Phase
Condition
Limb Spasticity
Dystonia
Cerebral Palsy
Treatment
N/AClinical Study ID
Ages 2-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Unilateral/bilateral, upper/lower limb spasticity associated with cerebral palsy.
Naïve to OnabotulinumtoxinA treatment and who, according to medical and to thestandard clinical practice criteria, will receive OnabotulinumtoxinA.
Treated only with stable doses of short-acting muscle relaxants can be included inthe study, at the investigator's discretion, for at least 30 days prior to treatmentstarting, under the concept that at the time the steady state of the drug (stableplasma concentrations) will theoretically have been reached.
Under adjuvant treatment with orthoses and other orthopedic devices can be includedin the study.
Participants with physio/physical therapy can be included.
Exclusion
Exclusion Criteria:
Previously treated with botulinum toxin for spasticity related to cerebral palsy.
Diagnosed with Eaton-Lambert syndrome, myasthenia gravis, or other neurologicaldiseases with compromised neuromuscular transmission.
History of hypersensitivity to the study drug or to any of the excipients in theformulation.
Evidence of inflammation or infection in the anatomical region selected by theinvestigator for the study drug administration.
Participants under treatment with drugs that interfere with neuromusculartransmission which, at the investigator's discretion, contraindicateOnabotulinumtoxinA concomitant administration.
Have had orthopedic surgery in the segment to be infiltrated in the 12 months priorto drug application.
Study Design
Connect with a study center
Hospital General ISSSTE Tacuba /ID# 261460
Ciudad de México, Ciudad De Mexico 11410
MexicoSite Not Available
Hospital General ISSSTE Tacuba /ID# 261932
Ciudad de México, Ciudad De Mexico 11410
MexicoSite Not Available
Hospital General Regional 180 IMSS /ID# 261458
Guadalajara, Jalisco 45653
MexicoSite Not Available
Hospital Militar De Zona De Villahermosa /ID# 261451
Villahermosa, Tabasco 86100
MexicoSite Not Available
Cri Dif Jalisco /Id# 261459
Guadalajara, 44270
MexicoSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.