Clinical trial NCT01603641: BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity
Official title: BOTOX® Treatment in Pediatric Lower Limb Spasticity: Open-label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pediatrics
Muscle Spasticity
Cerebral Palsy
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-05-22
Enrollment: 370
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
timeFrame: From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: ABS Health, LLC
state: California
city: Pomona
country: United States
facility: Harrison Clinical Management
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Fairfield
country: United States
facility: Associated Neurologists of Southern Connecticut, P.C.
state: Connecticut
city: Stamford
country: United States
facility: New England Institute for Clinical Research
state: Connecticut
city: Gulf Breeze
country: United States
facility: NW FL Clinical Research Group, LLC
state: Florida
city: Loxahatchee Groves
country: United States
facility: Axcess Medical Research, LLC
state: Florida
city: Orlando
country: United States
facility: Pediatric Neurology, P.A.
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta Children's Rehabilitation Associates
state: Georgia
city: Chicago
country: United States
facility: Shirley Ryan Ability Lab
state: Illinois
city: Royal Oak
country: United States
facility: Beaumont Children's Hospital Pediatric Research
state: Michigan
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Voorhees
country: United States
facility: Clinical Research Center of New Jersey
state: New Jersey
city: New York
country: United States
facility: NYU Hospital for Joint Diseases
state: New York
city: New York
country: United States
facility: Columbia University Dept. of Rehab. & Regenerative Medicine
state: New York
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC
state: North Carolina
city: Charlotte
country: United States
facility: PMG Research of Charlotte, LLC
state: North Carolina
city: Providence
country: United States
facility: Hasbro Children's Hospital
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine Texas Children's Hospital
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Budapest
country: Hungary
facility: Semmelweis Egyetem- Ortopédiai Klinika Karolina út 27
city: Debrecen
country: Hungary
facility: Debrecen University Clinical Center, Orthopedic Clinic
city: Genoa
country: Italy
facility: Istituto IRCCS G. Salini
city: Daegu
country: Korea, Republic of
facility: Daegu Fatima Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Quezon City
country: Philippines
facility: Philippine Orthopedic Center
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
city: Quezon City
country: Philippines
facility: Philippine Children's Medical Center
city: Białystok
country: Poland
facility: Uniwersytecki Dzieciecy Szpita
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Gdansk
country: Poland
facility: Centrum Rehabilitacji Krok po Kroku
city: Krakow
country: Poland
facility: Specjalistyczny Gabinet Neurologiczny
city: Lodz
country: Poland
facility: Centrum Medyczne "POMOC"
city: Lublin
country: Poland
facility: INTERMED, Lublin
city: Lublin
country: Poland
facility: CRH ŻAGIEL MED, Lublin
city: Rzeszow
country: Poland
facility: Szpital Wojewodzki Nr 2
city: Warsaw
country: Poland
facility: Poradnia Rehab - Neurologiczneij dla Dzieci I Mlodziezy Aga
city: Warsaw
country: Poland
facility: NZOZ Mazowieckie Centrum
city: Kazan
country: Russian Federation
facility: Childrens Republic Hospital
city: Smolensk
country: Russian Federation
facility: Smolensk Regional Hospital- Regional Budget State Healthcare institution
city: Tyumen
country: Russian Federation
facility: Tyumen Regional Hospital #2 - State Budget Healthcare Institution of Tyumen region
city: ChiangMai
country: Thailand
facility: Maharaj Nakorn ChiangMai Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Khon Kaen University
city: Ankara
country: Turkey
facility: Ankara Diskapi Yildrim Beyazit
city: Kocaeli
country: Turkey
facility: Kocaeli Üniversitesi
city: Konya
country: Turkey
facility: Selçuk Üniversitesi
Study officials:
affiliation: Allergan
name: Emily McCusker
role: STUDY_DIRECTOR
References: