BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity

July 29, 2019 updated by: Allergan

BOTOX® Treatment in Pediatric Lower Limb Spasticity: Open-label Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

370

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1113
        • Semmelweis Egyetem- Ortopédiai Klinika Karolina út 27
      • Debrecen, Hungary, 4032
        • Debrecen University Clinical Center, Orthopedic Clinic
  • Italy
      • Genoa, Italy, 16148
        • Istituto IRCCS G. Salini
  • Korea, Republic of
      • Daegu, Korea, Republic of, 41199
        • Daegu fatima hospital
      • Gyeonggi-do, Korea, Republic of, 10444
        • National Health Insurance Service Ilsan Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
  • Philippines
      • Quezon City, Philippines, 1102
        • St. Luke's Medical Center
      • Quezon City, Philippines, 1100
        • Philippine Orthopedic Center
      • Quezon City, Philippines, 1104
        • Philippine Children's Medical Center
  • Poland
      • Białystok, Poland, 15-274
        • Uniwersytecki Dzieciecy Szpita
      • Gdansk, Poland, 80-219
        • Uniwersyteckie Centrum Kliniczne
      • Gdansk, Poland, 80-389
        • Centrum Rehabilitacji Krok po Kroku
      • Krakow, Poland, 30-539
        • Specjalistyczny Gabinet Neurologiczny
      • Lodz, Poland, 93-271
        • Centrum Medyczne "POMOC"
      • Lublin, Poland, 20-058
        • INTERMED, Lublin
      • Lublin, Poland, 20-601
        • CRH ŻAGIEL MED, Lublin
      • Rzeszow, Poland, 35-301
        • Szpital Wojewodzki Nr 2
      • Warsaw, Poland, 05-462
        • NZOZ Mazowieckie Centrum
      • Warsaw, Poland, 02-315
        • Poradnia Rehab - Neurologiczneij dla Dzieci I Mlodziezy Aga
  • Russian Federation
      • Kazan, Russian Federation, 420138
        • Childrens Republic Hospital
      • Smolensk, Russian Federation, 214018
        • Smolensk Regional Hospital- Regional Budget State Healthcare institution
      • Tyumen, Russian Federation, 625039
        • Tyumen Regional Hospital #2 - State Budget Healthcare Institution of Tyumen region
  • Thailand
      • ChiangMai, Thailand, 50200
        • Maharaj Nakorn Chiangmai Hospital
      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital, Khon Kaen University
  • Turkey
      • Ankara, Turkey, 6110
        • Ankara Diskapi Yildrim Beyazit
      • Kocaeli, Turkey, 41050
        • Kocaeli Üniversitesi
      • Konya, Turkey, 42250
        • Selçuk Üniversitesi
  • United States
    • California
      • Pasadena, California, United States, 91106
        • ABS Health, LLC
      • Pomona, California, United States, 91767
        • Harrison Clinical Management
      • San Diego, California, United States, 92123
        • Rady Children's Hospital San Diego
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Associated Neurologists of Southern Connecticut, P.C.
      • Stamford, Connecticut, United States, 06905
        • New England Institute for Clinical Research
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • NW FL Clinical Research Group, LLC
      • Loxahatchee Groves, Florida, United States, 33470
        • Axcess Medical Research, LLC
      • Orlando, Florida, United States, 32819
        • Pediatric Neurology, P.A.
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Children's Healthcare of Atlanta Children's Rehabilitation Associates
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Shirley Ryan Ability Lab
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Children's Hospital Pediatric Research
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • The Children's Mercy Hospital
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Clinical Research Center Of New Jersey
    • New York
      • New York, New York, United States, 10003
        • NYU Hospital for Joint Diseases
      • New York, New York, United States, 10032
        • Columbia University Dept. of Rehab. & Regenerative Medicine
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • OnSite Clinical Solutions, LLC
      • Charlotte, North Carolina, United States, 28203
        • PMG Research of Charlotte, LLC
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Hasbro Children's Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine Texas Children's Hospital
      • San Antonio, Texas, United States, 78249
        • Road Runner Research
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Minimum weight of 10 kilograms (kg)/22 pounds (lb)
  • Cerebral palsy with dynamic muscle contracture of the ankle

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 lower study leg within 1 year, or planned surgery of any limb during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BOTOX®
Participants received maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into a single lower limb muscles or divided between both lower limb muscles or into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment not to exceed a maximum of 8 unit per kilogram (U/kg) of body weight (not to exceed 300 U) in treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 or 8 U/kg into the lower limb in the previous study or were de novo participants who were not enrolled in the previous study.
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.
Other Names:
  • OnabotulinumtoxinA
  • BOTOX®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Time Frame: From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period.
From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2012

Primary Completion (Actual)

August 25, 2018

Study Completion (Actual)

August 25, 2018

Study Registration Dates

First Submitted

May 21, 2012

First Submitted That Met QC Criteria

May 21, 2012

First Posted (Estimate)

May 22, 2012

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191622-112
  • 2012-000084-24 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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