Cerebral Palsy Clinical Trial
Official title:
BOTOX® Treatment in Pediatric Lower Limb Spasticity: Double-blind Study
Verified date | July 2018 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.
Status | Completed |
Enrollment | 384 |
Est. completion date | June 28, 2017 |
Est. primary completion date | June 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 16 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Hungary | Semmelweis Egyetem- Ortopédiai Klinika | Budapest | |
Hungary | Debrecen University Clinical Center, Orthopedic Clinic | Debrecen | |
Italy | Istituto IRCCS G. Gaslini | Genoa | |
Korea, Republic of | Daegu Fatima Hospital | Daegu | |
Korea, Republic of | National Health Insurance Service Ilsan Hospital | Gyeonggi-do | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
Philippines | Philippine Children's Medical Center | Quezon City | |
Philippines | Philippine Orthopedic Center | Quezon City | |
Philippines | St. Luke's Medical Center-Quezon City | Quezon City | |
Poland | Uniwersytecki Dzieciecy Szpita | Bialystok | |
Poland | Centrum Rehabilitacji Krok po Kroku | Gdansk | |
Poland | Uni Centrum Kliniczne | Gdansk | |
Poland | Specjal. Gabinet Neurologiczny | Krakow | |
Poland | CRH ZAGIEL MED, Lublin | Lublin | |
Poland | INTERMED, Lublin | Lublin | |
Poland | Szpital Wojewódzki Nr 2 | Rzeszów | |
Poland | Neuro - Dzieci I Mlodziezy Aga | Warsaw | |
Poland | NZOZ Mazowieckie Centrum | Warsaw | |
Russian Federation | Childrens Republic Hospital | Kazan | |
Russian Federation | Smolensk Regional Hospital- Regional Budget State Healthcare institution | Smolensk | |
Russian Federation | Tyumen Regional Hospital #2 - State Budget Healthcare Institution of Tyumen region | Tyumen | |
Thailand | Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University | Chiang Mai | |
Thailand | Srinagarind Hospital, Khon Kaen University | Khon Kaen | |
Turkey | Ankara Diskapi Yildrim Beyazit | Ankara | |
Turkey | Kocaeli Üniversitesi | Kocaeli | |
Turkey | Selçuk Üniversitesi | Konya | |
United States | Children's Healthcare of Atlanta Children's Rehabilitation Associates | Atlanta | Georgia |
United States | Children's Hospital Colorado Dept. of PM&R | Aurora | Colorado |
United States | OnSite Clinical Solutions, LLC | Charlotte | North Carolina |
United States | PMG Research of Charlotte, LLC | Charlotte | North Carolina |
United States | Rehab Institute of Chicago | Chicago | Illinois |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Associated Neurologists of Southern CT, P.C. | Fairfield | Connecticut |
United States | NW FL Clinical Research Group, LLC | Gulf Breeze | Florida |
United States | Baylor College of Medicine Texas Children's Hospital | Houston | Texas |
United States | The Children's Mercy Hospital & Clinics | Kansas City | Missouri |
United States | Axcess Medical Research, LLC | Loxahatchee Groves | Florida |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Columbia University Medical Center Dept. of Rehab. & Regenerative Medicine | New York | New York |
United States | NYU Hospital for Joint Diseases | New York | New York |
United States | Pediatric Neurology, PA | Orlando | Florida |
United States | AMS Neurology | Pasadena | California |
United States | Harrison Clinical Management | Pomona | California |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Road Runner Research | San Antonio | Texas |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | New England Center for Clinical Research | Stamford | Connecticut |
United States | Clinical Research Center of New Jersey | Voorhees | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Allergan |
United States, Hungary, Italy, Korea, Republic of, Philippines, Poland, Russian Federation, Thailand, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Ankle Score With Knee Extended at Weeks 4 and 6 | The MAS-B was used to evaluate spasticity based on grading the resistance encountered in the principal muscle group (elbow and wrist) by means of passively moving a limb through its range of motion at a study specified velocity. The resistance encountered to passive stretch was graded using a 6-point scale where: 0=no increase in muscle tone (best) to 4=affected part(s) rigid in flexion or extension (worst). For analysis purposes, the MAS-B was recoded as follows: 0=1, 1=1, 1+=2, 2=3, 3=4, 4=5. The scores at Weeks 4 and 6 were averaged. A Mixed Model Repeated Measures (MMRM) model was used for analysis. A negative change from Baseline indicates improvement. | Baseline (Day 1) to Weeks 4 and 6 | |
Primary | Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6 | The CGI of overall change (improvement or worsening) was assessed by the physician considering the participant's clinical condition and severity of side effects using a 9-point scale where: -4=very marked worsening to +4=very marked improvement. The scores at Weeks 4 and 6 were averaged. A Mixed Model Repeated Measures (MMRM) model was used for analysis. | Weeks 4 and 6 | |
Secondary | Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale | Two functional goals, one active and one passive, were selected by the participant and family in consultation with the physician investigator and/or treating physical therapist relative to the lower limb impairment due to spasticity. The physician assessed the achievement of the goals using a 6-point scale: where -3=worse than start to +2=much more than expected: improvements clearly exceed the defined therapeutic goal. An Analysis of Covariance (ANCOVA) model was used for analysis. | Weeks 8 and 12 | |
Secondary | 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) | The MTS measured the difference between slow and fast range of motion (R2-R1) and respective change from baseline to each posttreatment office visit. The MTS of the ankle was used to determine the passive range of movement at different movement velocities, V1 (as slow as possible) and V3 (as fast as possible) with the relative difference between a slow and fast velocity passive stretch determining the dynamic component of the muscle contracture for the joint. The investigator measured 2 joint angles by goniometer: the R1 angle which is the angle of catch after a fast velocity (V3) stretch and the R2 angle defined as the passive joint range of movement following a slow velocity (V1) stretch. The R2-R1 value indicated the level of the dynamic component of spasticity in the joint. The difference between R2 and R1 range of motion and respective change from baseline to each posttreatment office visit on the MTS was derived. An Analysis of Covariance (ANCOVA) model was used for analysis. | Baseline (Day 1) to Weeks 2, 4, 6, 8 and 12 |
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