Treatment With Xeomin Versus Botox in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy (XEBEC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02188277 |
Recruitment Status :
Completed
First Posted : July 11, 2014
Last Update Posted : January 26, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
- 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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cerebral Palsy Spastic Paraplegia and Hemiparesis Equine and Equinovarus Foot Deformation | Drug: Xeomin Drug: Botox® | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | July 2014 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Xeomin®
4-8 Units per kg body weight. Single injection cycle.
|
Drug: Xeomin
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. Other Names:
|
Active Comparator: Botox®
4-6(8) Units per kg body weight. Single injection cycle.
|
Drug: Botox®
Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius.
Other Name: OnabotulinumtoxinA |
- 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).
- 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 ]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.
- 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 ]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.
- Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale [ Time Frame: Baseline up to day 90 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.).
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188277
Russian Federation | |
State Budget Institution of Health in Moscow "Scientific and Practical Center of Pediatric psychoneurology Moscow Health Department" | |
Moscow, Russian Federation, 119602 | |
Federal State Autonomous Institution "Scientific Center of Children's Health" of the Ministry of Health of the Russian Federation | |
Moscow, Russian Federation, 119991 | |
Federal State Budget Educational Institution of Higher Professional Learning "Stavropol State Medical University" of the Ministry of Health of the Russian Federation | |
Stavropol, Russian Federation, 355017 |
Study Director: | Merz Medical Expert | LLC Merz Pharma, Russia |
Responsible Party: | Merz Pharmaceuticals GmbH |
ClinicalTrials.gov Identifier: | NCT02188277 |
Other Study ID Numbers: |
MRZ-R-201212_01001_N_2 |
First Posted: | July 11, 2014 Key Record Dates |
Last Update Posted: | January 26, 2017 |
Last Verified: | January 2017 |
Muscle Spasticity Clubfoot Talipes Equinus Deformity Cerebral Palsy Paresis Paraplegia Paralysis Neurologic Manifestations Nervous System Diseases Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Muscular Diseases Musculoskeletal Diseases |
Muscle Hypertonia Neuromuscular Manifestations Foot Deformities, Acquired Foot Deformities Foot Deformities, Congenital Lower Extremity Deformities, Congenital Limb Deformities, Congenital Musculoskeletal Abnormalities Congenital Abnormalities Botulinum Toxins Botulinum Toxins, Type A abobotulinumtoxinA incobotulinumtoxinA Acetylcholine Release Inhibitors Membrane Transport Modulators |