Cerebral Palsy, Muscle Spasticity, Pediatrics, Stroke
Conditions
Brief summary
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric upper limb spasticity.
Interventions
BIOLOGICALBotulinum Toxin Type A
Participants received intramuscular injections of botulinum Toxin Type A in the upper and/or lower limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Minimum weight of 10 Kilograms (kg) / 22 Pounds (lb) * Upper limb spasticity due to cerebral palsy or stroke
Exclusion criteria
* Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or mitochondrial disease * Uncontrolled epilepsy * Botulinum Toxin therapy of any serotype for any condition within the last 3 months * History of surgical intervention of the upper limb within 1 year, or planned surgery of any limb during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least One Treatment- Emergent Adverse Event (TEAE) | 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. Safety population included all treated participants. |
Countries
Canada, Hungary, Philippines, Poland, Russia, South Korea, Thailand, Turkey (Türkiye), United States
Participant flow
Pre-assignment details
Pediatric participants with Upper Limb Spasticity who were previously treated with BOTOX® in study 191622-101 \[NCT01603602\] and de novo participants received up to 5 BOTOX® treatments in this study.
Participants by arm
| Arm | Count |
|---|---|
| BOTOX® Participants received a maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into upper limb and/or lower limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment, de novo participants received at least 6 U/kg of body weight or a maximum of 8 U/kg of body weight (not to exceed 300 U). Rollover participants received up to a maximum of 8 U/kg of body weight (not to exceed 300 U) for treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Rolled over participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 or 6 U/kg into upper limb in previous study or were de novo participants who were not enrolled in previous study. | 213 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not Receive Treatment | 7 |
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Other Miscellaneous | 1 |
| Overall Study | Personal Reasons | 17 |
Baseline characteristics
| Characteristic | BOTOX® |
|---|---|
| Age, Continuous | 8.3 years STANDARD_DEVIATION 4.1 |
| Race/Ethnicity, Customized Asian | 61 Participants |
| Race/Ethnicity, Customized Black | 9 Participants |
| Race/Ethnicity, Customized Hispanic | 10 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized White | 130 Participants |
| Sex: Female, Male Female | 85 Participants |
| Sex: Female, Male Male | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 213 |
| other Total, other adverse events | 57 / 213 |
| serious Total, serious adverse events | 13 / 213 |
Outcome results
Primary
Percentage of Participants With at Least One Treatment- Emergent Adverse Event (TEAE)
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. Safety population included all treated participants.
Time frame: From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)
Population: Safety population included all treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BOTOX® | Percentage of Participants With at Least One Treatment- Emergent Adverse Event (TEAE) | 58.7 percentage of participants |