11 years 11 months 29 days);
- Focal spasticity associated with dynamic foot deformity of the "horse foot" type due to spasticity in children with cerebral palsy undergoing outpatient treatment;
- The degree of spasticity on the modified Ashworth scale (MAS) 2 or more;
- Grade level on the scale of basic motor functions for cerebral palsy, extended and refined version (GMFCS - E\&R) I - III;
- Children and their parents who are able to fulfill the requirements of the Protocol (i.e., fill out a self-observation diary, come to control visits).
Who cannot join
- During the study, patients were excluded if any of the following criteria were present:
- Withdrawal of Informed consent by the patient's parent;
- Serious adverse events or adverse events that do not meet the criteria of severity, in the development of which, in the opinion of the researcher, further participation in the study may be detrimental to the health or well-being of the patient;
- The need for procedures and/or drug treatment that are not permitted by the Protocol of this study;
- The patient was included in violation of the criteria for inclusion/non-inclusion of the Protocol;
- The appearance of non-inclusion criteria during the study;
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- The need for surgical intervention.
- The patient's incompetence with the examination procedures.
- Any condition of the patient that requires, in the reasonable opinion of the research physician, the withdrawal of the patient from the study;
- The patient refuses to cooperate or is undisciplined (for example, the patient does not show up for a scheduled visit without warning the researcher and/or loss of communication with the patient);
- The patient is out of observation;
- Non-compliance by the patient with the established Protocol requirements, rules of stay at the clinical base; For administrative reasons (termination of the study by the Sponsor or regulatory authorities), as well as in case of gross violations of the Protocol that may affect the results of the study.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
SPb GBUZ "DGP No. 45 of the Nevsky district
Saint Petersburg
GBUZ SODKB named after N.N. Ivanova, Candidate of Medical Sciences;
Samara
Limited Liability Company "Santerra" (LLC "Santerra")
Stavropol
About this study
Official title: A Double-blind Comparative Randomized Trial to Evaluate the Safety and Efficacy of the Drug Miotox® in Children with Cerebral Palsy
The name of the study: is a double-blind comparative randomized trial to evaluate the safety and efficacy of the drug Miotox® with the participation of children with cerebral palsy The code/number of the Protocol No. MTK-III-D-cerebral palsy-04/2019, version 5.0 dated 09/01/2021.
Investigational drug Trade Name: Miotox®. Description: Transparent or slightly opalescent liquid from colorless to light yellow. Manufacturer: FSBI "M.P. Chumakov FNCRIP RAS", Russia Comparison drug: Trade Name: Botox® Description: dried white substance in the form of a barely noticeable film located at the bottom of the bottle. Manufacturer: Allergan Pharmaceuticals Ireland, Ireland.
The studied indication for use is Focal spasticity associated with dynamic foot deformity of the "horse foot" type due to spasticity in patients 2 years and older with cerebral palsy who are on outpatient treatment Study design Double-blind comparative randomized multicenter The sponsor of the study is Innopharm LLC, Russia Clinical Development: Phase III The start date of the study is 10/15/2021. The date of completion of the study is 06/29/2022.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Miotox (Botulinum toxin type A is a hemagglutinin complex), BOTOX®
- Keywords
- botulinum toxin
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miotox (Botulinum toxin type A is a hemagglutinin complex)Drug
During the study, patients were injected with the investigational drug Miotox® .
For the treatment of spasticity and equine varus deformity of the foot in children with cerebral palsy, drugs were injected into two points of each head of the calf muscle (medial and lateral). In case of damage to one limb, the total dose was 4 units / kg of body weight per affected limb. In diplegia, the total dose was 6 units / kg of body weight for both affected limbs. The total total dose should not exceed 200 units.
This course of treatment is based on the current instructions for the medical use of Botox®.
BOTOX®Drug
During the study, patients were injected with the investigational comparison drug Botox®.
For the treatment of spasticity and equine varus deformity of the foot in children with cerebral palsy, drugs were injected into two points of each head of the calf muscle (medial and lateral). In case of damage to one limb, the total dose was 4 units / kg of body weight per affected limb. In diplegia, the total dose was 6 units / kg of body weight for both affected limbs. The total total dose should not exceed 200 units.
