Clinical trial NCT01603628: BOTOX® Treatment in Pediatric Lower Limb Spasticity
Official title: BOTOX® Treatment in Pediatric Lower Limb Spasticity: Double-blind 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: 384
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.


Eligibility criteria: Inclusion Criteria:

* Minimum weight of 10 kg/22 lb
* Cerebral palsy with dynamic muscle contracture /spasticity 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 6 months
* History of surgical intervention of the lower study leg or planned surgery of any limb during the study
* Previous casting of the study limb for spasticity within 6 months or with a dynamic splint within 3 months, or planned casting or dynamic splinting for spasticity of the study limb or affected upper limb during the study

Primary outcomes:
measure: Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Ankle Score With Knee Extended at Weeks 4 and 6
timeFrame: Baseline (Day 1) to Weeks 4 and 6
measure: Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6
timeFrame: Weeks 4 and 6
Secondary outcomes:
measure: Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale
timeFrame: Weeks 8 and 12
measure: Change From Baseline in Severity of Spasticity of the Ankle With Knee Extended and Knee Flexed (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)
timeFrame: Baseline (Day 1) to Weeks 2, 4, 6, 8 and 12
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: AMS Neurology
state: California
city: Pomona
country: United States
facility: Harrison Clinical Management
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado Dept. of PM&R
state: Colorado
city: Fairfield
country: United States
facility: Associated Neurologists of Southern CT, P.C.
state: Connecticut
city: Stamford
country: United States
facility: New England Center 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, PA
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: Rehab Institute of Chicago
state: Illinois
city: Kansas City
country: United States
facility: The Children's Mercy Hospital & Clinics
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 Medical Center 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: Rhode Island 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
city: Debrecen
country: Hungary
facility: Debrecen University Clinical Center, Orthopedic Clinic
city: Genoa
country: Italy
facility: Istituto IRCCS G. Gaslini
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: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Quezon City
country: Philippines
facility: Philippine Orthopedic Center
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center-Quezon City
city: Quezon City
country: Philippines
facility: Philippine Children's Medical Center
city: Białystok
country: Poland
facility: Uniwersytecki Dzieciecy Szpita
city: Gdansk
country: Poland
facility: Uni Centrum Kliniczne
city: Gdansk
country: Poland
facility: Centrum Rehabilitacji Krok po Kroku
city: Krakow
country: Poland
facility: Specjal. Gabinet Neurologiczny
city: Lublin
country: Poland
facility: INTERMED, Lublin
city: Lublin
country: Poland
facility: CRH ŻAGIEL MED, Lublin
city: Rzeszów
country: Poland
facility: Szpital Wojewódzki Nr 2
city: Warsaw
country: Poland
facility: Neuro - 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: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
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: Rozalina Dimitrova
role: STUDY_DIRECTOR
References: