Status:
COMPLETED
Study of Intramuscular Injections of OnabotulinumtoxinA to Assess Change in Disease Activity in Pediatric Participants With Spasticity Associated With Cerebral Palsy
Lead Sponsor:
AbbVie
Conditions:
Spasticity
Eligibility:
All Genders
2-17 years
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. ...
Eligibility Criteria
Inclusion
- Unilateral/bilateral, upper/lower limb spasticity associated with cerebral palsy.
- Naïve to OnabotulinumtoxinA treatment and who, according to medical and to the standard clinical practice criteria, will receive OnabotulinumtoxinA.
- 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.
- Under adjuvant treatment with orthoses and other orthopedic devices can be included in the study.
- Participants with physio/physical therapy can be included.
Exclusion
- Previously treated with botulinum toxin for spasticity related to cerebral palsy.
- Diagnosed with Eaton-Lambert syndrome, myasthenia gravis, or other neurological diseases with compromised neuromuscular transmission.
- History of hypersensitivity to the study drug or to any of the excipients in the formulation.
- Evidence of inflammation or infection in the anatomical region selected by the investigator for the study drug administration.
- Participants under treatment with drugs that interfere with neuromuscular transmission which, at the investigator's discretion, contraindicate OnabotulinumtoxinA concomitant administration.
- Have had orthopedic surgery in the segment to be infiltrated in the 12 months prior to drug application.
Key Trial Info
Start Date :
September 8 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT06150729
Start Date
September 8 2023
End Date
May 30 2025
Last Update
July 2 2025
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital General Regional 180 IMSS /ID# 261458
Guadalajara, Jalisco, Mexico, 45653
2
Clinica de Rehabilitacion Integral Yupi /Id# 261461
Puerto Vallarta, Jalisco, Mexico, 48312
3
Hospital General ISSSTE Tacuba /ID# 261460
Mexico City, Mexico City, Mexico, 11410
4
Hospital General ISSSTE Tacuba /ID# 261932
Mexico City, Mexico City, Mexico, 11410