BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity
- Conditions
- Muscle SpasticityCerebral PalsyPediatrics
- Interventions
- Biological: Botulinum Toxin Type A
- Registration Number
- NCT01603641
- Lead Sponsor
- Allergan
- Brief Summary
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 370
- Minimum weight of 10 kilograms (kg)/22 pounds (lb)
- Cerebral palsy with dynamic muscle contracture of the ankle
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BOTOX® Botulinum Toxin Type A 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (56)
The Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
St. Luke's Medical Center
🇵🇭Quezon City, Philippines
Uniwersytecki Dzieciecy Szpita
🇵🇱Białystok, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Philippine Children's Medical Center
🇵🇭Quezon City, Philippines
Centrum Rehabilitacji Krok po Kroku
🇵🇱Gdansk, Poland
Specjalistyczny Gabinet Neurologiczny
🇵🇱Krakow, Poland
Centrum Medyczne "POMOC"
🇵🇱Lodz, Poland
INTERMED, Lublin
🇵🇱Lublin, Poland
CRH ŻAGIEL MED, Lublin
🇵🇱Lublin, Poland
Szpital Wojewodzki Nr 2
🇵🇱Rzeszow, Poland
Poradnia Rehab - Neurologiczneij dla Dzieci I Mlodziezy Aga
🇵🇱Warsaw, Poland
NZOZ Mazowieckie Centrum
🇵🇱Warsaw, Poland
Maharaj Nakorn ChiangMai Hospital
🇹🇭ChiangMai, Thailand
Srinagarind Hospital, Khon Kaen University
🇹🇭Khon Kaen, Thailand
Clinical Research Center of New Jersey
🇺🇸Voorhees, New Jersey, United States
NW FL Clinical Research Group, LLC
🇺🇸Gulf Breeze, Florida, United States
Axcess Medical Research, LLC
🇺🇸Loxahatchee Groves, Florida, United States
ABS Health, LLC
🇺🇸Pasadena, California, United States
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Harrison Clinical Management
🇺🇸Pomona, California, United States
New England Institute for Clinical Research
🇺🇸Stamford, Connecticut, United States
Kocaeli Üniversitesi
🇹🇷Kocaeli, Turkey
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Associated Neurologists of Southern Connecticut, P.C.
🇺🇸Fairfield, Connecticut, United States
Selçuk Üniversitesi
🇹🇷Konya, Turkey
Tyumen Regional Hospital #2 - State Budget Healthcare Institution of Tyumen region
🇷🇺Tyumen, Russian Federation
Philippine Orthopedic Center
🇵🇭Quezon City, Philippines
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Ankara Diskapi Yildrim Beyazit
🇹🇷Ankara, Turkey
Childrens Republic Hospital
🇷🇺Kazan, Russian Federation
Smolensk Regional Hospital- Regional Budget State Healthcare institution
🇷🇺Smolensk, Russian Federation
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Shirley Ryan Ability Lab
🇺🇸Chicago, Illinois, United States
Children's Healthcare of Atlanta Children's Rehabilitation Associates
🇺🇸Atlanta, Georgia, United States
Pediatric Neurology, P.A.
🇺🇸Orlando, Florida, United States
Beaumont Children's Hospital Pediatric Research
🇺🇸Royal Oak, Michigan, United States
NYU Hospital for Joint Diseases
🇺🇸New York, New York, United States
OnSite Clinical Solutions, LLC
🇺🇸Charlotte, North Carolina, United States
Columbia University Dept. of Rehab. & Regenerative Medicine
🇺🇸New York, New York, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Semmelweis Egyetem- Ortopédiai Klinika Karolina út 27
🇭🇺Budapest, Hungary
Debrecen University Clinical Center, Orthopedic Clinic
🇭🇺Debrecen, Hungary
Daegu Fatima Hospital
🇰🇷Daegu, Korea, Republic of
Istituto IRCCS G. Salini
🇮🇹Genoa, Italy
National Health Insurance Service Ilsan Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
PMG Research of Charlotte, LLC
🇺🇸Charlotte, North Carolina, United States
Rady Children's Hospital San Diego
🇺🇸San Diego, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Road Runner Research
🇺🇸San Antonio, Texas, United States
Baylor College of Medicine Texas Children's Hospital
🇺🇸Houston, Texas, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Hasbro Children's Hospital
🇺🇸Providence, Rhode Island, United States