BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity
BOTOX® Treatment in Pediatric Lower Limb Spasticity: Open-label Study
2 other identifiers
interventional
370
9 countries
56
Brief Summary
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2012
Longer than P75 for phase_3
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2012
CompletedFirst Posted
Study publicly available on registry
May 22, 2012
CompletedStudy Start
First participant enrolled
November 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2018
CompletedResults Posted
Study results publicly available
August 21, 2019
CompletedAugust 21, 2019
July 1, 2019
5.8 years
May 21, 2012
July 29, 2019
July 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
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)
Study Arms (1)
BOTOX®
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Minimum weight of 10 kilograms (kg)/22 pounds (lb)
- Cerebral palsy with dynamic muscle contracture of the ankle
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (56)
ABS Health, LLC
Pasadena, California, 91106, United States
Harrison Clinical Management
Pomona, California, 91767, United States
Rady Children's Hospital San Diego
San Diego, California, 92123, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Associated Neurologists of Southern Connecticut, P.C.
Fairfield, Connecticut, 06824, United States
New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, 32561, United States
Axcess Medical Research, LLC
Loxahatchee Groves, Florida, 33470, United States
Pediatric Neurology, P.A.
Orlando, Florida, 32819, United States
Children's Healthcare of Atlanta Children's Rehabilitation Associates
Atlanta, Georgia, 30342, United States
Shirley Ryan Ability Lab
Chicago, Illinois, 60611, United States
Beaumont Children's Hospital Pediatric Research
Royal Oak, Michigan, 48073, United States
The Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Clinical Research Center of New Jersey
Voorhees Township, New Jersey, 08043, United States
NYU Hospital for Joint Diseases
New York, New York, 10003, United States
Columbia University Dept. of Rehab. & Regenerative Medicine
New York, New York, 10032, United States
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, 28203, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28203, United States
Hasbro Children's Hospital
Providence, Rhode Island, 02903, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine Texas Children's Hospital
Houston, Texas, 77030, United States
Road Runner Research
San Antonio, Texas, 78249, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Semmelweis Egyetem- Ortopédiai Klinika Karolina út 27
Budapest, 1113, Hungary
Debrecen University Clinical Center, Orthopedic Clinic
Debrecen, 4032, Hungary
Istituto IRCCS G. Salini
Genoa, 16148, Italy
Philippine Orthopedic Center
Quezon City, 1100, Philippines
St. Luke's Medical Center
Quezon City, 1102, Philippines
Philippine Children's Medical Center
Quezon City, 1104, Philippines
Uniwersytecki Dzieciecy Szpita
Bialystok, 15-274, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-219, Poland
Centrum Rehabilitacji Krok po Kroku
Gdansk, 80-389, Poland
Specjalistyczny Gabinet Neurologiczny
Krakow, 30-539, Poland
Centrum Medyczne "POMOC"
Lodz, 93-271, Poland
INTERMED, Lublin
Lublin, 20-058, Poland
CRH ŻAGIEL MED, Lublin
Lublin, 20-601, Poland
Szpital Wojewodzki Nr 2
Rzeszów, 35-301, Poland
Poradnia Rehab - Neurologiczneij dla Dzieci I Mlodziezy Aga
Warsaw, 02-315, Poland
NZOZ Mazowieckie Centrum
Warsaw, 05-462, Poland
Childrens Republic Hospital
Kazan', 420138, Russia
Smolensk Regional Hospital- Regional Budget State Healthcare institution
Smolensk, 214018, Russia
Tyumen Regional Hospital #2 - State Budget Healthcare Institution of Tyumen region
Tyumen, 625039, Russia
Daegu Fatima Hospital
Daegu, 41199, South Korea
National Health Insurance Service Ilsan Hospital
Gyeonggi-do, 10444, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Maharaj Nakorn ChiangMai Hospital
Chiang Mai, 50200, Thailand
Srinagarind Hospital, Khon Kaen University
Khon Kaen, 40002, Thailand
Ankara Diskapi Yildrim Beyazit
Ankara, 6110, Turkey (Türkiye)
Kocaeli Üniversitesi
Kocaeli, 41050, Turkey (Türkiye)
Selçuk Üniversitesi
Konya, 42250, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Emily McCusker
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2012
First Posted
May 22, 2012
Study Start
November 5, 2012
Primary Completion
August 25, 2018
Study Completion
August 25, 2018
Last Updated
August 21, 2019
Results First Posted
August 21, 2019
Record last verified: 2019-07