CompletedPhase 3

BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity

United States220 participantsStarted 2012-10-30

Plain-language summary

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

Who can participate

Age range2 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of Participants With at Least One Treatment- Emergent Adverse Event (TEAE)

Timeframe: From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)

Trial details

NCT IDNCT01603615

SponsorAllergan

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-09-03

Results submitted2019-07-29

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