Cerebral PalsyPhase 2XEBECNCT02188277
Treatment With Xeomin Versus Botox in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy
A Phase 2 study testing Xeomin and Botox® in people with Cerebral Palsy and Spastic Paraplegia and Hemiparesis, run by Merz Pharmaceuticals GmbH at 3 sites in Russia.
Trial summary
1. To assess the clinical and neurophysiological efficacy of Xeomin® vs. Botox® in children with spastic equine and equinovarus foot deformation in pediatric cerebral palsy 2. To assess the safety of Xeomin® use as compared to Botox® in this patient population Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Cerebral Palsy, Spastic Paraplegia and Hemiparesis, Equine and Equinovarus Foot Deformation
- What is being tested?
- Xeomin and Botox®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesRussia
- Study dates
- Jul 2014to Dec 2016
- Phase
- Phase 2
- 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
- Children from 2 through 12 years of age, of both sexes, suffering from spastic paraplegia or hemiparesis in pediatric cerebral palsy.
- Equine and equinovarus foot posture.
- Gastrocnemius spasticity of 2 points and greater, by modified Ashworth scale.
- Patient can walk unassisted or with a support.
- Mental development of patients is normal or mildly retarded.
- Previous course of spasticity treatment with BTA products was completed earlier than at 6 months before this trial or never administered before.
- Patient's parents have signed an informed consent, are able and wishing to adhere to procedures described in the trial protocol and to the schedule of visits throughout the entire period of treatment.
Who cannot join
- Fixed ankle joint contracture.
- Previous denervation of spastic muscles by surgery, phenol or alcohol;
- Athetosis and dystonia in the area of injected muscles.
- Inflammation at the planned injection site.
- Elevated body temperature and acute (infectious and non-infectious) diseases at the time of injection.
- Neuromuscular transmission disorders (myasthenia gravis, Lambert-Eaton syndrome, etc.).
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- Decompensated physical diseases potentially affecting the trial findings.
- Acute fever, infection or surgery within 1 month before the trial.
- Use of aminoglycosides or spectinomycin within 1 month before starting the trial.
- Hypersensitivity to any of product ingredients.
- Positive history for allergies (especially with regard to protein-containing products).
- Patient's parents are unable or unwilling to adhere to the trial protocol requirements including signing the informed consent and conforming to the schedule of visits.
- Participation in other clinical trials in the last 4 weeks before inclusion.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
State Budget Institution of Health in Moscow "Scientific and Practical Center of Pediatric psychoneurology Moscow Health Department"
Moscow, 119602
Federal State Autonomous Institution "Scientific Center of Children's Health" of the Ministry of Health of the Russian Federation
Moscow, 119991
Federal State Budget Educational Institution of Higher Professional Learning "Stavropol State Medical University" of the Ministry of Health of the Russian Federation
Stavropol, 355017
About this study
Official title: Multi-center Open Comparative Randomized Trial of Clinical and Neurophysiological Efficacy and Safety of Xeomin (Botulinum Toxin Type A) vs. Botox (Complex of Botulinum Toxin Type A and Hemagglutinin) in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy
- To assess the clinical and neurophysiological efficacy of Xeomin® vs. Botox® in children with spastic equine and equinovarus foot deformation in pediatric cerebral palsy
- To assess the safety of Xeomin® use as compared to Botox® in this patient population
- Conditions
- Cerebral Palsy, Spastic Paraplegia and Hemiparesis, Equine and Equinovarus Foot Deformation
- Being tested
- Xeomin, Botox®
- Medical subject headings
- Cerebral Palsy, Paraplegia, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XeominDrug
Also called IncobotulinumtoxinA, NT 201, Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius.
Botox®Drug
Also called OnabotulinumtoxinA
Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius.
| Study group | Role | What they receive |
|---|---|---|
| Xeomin® | Experimental | 4-8 Units per kg body weight. Single injection cycle. Receives: Drug: Xeomin |
| Botox® | Active comparator | 4-6(8) Units per kg body weight. Single injection cycle. Receives: Drug: Botox® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale (AS)
The AS is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Measured: From baseline to day 30
Secondary outcomes (6)
Changes from baseline in patient percentage in groups by the degree of gastrocnemius spasticity according to modified Ashworth scale
Measured: From baseline up to day 90
Percentage of decrease in M-response magnitude and area recorded from the lateral and medial gastrocnemius heads, from baseline values
Electromyography: The amplitude of a compound muscle action potential (M-wave) is recorded. An electrical stimulation is considered supramaximal when the M-wave amplitude no longer increases while increasing the stimulus. The measurements include the M-wave amplitude and the negative peak area of the M-wave.
