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BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity

NCT01603641 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2019-08-21

Study results available
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Summary

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

Conditions

  • Pediatrics
  • Muscle Spasticity
  • Cerebral Palsy

Interventions

BIOLOGICAL

Botulinum Toxin Type A

Participants received intramuscular injections of botulinum toxin Type A into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Emily McCusker · Allergan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-11-05
Primary Completion
2018-08-25
Completion
2018-08-25

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 NCT01603641 on ClinicalTrials.gov