This course of treatment is based on the current instructions for the medical use of Botox®.
| Study group | Role | What they receive |
|---|---|---|
| Miotox®(Botulinum toxin type A is a hemagglutinin complex) | Experimental | Children of the younger age group from 2 to 12 years (2 years 0 months 0 days - 11 years 11 months 29 days) Group 1 - 40 children who were injected with the drug Miotox®; Receives: Drug: Miotox (Botulinum toxin type A is a hemagglutinin complex) |
| Botox (Botulinum toxin type A - hemagglutinin complex - 100 units) | Active comparator | Children of the younger age group from 2 to 12 years (2 years 0 months 0 days - 11 years 11 months 29 days) Group 2 - 40 children who were injected with Botox®. Receives: Drug: BOTOX® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment
The frequency of adverse events during the study:
adverse events of an immediate type (allergic reactions) that occur within 2 hours after administration of the drug under study and identified both by the researcher and according to information provided to the researcher by the patient's parent; adverse events (local and systemic reactions) that occur within 7 days after administration of the test drug and are identified according to information provided to the researcher by the patient's parent; other adverse events that occur 7 days after administration of the test drug (from 8 to 84 days after administration of the test drug, without taking into account the permissible interval of visits) and noted by the patient's parent in the Self-observation Diary.
Measured: 14 weeks
Efficasy assessment
The change in the level of spasticity (decrease in score) on the Modified Ashworth Scale (MAS) scale at week 4 compared to the baseline level from 1 to 4 points.
Measured: 14 weeks
Secondary outcomes (7)
Safety assessment
The frequency of serious adverse events during the study.
Measured: 14 weeks
Safety assessment
The frequency of adverse events and serious adverse events, at least probably related to the study drug during the study.
Measured: 14 weeks
Safety assessment
Cases of early termination of patients' participation in the study due to the development of NYA/NYA associated with the use of research drugs.
Measured: 14 weeks
Efficasy assessment
Change in the level of spasticity on the Modified Ashworth Scale (MAS) scale (decrease in score) at 1, 8 and 12 weeks compared to the baseline level.
Measured: 14 weeks
Efficasy assessment
Severity of pain on a 10-point Visual Analogue Scale (VAS) at 1, 4, 8 and 12 weeks compared to the baseline level (decrease in pain severity).
Measured: 14 weeks
Efficasy assessment
The state of motor functions according to the scale of basic motor functions for cerebral palsy (GMFCS - E\&R) at 1, 4, 8 and 12 weeks compared with the baseline level.
Measured: 14 weeks
Efficasy assessment
Measurement of spasticity on the Mental Toughness Scale (MTS )(decrease in score) at 1, 4, 8 and 12 weeks compared to the baseline level.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start15 Oct 2021
- Primary completion15 May 2022
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innopharm LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840158
- Sponsor's protocol ID
- № MTK-III-D-DCP-04/2019
- Status last verified
- Feb 2025
- First submitted
- 27 Jan 2025
- Last updated
- 21 Feb 2025
- 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 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Comparative Randomized Trial to Evaluate the Safety and Efficacy of the Drug Miotox® in Children with Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06840158
- Acronym / sponsor ID
- № MTK-III-D-DCP-04/2019
- Conditions
- Cerebral Palsy (CP)
- Keywords
- botulinum toxin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Innopharm LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 21 Feb 2025 (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 name of the study: is a double-blind comparative randomized trial to evaluate the safety and efficacy of the drug Miotox® with the participation of children with cerebral palsy The code/number of the Protocol No. MTK-III-D-cerebral palsy-04/2019, version 5.0 dated 09/01/2021.
Investigational drug Trade Name: Miotox®. Description: Transparent or slightly opalescent liquid from colorless to light yellow. Manufacturer: FSBI "M.P. Chumakov FNCRIP RAS", Russia Comparison drug: Trade Name: Botox® Description: dried white substance in the form of a barely noticeable film located at the bottom of the bottle. Manufacturer: Allergan Pharmaceuticals Ireland, Ireland.