Measured: From baseline up to day 90
Changes from baseline in the ratio of M-response recorded from the lateral and medial gastrocnemius heads and from tibialis anterior
Measured: From baseline up to day 90
Changes from baseline in angles and angle ratio of ankle joints at passive and voluntary extension
Measured: From baseline up to day 90
Changes from baseline in motor activity according to Gross Motor Function Classification Systems (GMFCS) criteria
GMFCS is a 5-level classification system that is a standardized observational instrument for children with CP developed to measure change in gross motor function over time.
Measured: From baseline up to day 90
Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale
Measured: Baseline up to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LLC Merz Pharma, Russia
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, LLC Merz Pharma, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188277
- Sponsor's protocol ID
- MRZ-R-201212_01001_N_2
- Acronym
- XEBEC
- Status last verified
- Jan 2017
- First submitted
- 10 Jul 2014
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Open Comparative Randomized Trial of Clinical and Neurophysiological Efficacy and Safety of Xeomin (Botulinum Toxin Type A) vs. Botox (Complex of Botulinum Toxin Type A and Hemagglutinin) in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02188277
- Acronym / sponsor ID
- XEBEC / MRZ-R-201212_01001_N_2
- Conditions
- Cerebral Palsy, Spastic Paraplegia and Hemiparesis, Equine and Equinovarus Foot Deformation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Collaborators
- LLC Merz Pharma, Russia
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Jul 2014 (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.
- To assess the clinical and neurophysiological efficacy of Xeomin® vs. Botox® in children with spastic equine and equinovarus foot deformation in pediatric cerebral palsy
- To assess the safety of Xeomin® use as compared to Botox® in this patient population
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xeomin® | Experimental | Drug: Xeomin4-8 Units per kg body weight. Single injection cycle. |
| Botox® | Active comparator | Drug: Botox®4-6(8) Units per kg body weight. Single injection cycle. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children from 2 through 12 years of age, of both sexes, suffering from spastic paraplegia or hemiparesis in pediatric cerebral palsy.
- Equine and equinovarus foot posture.
- Gastrocnemius spasticity of 2 points and greater, by modified Ashworth scale.
- Patient can walk unassisted or with a support.
- Mental development of patients is normal or mildly retarded.
Key exclusion criteria (13 listed)
- Fixed ankle joint contracture.
- Previous denervation of spastic muscles by surgery, phenol or alcohol;
- Athetosis and dystonia in the area of injected muscles.
- Inflammation at the planned injection site.
- Elevated body temperature and acute (infectious and non-infectious) diseases at the time of injection.
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 |
|---|---|---|
| XeominAlso: IncobotulinumtoxinA, NT 201, Botulinum toxin type A (150 kiloDalton), free from complexing proteinsActive ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius. | Drug | Xeomin® |
| Botox®Also: OnabotulinumtoxinAAdministration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius. | Drug | Botox® |
Primary outcome
Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale (AS)
Time frame: From baseline to day 30
The AS is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
6 secondary outcomes
Changes from baseline in patient percentage in groups by the degree of gastrocnemius spasticity according to modified Ashworth scale
Time frame: From baseline up to day 90
Percentage of decrease in M-response magnitude and area recorded from the lateral and medial gastrocnemius heads, from baseline values
Time frame: From baseline up to day 90
Changes from baseline in the ratio of M-response recorded from the lateral and medial gastrocnemius heads and from tibialis anterior
Time frame: From baseline up to day 90
Changes from baseline in angles and angle ratio of ankle joints at passive and voluntary extension
Time frame: From baseline up to day 90
Changes from baseline in motor activity according to Gross Motor Function Classification Systems (GMFCS) criteria
Time frame: From baseline up to day 90
Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale
Time frame: Baseline up to day 90
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 26 Jan 2017.
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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.
Merz Medical Expert study director
LLC Merz Pharma, Russia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xeomin and Botox® in people with Cerebral Palsy and Spastic Paraplegia and Hemiparesis, run by Merz Pharmaceuticals GmbH 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 7 inclusion and 13 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 26 Jan 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale (AS) (time frame: From baseline to day 30). 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 26 Jan 2017.