Study of Intramuscular Injections of OnabotulinumtoxinA to Assess Change in Disease Activity in Pediatric Participants With Spasticity Associated With Cerebral Palsy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| OnabotulinumtoxinA Participants will receive OnabotulinumtoxinA as prescribed by their physician. |
Outcome Measures
Primary Outcome Measures
- Absolute Total Dose [Up to 12 months]
OnabotulinumtoxinA total dose applied at visit will be assessed.
- Total Dose Per Kilogram [Up to 12 months]
OnabotulinumtoxinA total dose applied at each visit, divided by patient's body weight will be assessed.
- Dose Per Muscle [Up to 12 months]
OnabotulinumtoxinA dose applied to each muscle, regardless of punctures' number on that muscle will be assessed.
- Application Sites Number Per Muscle [Up to 12 months]
Number of puncture sites per muscle will be assessed.
- Re-administration Interval [Up to 12 months]
Re-administration interval is defined as number of days between drug application and previous application.
- Needle Gauge [Up to 12 months]
Needle gauge is defined as diameter of needle thickness with which study treatment is applied.
- Needle Length [Up to 12 months]
Needle length is defined as distance from the needle base to the needle bevel tip.
- Preventive Pain Management Technique [Up to 12 months]
Type of method used to control procedural pain will be assessed.
- Method to Locate Application Site [Up to 12 months]
Type of method used to identify muscle and treatment application site will be assessed.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Unilateral/bilateral, upper/lower limb spasticity associated with cerebral palsy.
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Naïve to OnabotulinumtoxinA treatment and who, according to medical and to the standard clinical practice criteria, will receive OnabotulinumtoxinA.
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Treated only with stable doses of short-acting muscle relaxants can be included in the study, at the investigator's discretion, for at least 30 days prior to treatment starting, under the concept that at the time the steady state of the drug (stable plasma concentrations) will theoretically have been reached.
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Under adjuvant treatment with orthoses and other orthopedic devices can be included in the study.
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Participants with physio/physical therapy can be included.
Exclusion Criteria:
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Previously treated with botulinum toxin for spasticity related to cerebral palsy.
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Diagnosed with Eaton-Lambert syndrome, myasthenia gravis, or other neurological diseases with compromised neuromuscular transmission.
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History of hypersensitivity to the study drug or to any of the excipients in the formulation.
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Evidence of inflammation or infection in the anatomical region selected by the investigator for the study drug administration.
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Participants under treatment with drugs that interfere with neuromuscular transmission which, at the investigator's discretion, contraindicate OnabotulinumtoxinA concomitant administration.
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Have had orthopedic surgery in the segment to be infiltrated in the 12 months prior to drug application.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital General ISSSTE Tacuba /ID# 261460 | Ciudad de México | Ciudad De Mexico | Mexico | 11410 |
| 2 | Hospital General ISSSTE Tacuba /ID# 261932 | Ciudad de México | Ciudad De Mexico | Mexico | 11410 |
| 3 | Hospital General Regional 180 IMSS /ID# 261458 | Guadalajara | Jalisco | Mexico | 45653 |
| 4 | Hospital Militar De Zona De Villahermosa /ID# 261451 | Villahermosa | Tabasco | Mexico | 86100 |
| 5 | Cri Dif Jalisco /Id# 261459 | Guadalajara | Mexico | 44270 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: ABBVIE INC., AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- P24-430