BOTOX® Treatment in Pediatric Lower Limb Spasticity

Cerebral Palsy Clinical Trial

Official title:

BOTOX® Treatment in Pediatric Lower Limb Spasticity: Double-blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603628
• Other study ID #: 191622-111
• Secondary ID: 2012-000042-35
• Status: Completed
• Phase: Phase 3
• Start date: September 11, 2012
• Est. completion date: June 28, 2017

Study information

• Verified date: July 2018
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Pediatrics

Intervention

Biological:
• botulinum toxin Type A
Participants received intramuscular injections of botulinum toxin Type A into specified muscles of the lower limb on Day 1.

Drug:
• Normal Saline (Placebo)
Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb on Day 1.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Hungary,  Italy,  Korea, Republic of,  Philippines,  Poland,  Russian Federation,  Thailand,  Turkey, 

Outcome

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

External Links

•   Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.