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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01603615
Other study ID # 191622-105
Secondary ID 2012-000043-27
Status Completed
Phase Phase 3
First received
Last updated
Start date October 30, 2012
Est. completion date September 3, 2018

Study information

Verified date July 2019
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
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 upper limb spasticity.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date September 3, 2018
Est. primary completion date September 3, 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)

- Upper limb spasticity due to cerebral palsy or stroke

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 upper limb within 1 year, or planned surgery of any limb during the study

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Botulinum Toxin Type A
Participants received intramuscular injections of botulinum Toxin Type A in the upper and/or lower limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.

Locations

Country Name City State
Canada Holland Bloorview Kids Rehab Toronto Ontario
Hungary Debrecen University Clinical Center, Orthopedic Clinic Debrecen
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 De La Salle Health Sciences Institute Cavite
Philippines Philippine Children's Medical Center Quezon City
Poland Uni Centrum Kliniczne Gdansk
Poland Specjal. Gabinet Neurologiczny Krakow
Poland Centrum Medyczne "POMOC" Lodz
Poland CRH ZAGIEL MED, Lublin Lublin
Poland INTERMED, Lublin Lublin
Poland Centrum Profilatyki I Terapii 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 Siriraj Hospital Dept of Rehabilitation Medicine, Faculty of Medicine Bangkok
Thailand Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University Chiang Mai
Thailand Srinagarind Hospital, Khon Kaen University Khon Kaen
Turkey Kocaeli Üniversitesi Kocaeli
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 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 & 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 Pediatric Physical Medicine & Rehabilitation, Dept. of Rehabilitation & Regenerative Medicine Harkness New York New York
United States NYU Hospital for Joint Diseases New York New York
United States Pediatric Neurology, PA Orlando Florida
United States ABS Health, LLC Pasadena California
United States Harrison Clinical Management Pomona California
United States Washington University School of Medicine Saint Louis Missouri
United States Gillette Children's Specialty Healthcare Saint Paul Minnesota
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 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,  Canada,  Hungary,  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. Safety population included all treated participants. From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)
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