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Spasticity is often observed as muscle tightness and stiffness in the upper and/or lower limbs. Upper limb spasticity can interfere with joint movement and its severity can range from mild to severe. This study will assess how effective OnabotulinumtoxinA is in treating pediatric participants with Spasticity. Change in disease activity will be evaluated.
OnabotulinumtoxinA is approved drug for treatment of Spasticity. Approximately 106 pediatric participants aged 2-17 years with spasticity associated with cerebral palsy will be enrolled in approximately 10 sites across Mexico.
Participants will receive OnabotulinumtoxinA as prescribed by their physician in accordance to local label and followed for 12 months.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits to a hospital or clinic in their routine practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OnabotulinumtoxinA | Participants will receive OnabotulinumtoxinA as prescribed by their physician. |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute Total Dose | OnabotulinumtoxinA total dose applied at visit will be assessed. | Up to 12 months |
| Total Dose Per Kilogram | OnabotulinumtoxinA total dose applied at each visit, divided by patient's body weight will be assessed. | Up to 12 months |
| Dose Per Muscle | OnabotulinumtoxinA dose applied to each muscle, regardless of punctures' number on that muscle will be assessed. | Up to 12 months |
| Application Sites Number Per Muscle | Number of puncture sites per muscle will be assessed. | Up to 12 months |
| Re-administration Interval | Re-administration interval is defined as number of days between drug application and previous application. | Up to 12 months |
| Needle Gauge | Needle gauge is defined as diameter of needle thickness with which study treatment is applied. | Up to 12 months |
| Needle Length | Needle length is defined as distance from the needle base to the needle bevel tip. | Up to 12 months |
| Preventive Pain Management Technique |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric Participants (2-17 years) with spasticity associated with cerebral palsy.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Regional 180 IMSS /ID# 261458 | Guadalajara | Jalisco | 45653 | Mexico | ||
| Clinica de Rehabilitacion Integral Yupi /Id# 261461 |
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Type of method used to control procedural pain will be assessed.
| Up to 12 months |
| Method to Locate Application Site | Type of method used to identify muscle and treatment application site will be assessed. | Up to 12 months |
| Puerto Vallarta |
| Jalisco |
| 48312 |
| Mexico |
| Hospital General ISSSTE Tacuba /ID# 261460 | Mexico City | Mexico City | 11410 | Mexico |
| Hospital General ISSSTE Tacuba /ID# 261932 | Mexico City | Mexico City | 11410 | Mexico |
| Cree Dif Nuevo Leon /Id# 261454 | Monterrey, Nuevo LEON | Nuevo León | 64790 | Mexico |
| Hospital Militar De Zona De Villahermosa /ID# 261451 | Villahermosa | Tabasco | 86100 | Mexico |
| Cri Dif Jalisco /Id# 261459 | Guadalajara | 44270 | Mexico |
| Crit Estado de México /Id# 261934 | Tlalnepantla | 54010 | Mexico |
| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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