CompletedPhase 3

BOTOX® Treatment in Pediatric Upper Limb Spasticity

United States235 participantsStarted 2012-07-12

Plain-language summary

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with upper limb spasticity.

Who can participate

Age range2 Years – 16 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 kg/22 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 6 months * Previous surgical treatment of the study limb (except tendon lengthening), or planned surgery of the study limb during the study * Previous casting of the study limb for spasticity within 6 months or with a dynamic splint within 3 months, or planned casting or dynamic splinting for spasticity of the study limb or affected lower limb during the study

What they're measuring

Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group at Weeks 4 and 6

Timeframe: Baseline (Day 1) to Weeks 4 and 6

Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6

Timeframe: Weeks 4 and 6

Trial details

NCT IDNCT01603602

SponsorAllergan

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06-29

Results submitted2018-06-12

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