The studied indication for use is Focal spasticity associated with dynamic foot deformity of the "horse foot" type due to spasticity in patients 2 years and older with cerebral palsy who are on outpatient treatment Study design Double-blind comparative randomized multicenter The sponsor of the study is Innopharm LLC, Russia Clinical Development: Phase III The start date of the study is 10/15/2021. The date of completion of the study is 06/29/2022.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miotox®(Botulinum toxin type A is a hemagglutinin complex) | Experimental | Drug: Miotox (Botulinum toxin type A is a hemagglutinin complex)Children of the younger age group from 2 to 12 years (2 years 0 months 0 days - 11 years 11 months 29 days) Group 1 - 40 children who were injected with the drug Miotox®; |
| Botox (Botulinum toxin type A - hemagglutinin complex - 100 units) | Active comparator | Drug: BOTOX®Children of the younger age group from 2 to 12 years (2 years 0 months 0 days - 11 years 11 months 29 days) Group 2 - 40 children who were injected with Botox®. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Written and dated Informed consent of the child's parent to participate in the clinical trial; The age of the child is from 2 to 12 years (2 years 0 months 0 days - 11 years 11 months 29 days);
- Focal spasticity associated with dynamic foot deformity of the "horse foot" type due to spasticity in children with cerebral palsy undergoing outpatient treatment;
- The degree of spasticity on the modified Ashworth scale (MAS) 2 or more;
- Grade level on the scale of basic motor functions for cerebral palsy, extended and refined version (GMFCS - E\&R) I - III;
- Children and their parents who are able to fulfill the requirements of the Protocol (i.e., fill out a self-observation diary, come to control visits).
Key exclusion criteria (12 listed)
- Withdrawal of Informed consent by the patient's parent;
- Serious adverse events or adverse events that do not meet the criteria of severity, in the development of which, in the opinion of the researcher, further participation in the study may be detrimental to the health or well-being of the patient;
- The need for procedures and/or drug treatment that are not permitted by the Protocol of this study;
- The patient was included in violation of the criteria for inclusion/non-inclusion of the Protocol;
- The appearance of non-inclusion criteria during the study;
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 |
|---|---|---|
| Miotox (Botulinum toxin type A is a hemagglutinin complex)During the study, patients were injected with the investigational drug Miotox® . For the treatment of spasticity and equine varus deformity of the foot in children with cerebral palsy, drugs were injected into two points of each head of the calf muscle (medial and lateral). In case of damage to one limb, the total dose was 4 units / kg of body weight per affected limb. In diplegia, the total dose was 6 units / kg of body weight for both affected limbs. The total total dose should not exceed 200 units. This course of treatment is based on the current instructions for the medical use of Botox®. | Drug | Miotox®(Botulinum toxin type A is a hemagglutinin complex) |
| BOTOX®During the study, patients were injected with the investigational comparison drug Botox®. For the treatment of spasticity and equine varus deformity of the foot in children with cerebral palsy, drugs were injected into two points of each head of the calf muscle (medial and lateral). In case of damage to one limb, the total dose was 4 units / kg of body weight per affected limb. In diplegia, the total dose was 6 units / kg of body weight for both affected limbs. The total total dose should not exceed 200 units. This course of treatment is based on the current instructions for the medical use of Botox®. | Drug | Botox (Botulinum toxin type A - hemagglutinin complex - 100 units) |
Primary outcome
Safety assessment
Time frame: 14 weeks
The frequency of adverse events during the study: adverse events of an immediate type (allergic reactions) that occur within 2 hours after administration of the drug under study and identified both by the researcher and according to information provided to the researcher by the patient's parent; adverse events (local and systemic reactions) that occur within 7 days after administration of the test drug and are identified according to information provided to the researcher by the patient's parent; other adverse events that occur 7 days after administration of the test drug (from 8 to 84 days after administration of the test drug, without taking into account the permissible interval of visits) and noted by the patient's parent in the Self-observation Diary.
Efficasy assessment
Time frame: 14 weeks
The change in the level of spasticity (decrease in score) on the Modified Ashworth Scale (MAS) scale at week 4 compared to the baseline level from 1 to 4 points.
7 secondary outcomes
Safety assessment
Time frame: 14 weeks
Safety assessment
Time frame: 14 weeks
Safety assessment
Time frame: 14 weeks
Efficasy assessment
Time frame: 14 weeks
Efficasy assessment
Time frame: 14 weeks
Efficasy assessment
Time frame: 14 weeks
Efficasy assessment
Time frame: 14 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 21 Feb 2025.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Miotox (Botulinum toxin type A is a hemagglutinin complex) and BOTOX® in people with Cerebral Palsy (CP), run by Innopharm LLC at 3 sites in Russia.
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 6 inclusion and 12 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 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. 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?
Safety assessment (time frame: 14 weeks). The study lists 2 primary outcomes in all. 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 21 Feb 2025.