BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity
- Conditions
- PediatricsCerebral PalsyStrokeMuscle Spasticity
- Interventions
- Biological: Botulinum Toxin Type A
- Registration Number
- NCT01603615
- Lead Sponsor
- Allergan
- Brief Summary
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric upper limb spasticity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- Minimum weight of 10 Kilograms (kg) / 22 Pounds (lb)
- Upper limb spasticity due to cerebral palsy or stroke
- 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 upper limb 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 a maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into upper limb and/or lower limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment, de novo participants received at least 6 U/kg of body weight or a maximum of 8 U/kg of body weight (not to exceed 300 U). Rollover participants received up to a maximum of 8 U/kg of body weight (not to exceed 300 U) for treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Rolled over participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 or 6 U/kg into upper limb in previous study or were de novo participants who were not enrolled in 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. Safety population included all treated participants.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (48)
ABS Health, LLC
🇺🇸Pasadena, California, United States
Harrison Clinical Management
🇺🇸Pomona, California, United States
Rady Children's Hospital San Diego
🇺🇸San Diego, California, United States
Children's Healthcare of Atlanta Children's Rehabilitation Associates
🇺🇸Atlanta, Georgia, United States
NYU Hospital for Joint Diseases
🇺🇸New York, New York, United States
The Children's Mercy Hospital & Clinics
🇺🇸Kansas City, Missouri, United States
Columbia University Pediatric Physical Medicine & Rehabilitation, Dept. of Rehabilitation & Regenerative Medicine Harkness
🇺🇸New York, New York, United States
OnSite Clinical Solutions, LLC
🇺🇸Charlotte, North Carolina, United States
Road Runner Research
🇺🇸San Antonio, Texas, United States
PMG Research of Charlotte, LLC
🇺🇸Charlotte, North Carolina, United States
Baylor College of Medicine Texas Children's Hospital
🇺🇸Houston, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
De La Salle Health Sciences Institute
🇵🇭Cavite, Philippines
CRH ŻAGIEL MED, Lublin
🇵🇱Lublin, Poland
NZOZ Mazowieckie Centrum
🇵🇱Warsaw, Poland
Clinical Research Center of New Jersey
🇺🇸Voorhees, New Jersey, United States
Associated Neurologists of Southern Connecticut, P.C.
🇺🇸Fairfield, Connecticut, United States
New England Center for Clinical Research
🇺🇸Stamford, Connecticut, United States
Pediatric Neurology, PA
🇺🇸Orlando, Florida, United States
Debrecen University Clinical Center, Orthopedic Clinic
🇭🇺Debrecen, Hungary
NW FL Clinical Research Group, LLC
🇺🇸Gulf Breeze, Florida, United States
Axcess Medical Research, LLC
🇺🇸Loxahatchee Groves, Florida, United States
National Health Insurance Service Ilsan Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Uni Centrum Kliniczne
🇵🇱Gdansk, Poland
Centrum Medyczne "POMOC"
🇵🇱Lodz, Poland
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Daegu Fatima Hospital
🇰🇷Daegu, Korea, Republic of
Holland Bloorview Kids Rehab
🇨🇦Toronto, Ontario, Canada
Philippine Children's Medical Center
🇵🇭Quezon City, Philippines
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Kocaeli Üniversitesi
🇹🇷Kocaeli, Turkey
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Specjal. Gabinet Neurologiczny
🇵🇱Krakow, Poland
Childrens Republic Hospital
🇷🇺Kazan, Russian Federation
Smolensk Regional Hospital- Regional Budget State Healthcare institution
🇷🇺Smolensk, Russian Federation
Siriraj Hospital Dept of Rehabilitation Medicine, Faculty of Medicine
🇹🇭Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
🇹🇭Chiang Mai, Thailand
INTERMED, Lublin
🇵🇱Lublin, Poland
Centrum Profilatyki I Terapii
🇵🇱Warsaw, Poland
Tyumen Regional Hospital #2 - State Budget Healthcare Institution of Tyumen region
🇷🇺Tyumen, Russian Federation
Srinagarind Hospital, Khon Kaen University
🇹🇭Khon Kaen, Thailand
Children's Hospital Colorado Dept. of PM&R
🇺🇸Aurora, Colorado, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Gillette Children's Specialty Healthcare
🇺🇸Saint Paul, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States