Botulinum toxin type A(Botox®)
DrugSingle administration, 4units/kg body weight dose in patients with hemiplegia, 6units/kg body weight dose in patients with diplegia, Maximum dosage 200units
NCT Number: NCT01787344
To compare the safety and efficacy of Botulax Inj.®(Botulinum toxin type A, Hugel, South Korea) with Botox Inj.® (Botulinum toxin type A, Allergan, USA) in the treatment of cerebral palsy in children.
Looking for future studies?
Notify Me2 year–10 year
All sexes
Interventional
Phase 3
St. Vincent's hospital, Suwon, Kyunggi, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single administration, 4units/kg body weight dose in patients with hemiplegia, 6units/kg body weight dose in patients with diplegia, Maximum dosage 200units
Single administration, 4units/kg body weight dose in patients with hemiplegia,6units/kg body weight dose in patients with diplegia, Maximum dosage 200units
Time frame: at 12 weeks post-injection
Time frame: at 6 and 24weeks post-injection
Time frame: at 6, 12 and 24 weeks post-injection
Time frame: at 6, 12 and 24 weeks post-injection
Time frame: at 6, 12 and 24 weeks post-injection
Hugel
Industry
Double-blinded, Randomized, Active Control Comparative, Multicenter-designed, Phase III Clinical Trial to Evaluate the Safety and Efficacy of "Botulax®" Versus "Botox®" in Children With Cerebral Palsy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.