BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity
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|ClinicalTrials.gov Identifier: NCT01603641|
Recruitment Status : Completed
First Posted : May 22, 2012
Results First Posted : August 21, 2019
Last Update Posted : August 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pediatrics Muscle Spasticity Cerebral Palsy||Biological: Botulinum Toxin Type A||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||370 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||BOTOX® Treatment in Pediatric Lower Limb Spasticity: Open-label Study|
|Actual Study Start Date :||November 5, 2012|
|Actual Primary Completion Date :||August 25, 2018|
|Actual Study Completion Date :||August 25, 2018|
Participants received maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into a single lower limb muscles or divided between both lower limb muscles or into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment not to exceed a maximum of 8 unit per kilogram (U/kg) of body weight (not to exceed 300 U) in treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 or 8 U/kg into the lower limb in the previous study or were de novo participants who were not enrolled in the previous study.
Biological: Botulinum Toxin Type A
Participants received intramuscular injections of botulinum toxin Type A into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.
- Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) [ Time Frame: From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks) ]An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603641
|Study Director:||Emily McCusker||Allergan|