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BOTOX® Treatment in Pediatric Lower Limb Spasticity

NCT01603628 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2018-08-14

Study results available
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Summary

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

Conditions

  • Pediatrics
  • Muscle Spasticity
  • Cerebral Palsy

Interventions

DRUG

Normal Saline (Placebo)

Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb on Day 1.

BIOLOGICAL

botulinum toxin Type A

Participants received intramuscular injections of botulinum toxin Type A into specified muscles of the lower limb on Day 1.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Rozalina Dimitrova · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-11
Primary Completion
2017-06-28
Completion
2017-06-28

Countries

  • United States
  • Hungary
  • Italy
  • Philippines
  • Poland
  • Russia
  • South Korea
  • Thailand
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01603628 on ClinicalTrials.gov