Phase 3 N=220 Treatment

BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity

Pediatrics · Muscle Spasticity · Cerebral Palsy · Stroke

Bottom Line

View on ClinicalTrials.gov: NCT01603615 ↗

Enrolled (actual)

220

Serious AEs

6.1%

Results posted

Aug 2019

Primary outcome: Primary: Percentage of Participants With at Least One Treatment- Emergent Adverse Event (TEAE) — 58.7 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Botulinum Toxin Type A (Biological)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With at Least One Treatment- Emergent Adverse Event (TEAE)	58.7	—

Summary

This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric upper limb spasticity.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01603615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.