BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity

Cerebral Palsy Clinical Trial

Official title:

BOTOX® Treatment in Pediatric Lower Limb Spasticity: Open-label Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603641
• Other study ID #: 191622-112
• Secondary ID: 2012-000084-24
• Status: Completed
• Phase: Phase 3
• Start date: November 5, 2012
• Est. completion date: August 25, 2018

Study information

• Verified date: July 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: August 25, 2018
• Est. primary completion date: August 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

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 the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.

Locations

Country	Name	City	State
Hungary	Semmelweis Egyetem- Ortopédiai Klinika Karolina út 27	Budapest
Hungary	Debrecen University Clinical Center, Orthopedic Clinic	Debrecen
Italy	Istituto IRCCS G. Salini	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
Poland	Uniwersytecki Dzieciecy Szpita	Bialystok
Poland	Centrum Rehabilitacji Krok po Kroku	Gdansk
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Specjalistyczny Gabinet Neurologiczny	Krakow
Poland	Centrum Medyczne "POMOC"	Lodz
Poland	CRH ZAGIEL MED, Lublin	Lublin
Poland	INTERMED, Lublin	Lublin
Poland	Szpital Wojewodzki Nr 2	Rzeszow
Poland	NZOZ Mazowieckie Centrum	Warsaw
Poland	Poradnia Rehab - Neurologiczneij dla Dzieci I Mlodziezy Aga	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 ChiangMai Hospital	ChiangMai
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	Aurora	Colorado
United States	OnSite Clinical Solutions, LLC	Charlotte	North Carolina
United States	PMG Research of Charlotte, LLC	Charlotte	North Carolina
United States	Shirley Ryan Ability Lab	Chicago	Illinois
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Associated Neurologists of Southern Connecticut, 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	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 Dept. of Rehab. & Regenerative Medicine	New York	New York
United States	NYU Hospital for Joint Diseases	New York	New York
United States	Pediatric Neurology, P.A.	Orlando	Florida
United States	ABS Health, LLC	Pasadena	California
United States	Harrison Clinical Management	Pomona	California
United States	Hasbro Children's Hospital	Providence	Rhode Island
United States	Beaumont Children's Hospital Pediatric Research	Royal Oak	Michigan
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Road Runner Research	San Antonio	Texas
United States	Rady Children's Hospital San Diego	San Diego	California
United States	Seattle Children's Hospital	Seattle	Washington
United States	New England Institute 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	Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)	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.	From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)

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